Anterior Cruciate Ligament Injury(COFAKS)NCT03700996
Clinical Outcome Following Arthroscopic Knee Surgery
An observational study of Anterior Cruciate Ligament Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Purpose: There are no existing data available to guide clinicians in the appropriate rehabilitation progression of patients who have undergone knee arthroscopy. The investigator intends to fill this void by establishing normative recovery curves for patients undergoing knee arthroscopy. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2014to 23 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Exclusion Criteria: * will be surgical candidates who have elected surgical intervention for internal derangement of the knee.
Who may be able to join
- Ages 10-70; undergoing primary knee arthroscopy; \& participating in post-operative physical therapy management.
Who cannot join
- Patients will be excluded from the study if they elect to not have knee arthroscopy. Have other orthopedic or medical complications (fractures, deep vein thrombosis,) that would be a contraindication to standard post-operative physical therapy care.
Trial locations and contacts
1 site in 1 country.
Lane Bailey, PhD, PT contact
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center-Houston
Houston, Texas, 77030
Lane Bailey, PhD, PT, lane.bailey@uth.tmc.edu
Lane Bailey, PhD, PT
About this study
Official title: Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)
Purpose: There are no existing data available to guide clinicians in the appropriate rehabilitation progression of patients who have undergone knee arthroscopy. The investigator intends to fill this void by establishing normative recovery curves for patients undergoing knee arthroscopy.
Research Design: Prospective Observational Design Procedures: Patients 10-70 years old will be screened for "standard of care" clinical and functional outcomes to occur at standardized time-points (post-op weeks 1-4, 8, 12, 16, 20 and return to sport/activity) following arthroscopic knee surgery. Recovery curves will be plotted for all outcome variables of interest including; (1) International knee Disability Committee (IKDC) survey, (2) Tampa Kinesiophobia scale, (3) Tegner activity scale, (4) Marx activity scale, (5) Passive knee range of motion/heel-height difference, (6) Balance Error Scoring System (BESS), (7) Quad/Hamstring strength ratios, (8) Y-Balance, (9) Functional Movement Screening, (10) Vail-Sport Test, (11) Landing Error Scoring System (LESS), (12) Hop Testing, and the (13) Sports Metrics Test. Polynomial lines-of-best-fit and 95% confidence intervals will be plotted to provide objective recovery curves for clinical utilization and stratification of patient recovery.
Read more
Risks: There are no additional risks to "standard physical therapy practice" for post-surgical patients participating in this study. The investigator will not be using invasive procedures or testing modalities that emit radiation.
Benefits \& Clinical Relevance: This information may offer valuable information to clinicians treating patients following knee arthroscopy by providing objective data for each phase of post-operative recovery. Identifying key landmarks and functional milestones may allow the ability to identify patients who are not meeting clinical expectations and subsequently tailor rehabilitation programs to improve recovery trajectories.
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 4
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 5
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 6
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 7
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 8
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 9
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 10
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 11
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 12
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 13
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 14
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 15
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 16
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 17
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 18
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 19
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week 20
International Knee Disability Committee (IKDC) Survey
Self-Report Outcomes:
The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Measured: Post op week Return to Sport: range 21 weeks to 52 weeks
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 4
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 5
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 6
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 7
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 8
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 9
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 10
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 11
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 12
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 13
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 14
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 15
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 16
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 17
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 18
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 19
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week 20
Marx Scale
Self-Report Outcomes:
MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Measured: Post op week Return to Sport: range 21 weeks to 52 weeks
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 4
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 5
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 6
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 7
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 8
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 9
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 10
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 11
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 12
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 13
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 14
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 15
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 16
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 17
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 18
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 19
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week 20
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Self-Report Outcomes:
Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Measured: Post op week Return to Sport: range 21 weeks to 52 weeks
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 4
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 5
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 6
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 7
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 8
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 9
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 10
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 11
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 12
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 13
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 14
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 15
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 16
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 17
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 18
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 19
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week 20
Range of Motion
Clinical Measures:
The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Measured: Post op week Return to Sport: range 21 weeks to 52 weeks
Y-Balance
Physical Performance
Measured: Post op week 8
Y-Balance
Physical Performance
Measured: Post op week 9
Y-Balance
Physical Performance
Measured: Post op week 10
Y-Balance
Physical Performance
Measured: Post op week 11
Y-Balance
Physical Performance
Measured: Post op week 12
Y-Balance
Physical Performance
Measured: Post op week 13
Y-Balance
Physical Performance
Measured: Post op week 14
Y-Balance
Physical Performance
Measured: Post op week 15
Y-Balance
Physical Performance
Measured: Post op week 16
Y-Balance
Physical Performance
Measured: Post op week 17
Y-Balance
Physical Performance
Measured: Post op week 18
Y-Balance
Physical Performance
Measured: Post op week 19
Y-Balance
Physical Performance
Measured: Post op week 20
Y-Balance
Physical Performance
Measured: Post op week Return to Sport: range 21 weeks to 52 weeks
Single Leg Hop
Physical Performance
Measured: Post op week 8
Single Leg Hop
Physical Performance
Measured: Post op week 9
Single Leg Hop
Physical Performance
Measured: Post op week 10
Single Leg Hop
Physical Performance
Measured: Post op week 11
Single Leg Hop
Physical Performance
Measured: Post op week 12
Single Leg Hop
Physical Performance
Measured: Post op week 13
Single Leg Hop
Physical Performance
Measured: Post op week 14
Single Leg Hop
Physical Performance
Measured: Post op week 15
Single Leg Hop
Physical Performance
Measured: Post op week 16
Single Leg Hop
Physical Performance
Measured: Post op week 17
Single Leg Hop
Physical Performance
Measured: Post op week 18
Single Leg Hop
Physical Performance
Measured: Post op week 19
Single Leg Hop
Physical Performance
Measured: Post op week 20
Single Leg Hop
Physical Performance
Measured: Post op week Return to Sport: range 21 weeks to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start23 Oct 2014
- Primary completion23 Dec 2021 (estimated)
- Study completion23 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Responsible party
- Principal investigator, Lane Bailey, The University of Texas Health Science Center, Houston
- Investigators
- Lane Bailey, Principal investigator, Memorial Hermann Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700996
- Sponsor's protocol ID
- HSC-MH-14-0734 (Parent Study)
- Acronym
- (COFAKS)
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2018
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)
- ClinicalTrials.gov ID
- NCT03700996
- Acronym / sponsor ID
- (COFAKS) / HSC-MH-14-0734 (Parent Study)
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 23 Dec 2021 (estimated)
- Study completion
- 23 Dec 2021 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: There are no existing data available to guide clinicians in the appropriate rehabilitation progression of patients who have undergone knee arthroscopy. The investigator intends to fill this void by establishing normative recovery curves for patients undergoing knee arthroscopy.
Research Design: Prospective Observational Design Procedures: Patients 10-70 years old will be screened for "standard of care" clinical and functional outcomes to occur at standardized time-points (post-op weeks 1-4, 8, 12, 16, 20 and return to sport/activity) following arthroscopic knee surgery. Recovery curves will be plotted for all outcome variables of interest including; (1) International knee Disability Committee (IKDC) survey, (2) Tampa Kinesiophobia scale, (3) Tegner activity scale, (4) Marx activity scale, (5) Passive knee range of motion/heel-height difference, (6) Balance Error Scoring System (BESS), (7) Quad/Hamstring strength ratios, (8) Y-Balance, (9) Functional Movement Screening, (10) Vail-Sport Test, (11) Landing Error Scoring System (LESS), (12) Hop Testing, and the (13) Sports Metrics Test. Polynomial lines-of-best-fit and 95% confidence intervals will be plotted to provide objective recovery curves for clinical utilization and stratification of patient recovery.
Risks: There are no additional risks to "standard physical therapy practice" for post-surgical patients participating in this study. The investigator will not be using invasive procedures or testing modalities that emit radiation.
Benefits \& Clinical Relevance: This information may offer valuable information to clinicians treating patients following knee arthroscopy by providing objective data for each phase of post-operative recovery. Identifying key landmarks and functional milestones may allow the ability to identify patients who are not meeting clinical expectations and subsequently tailor rehabilitation programs to improve recovery trajectories.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Exclusion Criteria: * will be surgical candidates who have elected surgical intervention for internal derangement of the knee.
Key inclusion criteria (1 listed)
- Ages 10-70; undergoing primary knee arthroscopy; \& participating in post-operative physical therapy management.
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if they elect to not have knee arthroscopy. Have other orthopedic or medical complications (fractures, deep vein thrombosis,) that would be a contraindication to standard post-operative physical therapy care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 4
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 5
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 6
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 7
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 8
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 9
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 10
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 11
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 12
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 13
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 14
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 15
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 16
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 17
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 18
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 19
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week 20
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
International Knee Disability Committee (IKDC) Survey
Time frame: Post op week Return to Sport: range 21 weeks to 52 weeks
Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.
Marx Scale
Time frame: Post op week 4
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 5
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 6
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 7
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 8
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 9
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 10
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 11
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 12
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 13
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 14
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 15
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 16
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 17
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 18
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 19
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week 20
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Marx Scale
Time frame: Post op week Return to Sport: range 21 weeks to 52 weeks
Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 4
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 5
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 6
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 7
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 8
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 9
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 10
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 11
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 12
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 13
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 14
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 15
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 16
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 17
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 18
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 19
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week 20
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: Post op week Return to Sport: range 21 weeks to 52 weeks
Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.
Range of Motion
Time frame: Post op week 4
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 5
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 6
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 7
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 8
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 9
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 10
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 11
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 12
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 13
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 14
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 15
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 16
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 17
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 18
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 19
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week 20
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Range of Motion
Time frame: Post op week Return to Sport: range 21 weeks to 52 weeks
Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.
Y-Balance
Time frame: Post op week 8
Physical Performance
Y-Balance
Time frame: Post op week 9
Physical Performance
Y-Balance
Time frame: Post op week 10
Physical Performance
Y-Balance
Time frame: Post op week 11
Physical Performance
Y-Balance
Time frame: Post op week 12
Physical Performance
Y-Balance
Time frame: Post op week 13
Physical Performance
Y-Balance
Time frame: Post op week 14
Physical Performance
Y-Balance
Time frame: Post op week 15
Physical Performance
Y-Balance
Time frame: Post op week 16
Physical Performance
Y-Balance
Time frame: Post op week 17
Physical Performance
Y-Balance
Time frame: Post op week 18
Physical Performance
Y-Balance
Time frame: Post op week 19
Physical Performance
Y-Balance
Time frame: Post op week 20
Physical Performance
Y-Balance
Time frame: Post op week Return to Sport: range 21 weeks to 52 weeks
Physical Performance
Single Leg Hop
Time frame: Post op week 8
Physical Performance
Single Leg Hop
Time frame: Post op week 9
Physical Performance
Single Leg Hop
Time frame: Post op week 10
Physical Performance
Single Leg Hop
Time frame: Post op week 11
Physical Performance
Single Leg Hop
Time frame: Post op week 12
Physical Performance
Single Leg Hop
Time frame: Post op week 13
Physical Performance
Single Leg Hop
Time frame: Post op week 14
Physical Performance
Single Leg Hop
Time frame: Post op week 15
Physical Performance
Single Leg Hop
Time frame: Post op week 16
Physical Performance
Single Leg Hop
Time frame: Post op week 17
Physical Performance
Single Leg Hop
Time frame: Post op week 18
Physical Performance
Single Leg Hop
Time frame: Post op week 19
Physical Performance
Single Leg Hop
Time frame: Post op week 20
Physical Performance
Single Leg Hop
Time frame: Post op week Return to Sport: range 21 weeks to 52 weeks
Physical Performance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lane Bailey, PhD, PT contact
Lane Bailey principal investigator
Memorial Hermann Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lane Bailey, PhD, PT (lane.bailey@memorialhermann.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Disability Committee (IKDC) Survey (time frame: Post op week 4). The study lists 100 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.