Total Knee ArthroplastyNCT04746144
Return Physical Activities After Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty, run by Cincinnati Sportsmedicine Research and Education Foundation at 1 site in United States.
Trial summary
The ability to resume physical activities, aerobic fitness and a healthy lifestyle without symptoms after total knee arthroplasty (TKA) remains unclear because studies show high rates of patient dissatisfaction. Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2013to 1 Jan 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 Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients were selected from the treating surgeon's patient population.
Who may be able to join
- Age < 70 years
- Patient goals to return to recreational and occupational activities
- Agree to participate in a postoperative rehabilitation and home exercise program
Who cannot join
- Osteoarthritis in other joints
- Co-morbidities limiting physical activity
- Presence of a connective tissue disease
- Autoimmune disease or immune deficiency
- Age 70 years or more
- no desire to return to recreational and work activities
- Refusal to participate in rehabilitation program
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, 45242
About this study
Official title: Return to Physical Activities and Aerobic Fitness After Total Knee Arthroplasty in Younger Patients
The ability to resume physical activities, aerobic fitness and a healthy lifestyle without symptoms after total knee arthroplasty (TKA) remains unclear because studies show high rates of patient dissatisfaction. The aim of this study was to evaluate whether an individualized goal-centered rehabilitation protocol leads to high patient-reported physical activities and satisfaction after TKA.
Read the detailed description
A prospective study was conducted in patients who underwent primary TKA (Journey II, Smith \& Nephew) from the same surgeon from July 1, 2013 to December 31, 2015. Patients completed patient-reported outcome measures (PROMs) before the operation and then at 1, 2, and 4 years postoperatively.These included the Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS JR) 7-item score; questions from the Cincinnati Knee Rating System related to the overall knee condition, pain, and swelling; selected questions from the Veterans RAND 12-Item Health Survey; questions about general fitness level; and questions regarding patient expectations before and after surgery. Patients were asked to list all physical, recreational, and work activities they participated in after surgery. An experienced research associate interviewed the patients postoperatively, with data reduction and patient ratings blinded to the treating surgeon and therapist.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score
Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.
Measured: Preoperative
Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score
Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.
Measured: 4 years postoperative
Documentation of sports and recreational activities
Patients provide a list of all sports and recreational activities they participated in after surgery. This is an open-ended question "What sports or recreational activities do you participate in on a regular basis?"
Measured: 4 years postoperative
Secondary outcomes (12)
Cincinnati Knee Rating Pain Score
Scored on a point scale where patient selects 0, 2, 4, or 6; where 0 = severe pain constant with daily activities, 2 = moderate pain with activities of daily living, 4 = able to do activities of daily living with no pain, and 6 = no pain with recreational activities
Measured: Preoperative
Cincinnati Knee Rating Pain Score
Scored on a point scale where patient selects 0, 2, 4, or 6; where 0 = severe pain constant with daily activities, 2 = moderate pain with activities of daily living, 4 = able to do activities of daily living with no pain, and 6 = no pain with recreational activities
Measured: 4 years postoperative
Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score
Score for the patient rating of the overall knee condition (0-10 point scale where 0 = poor and 10 = excellent)
Measured: Preoperative
Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score
Score for the patient rating of the overall knee condition (0-10 point scale where 0 = poor and 10 = excellent)
Measured: 4 years postoperative
Cincinnati Knee Rating Swelling Score
Scored on a point scale where patient selects 0, 2, 4, or 6; where 0 = severe swelling constant with daily activities, 2 = moderate swelling with activities of daily living, 4 = able to do activities of daily living with no swelling, and 6 = no swelling with recreational activities
Measured: Preoperative
Cincinnati Knee Rating Swelling Score
Scored on a point scale where patient selects 0, 2, 4, or 6; where 0 = severe swelling constant with daily activities, 2 = moderate swelling with activities of daily living, 4 = able to do activities of daily living with no swelling, and 6 = no swelling with recreational activities
Measured: 4 years postoperative
Aerobic fitness levels
Two questions are completed:
- Are you able to take a brisk 20-minute walk that raises your heart rate 5 days a week?
- Are you able to spend 20 minutes doing vigorous aerobic activity that causes a large increase in your heart rate 3 days a week? Scale for both questions: Yes; No, because of pain in my knee; No, because of pain in another joint; No, because of other reasons
Measured: Preoperative
Aerobic fitness levels
Two questions are completed:
- Are you able to take a brisk 20-minute walk that raises your heart rate 5 days a week?
- Are you able to spend 20 minutes doing vigorous aerobic activity that causes a large increase in your heart rate 3 days a week? Scale for both questions: Yes; No, because of pain in my knee; No, because of pain in another joint; No, because of other reasons
Measured: 4 years postoperative
Work Status
Single question: Are you able to work:
Patients select: Yes, with no limitations; Yes, with limitations; No, Retired or does not apply
Measured: Preoperative
Work Status
Single question: Are you able to work:
Patients select: Yes, with no limitations; Yes, with limitations; No, Retired or does not apply
Measured: 4 years postoperative
Patient Expectations After Surgery
4 questions:
- My expectations for being able to do my normal activities of daily living after the knee surgery were:
- My expectations for being able to do my leisure, recreational or sports activities after the knee surgery were: Scale for first 2 questions: Too low, I'm a lot better than I thought; Too low, I'm somewhat better than I thought; Just right, my expectations were met; Too high, I'm somewhat worse than I thought; Too high, I'm a lot worse than I thought.
- Was your surgery worthwhile; are you glad you underwent the procedure? Scale: Yes, definitely; Yes, probably; No, probably; No, definitely
- Compare the overall condition of your knee now to what it was before your surgery.
Scale: Great deal better, Somewhat better, The same, Somewhat worse, Great deal worse
Measured: 4 years postoperative
Patient Expectations Before Surgery
2 questions:
- I expect that, after my knee surgery, activities such as walking, stairs, and kneeling to be:
- I expect that, after my knee surgery, recreational activities such as bicycling, hiking, golf, light tennis, to be:
Scale for both questions: Fully normal with no limitation; Almost normal with some limitations; Improved, but may have some problems; Improved, but may have bothersome problems; Not possible or not interested in recreational activities
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jul 2013
- Primary completion31 Dec 2015
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank R Noyes, MD, Principal investigator, Cincinnati Sportsmedicine and Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746144
- Sponsor's protocol ID
- TKRActivity13-15
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 9 Feb 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 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Physical Activities and Aerobic Fitness After Total Knee Arthroplasty in Younger Patients
- ClinicalTrials.gov ID
- NCT04746144
- Acronym / sponsor ID
- TKRActivity13-15
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education FoundationUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 9 Feb 2021 (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.
The ability to resume physical activities, aerobic fitness and a healthy lifestyle without symptoms after total knee arthroplasty (TKA) remains unclear because studies show high rates of patient dissatisfaction. The aim of this study was to evaluate whether an individualized goal-centered rehabilitation protocol leads to high patient-reported physical activities and satisfaction after TKA.
Detailed description
A prospective study was conducted in patients who underwent primary TKA (Journey II, Smith \& Nephew) from the same surgeon from July 1, 2013 to December 31, 2015. Patients completed patient-reported outcome measures (PROMs) before the operation and then at 1, 2, and 4 years postoperatively.These included the Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS JR) 7-item score; questions from the Cincinnati Knee Rating System related to the overall knee condition, pain, and swelling; selected questions from the Veterans RAND 12-Item Health Survey; questions about general fitness level; and questions regarding patient expectations before and after surgery. Patients were asked to list all physical, recreational, and work activities they participated in after surgery. An experienced research associate interviewed the patients postoperatively, with data reduction and patient ratings blinded to the treating surgeon and therapist.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients were selected from the treating surgeon's patient population.
Key inclusion criteria (3 listed)
- Age < 70 years
- Patient goals to return to recreational and occupational activities
- Agree to participate in a postoperative rehabilitation and home exercise program
Key exclusion criteria (7 listed)
- Osteoarthritis in other joints
- Co-morbidities limiting physical activity
- Presence of a connective tissue disease
- Autoimmune disease or immune deficiency
- Age 70 years or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplasty | Procedure or surgery | – |
Primary outcome
Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score
Time frame: Preoperative
Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.
Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score
Time frame: 4 years postoperative
Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.
Documentation of sports and recreational activities
Time frame: 4 years postoperative
Patients provide a list of all sports and recreational activities they participated in after surgery. This is an open-ended question "What sports or recreational activities do you participate in on a regular basis?"
12 secondary outcomes
Cincinnati Knee Rating Pain Score
Time frame: Preoperative
Cincinnati Knee Rating Pain Score
Time frame: 4 years postoperative
Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score
Time frame: Preoperative
Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score
Time frame: 4 years postoperative
Cincinnati Knee Rating Swelling Score
Time frame: Preoperative
Cincinnati Knee Rating Swelling Score
Time frame: 4 years postoperative
Aerobic fitness levels
Time frame: Preoperative
Aerobic fitness levels
Time frame: 4 years postoperative
Work Status
Time frame: Preoperative
Work Status
Time frame: 4 years postoperative
Patient Expectations After Surgery
Time frame: 4 years postoperative
Patient Expectations Before Surgery
Time frame: Preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty
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Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
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Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
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ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
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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.
Frank R Noyes, MD principal investigator
Cincinnati Sportsmedicine and Orthopaedic Center
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 Total Knee Arthroplasty, run by Cincinnati Sportsmedicine Research and Education Foundation 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score (time frame: Preoperative). The study lists 3 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 9 Feb 2021.