Arthroplasty, Replacement, KneeNCT03039907
Return to Physical Activities After Total Knee Arthroplasty
An observational study of Arthroplasty, Replacement, Knee, run by Cincinnati Sportsmedicine Research and Education Foundation at 1 site in United States.
Trial summary
The main purpose of this study is to examine the factors that allow patients that undergo total knee arthroplasty to return to recreational sports and/or work activities, and to achieve recommended physical activity levels. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2017to 1 Jul 2022
- How long will I take part?
- 2 Years
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients 65 years of age and younger who undergo total knee arthroplasty who desire to return to recreational (sports) and/or work activities postoperatively.
Who may be able to join
- Men or women 65 years of age or younger.
- Patient indicates before surgery the desire to return to recreational (sports) and/or work activities postoperatively
- Patient provides informed consent.
- Patient complies with postoperative rehabilitation program.
Who cannot join
- Patient did not desire to return to recreational and/or work activities after TKA
- History of alcohol or drug abuse within 3 years of the operation.
- Disabling or widespread osteoarthritis or other joint disease in any other joint.
- Presence of a significant connective tissue disease, autoimmune disease, HIV-positive, or immune deficiency syndrome.
- Any other contraindications that in the opinion of the principal investigator would interfere with the conduct of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, 45242
Cassie Fleckenstein, M.S., 513-794-8466, cfleckenstein@csmref.org
Frank Noyes, M.D.
About this study
Official title: A Critical Assessment of the Factors That Promote or Limit the Return to Recreational, Work, and Physical Fitness Activities After Primary Total Knee Arthroplasty
The main purpose of this study is to examine the factors that allow patients that undergo total knee arthroplasty to return to recreational sports and/or work activities, and to achieve recommended physical activity levels.
Read the detailed description
There are three purposes of this study. The first purpose is to examine the factors that allow patients that underwent total knee arthroplasty with the Journey II to return to recreational sports and/or work activities, and to achieve recommended physical activity levels (defined by the American Heart Association and the American College of Sports Medicine).
The second purpose is to examine the factors that limit the ability of patients to resume sports, work, and physical fitness training, including comorbidities, general health, complications, and other factors.
The third purpose is to use advanced sports medicine rehabilitation principles that involve staged progressive protocols to safely prepare patients for sports, work, and physical fitness training. Objective measurements of muscle strength, endurance, balance, and neuromuscular control will be used to determine when patients may be cleared to participate in these activities.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Total Knee Arthroplasty
- Keywords
- Knee, Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Total knee arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Number of Participants That Return to Recreational and Fitness Activities
Participants will complete a questionnaire that determines the type of physical activities they routinely participate in (for instance, swimming, bicycling, hiking, golf). Patients will also complete two questions regarding their general fitness level in accordance with current standards of the American Heart Association. These questions are contained in the study patient registry.
Measured: 2 years postoperatively
Secondary outcomes (3)
Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities
Patient comorbidities will be documented by the surgeon using the weighted Charlson Comorbidity Index. An analysis will be conducted to determine if the index score has a deleterious effect on recreational activities or general fitness activities at follow-up.
Measured: 2 years postoperatively
Assessment of Postoperative Complications on Return to Recreational and Physical Activities
All postoperative complications will be documented in the study patient registry with a list related specifically to TKA from the AKS and a second general list that was generated from complications recorded by the Centers for Medicare and Medicaid Services (2015 update). An analysis will be conducted to determine if complications have a deleterious effect on recreational activities or general fitness activities patients return to after surgery.
Measured: 2 years postoperatively
Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities
Patient body mass index will be collected before surgery and will be designated as either obese, over weight, or within normal limits according to WHO classification of obesity. Determination will be made of the effect of BMI on return to recreational or general fitness activities at follow-up.
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start23 Jan 2017
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation
- Investigators
- Frank R Noyes, MD, Principal investigator, Cincinnati Sportsmedicine and Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039907
- Sponsor's protocol ID
- TKAUnder65-001
- Status last verified
- Oct 2020
- First submitted
- 11 Apr 2016
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Critical Assessment of the Factors That Promote or Limit the Return to Recreational, Work, and Physical Fitness Activities After Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03039907
- Acronym / sponsor ID
- TKAUnder65-001
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Knee, Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education FoundationUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 1 Feb 2017 (estimated)
- 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 main purpose of this study is to examine the factors that allow patients that undergo total knee arthroplasty to return to recreational sports and/or work activities, and to achieve recommended physical activity levels.
Detailed description
There are three purposes of this study. The first purpose is to examine the factors that allow patients that underwent total knee arthroplasty with the Journey II to return to recreational sports and/or work activities, and to achieve recommended physical activity levels (defined by the American Heart Association and the American College of Sports Medicine).
The second purpose is to examine the factors that limit the ability of patients to resume sports, work, and physical fitness training, including comorbidities, general health, complications, and other factors.
The third purpose is to use advanced sports medicine rehabilitation principles that involve staged progressive protocols to safely prepare patients for sports, work, and physical fitness training. Objective measurements of muscle strength, endurance, balance, and neuromuscular control will be used to determine when patients may be cleared to participate in these activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients 65 years of age and younger who undergo total knee arthroplasty who desire to return to recreational (sports) and/or work activities postoperatively.
Key inclusion criteria (4 listed)
- Men or women 65 years of age or younger.
- Patient indicates before surgery the desire to return to recreational (sports) and/or work activities postoperatively
- Patient provides informed consent.
- Patient complies with postoperative rehabilitation program.
Key exclusion criteria (5 listed)
- Patient did not desire to return to recreational and/or work activities after TKA
- History of alcohol or drug abuse within 3 years of the operation.
- Disabling or widespread osteoarthritis or other joint disease in any other joint.
- Presence of a significant connective tissue disease, autoimmune disease, HIV-positive, or immune deficiency syndrome.
- Any other contraindications that in the opinion of the principal investigator would interfere with the conduct of the study.
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 ArthroplastyTotal knee arthroplasty | Procedure or surgery | – |
Primary outcome
Analysis of Number of Participants That Return to Recreational and Fitness Activities
Time frame: 2 years postoperatively
Participants will complete a questionnaire that determines the type of physical activities they routinely participate in (for instance, swimming, bicycling, hiking, golf). Patients will also complete two questions regarding their general fitness level in accordance with current standards of the American Heart Association. These questions are contained in the study patient registry.
3 secondary outcomes
Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities
Time frame: 2 years postoperatively
Assessment of Postoperative Complications on Return to Recreational and Physical Activities
Time frame: 2 years postoperatively
Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities
Time frame: 2 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Yes
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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 Arthroplasty, Replacement, Knee, 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 4 inclusion and 5 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 8 Oct 2020. 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 Frank R Noyes, MD (513-347-9999, frnoyes@gmaili.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Number of Participants That Return to Recreational and Fitness Activities (time frame: 2 years postoperatively). 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 8 Oct 2020.