- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03039907
Return to Physical Activities After Total Knee Arthroplasty
A Critical Assessment of the Factors That Promote or Limit the Return to Recreational, Work, and Physical Fitness Activities After Primary Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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Ohio
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Cincinnati, Ohio, United States, 45242
- Recruiting
- Cincinnati Sportsmedicine and Orthopaedic Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities
Time Frame: 2 years postoperatively
|
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.
|
2 years postoperatively
|
Assessment of Postoperative Complications on Return to Recreational and Physical Activities
Time Frame: 2 years postoperatively
|
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.
|
2 years postoperatively
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Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities
Time Frame: 2 years postoperatively
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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.
|
2 years postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TKAUnder65-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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