NCT03120052
Completed
Not Applicable
Defining Components of Physical Therapy Achieving Maximum Function After Total Knee Replacement
University of Massachusetts, Worcester1 site in 1 country161 target enrollmentJanuary 8, 2018
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- University of Massachusetts, Worcester
- Enrollment
- 161
- Locations
- 1
- Primary Endpoint
- Differences in overall functional gain at 6 months
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The overall goal of this study is to identify what Physical Therapy care components are associated with the best patient-reported functional outcome after Total Knee Replacement (TKR) surgery. The investigators are specifically looking at outcomes at 6 and 12 months after surgery.
Investigators
Patricia Franklin
Principal Investigator
University of Massachusetts, Worcester
Eligibility Criteria
Inclusion Criteria
- •Are scheduled to undergo an elective, unilateral primary total knee replacement due to knee osteoarthritis
- •Will receive outpatient PT from a participating physical therapist.
- •Agree to record their exercise and activity for specific time points in the study.
Exclusion Criteria
- •Total knee replacement scheduled for indications other than OA (e.g., fracture, malignancy, infection, or revision or prior implant)
- •The inability to obtain informed consent due to cognitive conditions.
- •Non-English speakers as the materials used in this project have not yet been tested with non-English speakers
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
Outcomes
Primary Outcomes
Differences in overall functional gain at 6 months
Time Frame: 6 month follow-up
Differences in pre-operative to 6 month post -operative functional gain, using the SF-36 Physical Component Summary (PCS) Score by physical therapy regimen.
Secondary Outcomes
- Differences in knee specific functional gain at 6 months(6 month follow-up)
- Differences in knee performance measures at 6 months(6 month follow-up)
Study Sites (1)
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