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Clinical Trials/NCT03120052
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.

Registry
clinicaltrials.gov
Start Date
January 8, 2018
End Date
December 8, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

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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