Physical Therapy Components for Maximum TKR Outcome

Completed

• Conditions: Knee Replacement; Knee Osteoarthritis

• Registration Number: NCT03120052
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-19
• Study Start: 2018-01-08
• Primary Completion: 2020-12-08
• Study Completion: 2020-12-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in overall functional gain at 6 months	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 Outcome Measures

Name	Time	Method
Differences in knee specific functional gain at 6 months	6 month follow-up	Differences in pre-operative to 6 month post-operative functional gain, using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) by physical therapy regimen.
Differences in knee performance measures at 6 months	6 month follow-up	Differences in pre-operative to 6-month post -operative knee performance measures using the Physical Therapy Performance Measures (includes a 5 minute stair climbing exercise, a 6 minute walking exercise and a sit to stand exercise) by physical therapy regimen.

Trial Locations

Locations (1)

University of Massachusetts Medical SChool; 🇺🇸 Worcester, Massachusetts, United States