Clinical trial NCT03120052: Physical Therapy Components for Maximum TKR Outcome
Official title: Defining Components of Physical Therapy Achieving Maximum Function After Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Knee Replacement
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2017-04-19
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients electing total knee replacement at one of participating PT sites.

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.


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

Primary outcomes:
measure: Differences in overall functional gain at 6 months
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Differences in knee specific functional gain at 6 months
timeFrame: 6 month follow-up
measure: Differences in knee performance measures at 6 months
timeFrame: 6 month follow-up
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical SChool
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Patricia D Franklin, MD, MBA, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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