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Completed

NCT Number: NCT03120052

Physical Therapy Components for Maximum TKR Outcome

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Replacement Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Massachusetts Medical SChool

Worcester, Massachusetts, 01655, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Differences in knee specific functional gain at 6 months

    Time frame: 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.

  2. Differences in knee performance measures at 6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Defining Components of Physical Therapy Achieving Maximum Function After Total Knee Replacement

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 19, 2017
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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