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PT vs no PT Following THA

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Outpatient physiotherapy
Self-guided physiotherapy
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Any patient undergoing unilateral primary total hip arthroplasty with age > 60

Exclusion Criteria:

  • Post-traumatic osteoarthritis
  • Rheumatoid arthritis or other peripheral inflammatory disease
  • Avascular necrosis
  • Revision or conversion THA
  • Post-septic osteoarthritis
  • Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Outpatient physiotherapy

    No outpatient physiotherapy

    Arm Description

    two weeks of in-home physiotherapy following total hip replacement followed by two months of outpatient physiotherapy with 2-3 weekly sessions

    two weeks of in-home physiotherapy following total hip replacement followed by two months of self-guided physiotherapy exercises

    Outcomes

    Primary Outcome Measures

    Harris Hip Score
    This is a validated instrument

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2016
    Last Updated
    March 14, 2016
    Sponsor
    Rothman Institute Orthopaedics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02687945
    Brief Title
    PT vs no PT Following THA
    Official Title
    Study to Evaluate Outpatient Physiotherapy in Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rothman Institute Orthopaedics

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if outpatient physiotherapy results in improved and/or more rapid achievement of functional outcomes and quality of life in comparison to those patients who do not undergo outpatient physiotherapy after total hip arthroplasty

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Arm Title
    Outpatient physiotherapy
    Arm Type
    Active Comparator
    Arm Description
    two weeks of in-home physiotherapy following total hip replacement followed by two months of outpatient physiotherapy with 2-3 weekly sessions
    Arm Title
    No outpatient physiotherapy
    Arm Type
    Active Comparator
    Arm Description
    two weeks of in-home physiotherapy following total hip replacement followed by two months of self-guided physiotherapy exercises
    Intervention Type
    Procedure
    Intervention Name(s)
    Outpatient physiotherapy
    Intervention Type
    Procedure
    Intervention Name(s)
    Self-guided physiotherapy
    Primary Outcome Measure Information:
    Title
    Harris Hip Score
    Description
    This is a validated instrument
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Eligibility Criteria
    Inclusion Criteria: Any patient undergoing unilateral primary total hip arthroplasty with age > 60 Exclusion Criteria: Post-traumatic osteoarthritis Rheumatoid arthritis or other peripheral inflammatory disease Avascular necrosis Revision or conversion THA Post-septic osteoarthritis Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home

    12. IPD Sharing Statement

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    PT vs no PT Following THA

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