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Physical Therapy Prior to Total Knee Replacement

Primary Purpose

Osteoarthritis of the Hip

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supervised physical therapy program prior to total knee replacement surgery
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph
  2. Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial
  3. Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction

Exclusion Criteria:

  1. Anyone who received physical therapy in the last 6 months
  2. Inability to walk unaided for >1 block
  3. Currently engaged in regular PT or a regular home exercise program
  4. Prior knee arthroplasty
  5. Prior knee surgery for trauma, tumor and osteotomy
  6. Injection given within 6 weeks of starting therapy
  7. Patients using daily narcotic medications within prior 6 weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    No physical therapy

    Physical Therapy

    Arm Description

    No prescribed, supervised physical therapy prior to total knee replacement

    Prescribed, supervised physical therapy prior to total knee replacement

    Outcomes

    Primary Outcome Measures

    Range of Motion following Total Knee Replacement

    Secondary Outcome Measures

    Patient reported perception of pain following total knee replacement
    Return to functional activities following total knee replacement

    Full Information

    First Posted
    October 6, 2014
    Last Updated
    October 28, 2014
    Sponsor
    Rothman Institute Orthopaedics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02279277
    Brief Title
    Physical Therapy Prior to Total Knee Replacement
    Official Title
    Effect of Physical Therapy on Grade 3 or 4 Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    148 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    No physical therapy
    Arm Type
    No Intervention
    Arm Description
    No prescribed, supervised physical therapy prior to total knee replacement
    Arm Title
    Physical Therapy
    Arm Type
    Active Comparator
    Arm Description
    Prescribed, supervised physical therapy prior to total knee replacement
    Intervention Type
    Behavioral
    Intervention Name(s)
    Supervised physical therapy program prior to total knee replacement surgery
    Primary Outcome Measure Information:
    Title
    Range of Motion following Total Knee Replacement
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Patient reported perception of pain following total knee replacement
    Time Frame
    6 weeks
    Title
    Return to functional activities following total knee replacement
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction Exclusion Criteria: Anyone who received physical therapy in the last 6 months Inability to walk unaided for >1 block Currently engaged in regular PT or a regular home exercise program Prior knee arthroplasty Prior knee surgery for trauma, tumor and osteotomy Injection given within 6 weeks of starting therapy Patients using daily narcotic medications within prior 6 weeks

    12. IPD Sharing Statement

    Learn more about this trial

    Physical Therapy Prior to Total Knee Replacement

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