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Physical Therapy Prior to Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02279277
Recruitment Status : Unknown
Verified October 2014 by Rothman Institute Orthopaedics.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Hip Behavioral: Supervised physical therapy program prior to total knee replacement surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Physical Therapy on Grade 3 or 4 Knee Osteoarthritis
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: No physical therapy
No prescribed, supervised physical therapy prior to total knee replacement
Active Comparator: Physical Therapy
Prescribed, supervised physical therapy prior to total knee replacement
Behavioral: Supervised physical therapy program prior to total knee replacement surgery

Primary Outcome Measures :
  1. Range of Motion following Total Knee Replacement [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Patient reported perception of pain following total knee replacement [ Time Frame: 6 weeks ]
  2. Return to functional activities following total knee replacement [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Rothman Institute Orthopaedics Identifier: NCT02279277    
Other Study ID Numbers: Austin2014
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases