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Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery

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ClinicalTrials.gov Identifier: NCT00175448
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 25, 2008
Sponsor:
Information provided by:
University of British Columbia

Brief Summary:
A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home Exercise Program Following Discharge Home from Total Hip Arthroplasty

Condition or disease Intervention/treatment
Arthritis Arthroscopic Hip Surgery Procedure: physiotherapy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Outpatient Physiotherapy Versus a Self-Administered Home Exercise Program Following Discharge Home From Total Hip Arthroplasty
Study Start Date : September 2005
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: physiotherapy
    See Detailed Description.


Primary Outcome Measures :
  1. Physical function at 16 weeks post THA in patients who received outpatient physiotherapy following discharge home compared to unsupervised self- directed exercises alone (as measured by the WOMAC). [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA? [ Time Frame: 2 years ]
  2. Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in:
  3. generic health-related QOL (SF-36) and (HUI3)
  4. pain and stiffness (WOMAC pain and stiffness)
  5. activities of daily living (FSI)
  6. patient satisfaction (Brigham and Women's patient satisfaction)
  7. objective physical function (TUG, Harris Hip, Gait Lab)
  8. What is the marginal cost effectiveness of outpatient physiotherapy versus self-directed exercises?
  9. How does the recovery over time compare between programs (trajectory of recovery) ?
  10. What is the difference in musculoskeletal adverse event rate (ie dislocation)?


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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary THA (cemented or cementless)
  • preoperative diagnosis of osteoarthritis (primary or secondary)
  • meets objective discharge-to-home test following hip replacement
  • ability to speak English and reply to questionnaires written in English
  • ability to provide informed consent
  • may include patients presenting for their second primary hip arthroplasty

Discharge to Home Criteria

  • independent supine-to-sit transfer
  • independent sit-to-stand transfer
  • walk with walking aid 30 meters
  • ascend and descend 3 stairs
  • deemed medically fit and safe for home environment by surgeon/nursing/PT

Exclusion Criteria:

  • surgery as part of a workers' compensation claim
  • arthroplasty performed for trauma or following open reduction and internal fixation, malignancy or inflammatory arthropathy
  • intra-operative complication of fracture or sciatic nerve injury
  • procedure requiring complex surgical approach other than posterior or anterolateral (ie trochanteric osteotomy/micro 2 incision approach)
  • indications for additional primary or revision arthroplasty within the time frame of the study (24 months) in other hip or knee joints which would adversely affect quality of life and functional scores pertaining to the joint of interest

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175448


Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Nelson Greidanus, MD University of British Columbia

Responsible Party: Dr. Nelson Greidanus, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175448     History of Changes
Other Study ID Numbers: C02-0249
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2005