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Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175448
First received: September 11, 2005
Last updated: September 24, 2008
Last verified: September 2005
  Purpose

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


Condition Intervention
Arthritis
Arthroscopic Hip Surgery
Procedure: physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA? [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in: [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • generic health-related QOL (SF-36) and (HUI3) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • pain and stiffness (WOMAC pain and stiffness) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • activities of daily living (FSI) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • patient satisfaction (Brigham and Women's patient satisfaction) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • objective physical function (TUG, Harris Hip, Gait Lab) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • What is the marginal cost effectiveness of outpatient physiotherapy versus self-directed exercises? [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • How does the recovery over time compare between programs (trajectory of recovery) ? [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • What is the difference in musculoskeletal adverse event rate (ie dislocation)? [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: September 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: physiotherapy
    See Detailed Description.
  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175448

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

No publications provided

Responsible Party: Dr. Nelson Greidanus, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175448     History of Changes
Other Study ID Numbers: C02-0249
Study First Received: September 11, 2005
Last Updated: September 24, 2008
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on November 25, 2014