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Completed

NCT Number: NCT00175448

Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery

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

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Key information

Conditions

Arthritis Arthroscopic Hip Surgery Joint Diseases Musculoskeletal Diseases

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physiotherapy

Procedure

See Detailed Description.

Primary outcomes

  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 outcomes

  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)?

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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