Clinical trial NCT00175448: Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery
Official title: A Randomized Controlled Trial of Outpatient Physiotherapy Versus a Self-Administered Home Exercise Program Following Discharge Home From Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Arthroscopic Hip Surgery
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 144
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: 16 weeks
Secondary outcomes:
measure: Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA?
timeFrame: 2 years
measure: Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in:
measure: generic health-related QOL (SF-36) and (HUI3)
measure: pain and stiffness (WOMAC pain and stiffness)
measure: activities of daily living (FSI)
measure: patient satisfaction (Brigham and Women's patient satisfaction)
measure: objective physical function (TUG, Harris Hip, Gait Lab)
measure: What is the marginal cost effectiveness of outpatient physiotherapy versus self-directed exercises?
measure: How does the recovery over time compare between programs (trajectory of recovery) ?
measure: What is the difference in musculoskeletal adverse event rate (ie dislocation)?
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Nelson Greidanus, MD
role: PRINCIPAL_INVESTIGATOR
References: