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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00175448
Other study ID # C02-0249
Secondary ID
Status Completed
Phase N/A
First received September 11, 2005
Last updated September 24, 2008
Start date September 2005
Est. completion date December 2007

Study information

Verified date September 2005
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
physiotherapy
See Detailed Description.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 16 weeks No
Secondary Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA? 2 years No
Secondary Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in: Unspecified No
Secondary generic health-related QOL (SF-36) and (HUI3) Unspecified No
Secondary pain and stiffness (WOMAC pain and stiffness) Unspecified No
Secondary activities of daily living (FSI) Unspecified No
Secondary patient satisfaction (Brigham and Women's patient satisfaction) Unspecified No
Secondary objective physical function (TUG, Harris Hip, Gait Lab) Unspecified No
Secondary What is the marginal cost effectiveness of outpatient physiotherapy versus self-directed exercises? Unspecified No
Secondary How does the recovery over time compare between programs (trajectory of recovery) ? Unspecified No
Secondary What is the difference in musculoskeletal adverse event rate (ie dislocation)? Unspecified No
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