Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery

September 24, 2008 updated by: University of British Columbia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: physiotherapy

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria