Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175448
• Other study ID #: C02-0249
• 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

• Arthritis
• Arthroscopic Hip Surgery

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