Unrestricted Rehabilitation Following Primary THA

Not Applicable

• Conditions: Osteoarthritis, Hip

• Registration Number: NCT02079467
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

The purpose of this study is to determine whether the form of rehabilitation following primary total hip arthroplasty has an influence on patient satisfaction or functional performance in the eighteen weeks following surgery.

Detailed Description

The current standard of care following total hip replacement is to restrict patient activity and range-of-motion with the goal of avoiding dislocation of the operative hip. These restrictions are commonly referred to as "hip precautions". Several recent studies have demonstrated these precautions may be safely abandoned with no increased risk of dislocation when the surgery is carried through an anterior/lateral approach. Previous work has failed to address the issue of patient satisfaction and functional performance when patients are managed with an unrestricted rehabilitation protocol post-operatively. We propose a prospective, randomized clinical trial to determine whether an unrestricted postoperative rehabilitation protocol has an impact on patient satisfaction and functional performance following primary total hip arthroplasty.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-04
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-04
• Last Update Submitted: 2014-03-04
• Study First Posted: 2014-03-05
• Last Update Posted: 2014-03-05
• Primary Completion: 2014-06
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age greater than 50 years
• Undergoing primary total hip arthroplasty at Holland Orthopaedic and Arthritic Centre

Exclusion Criteria

• Any previous surgery about the ipsilateral hip
• Patients being considered for simultaneous bilateral total hip arthroplasty
• Patients with a neuromuscular disorder or recognized hypermobility syndrome
• Patients without sufficient language skills to communicate in spoken and written English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Timed Up and Go (TUG)	Six weeks post-operatively	The test involves measuring the duration of time required for a patient to rise from a standard arm chair, walk 3 metres, turn, walk back to the chair, and sit down.

Secondary Outcome Measures

Name	Time	Method
4-Item Pain Intensity Measure (P4)	Eighteen weeks post-operatively	The measure involves patients recording the subjective experience of their pain on a scale from 0 - 10 at different times during the day (morning, afternoon, evening) as well as with activity.
Lower extremity functional scale (LEFS)	Eighteen weeks post-operatively	The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention.
PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing	Eighteen weeks post-operatively	This is a tool developed by the National Institutes of Health (NIH) which uses item response theory to select questions from a validated item bank to get a precise measurement of patient status in a chosen domain.
Timed Up and Go (TUG)	Eighteen weeks post-operatively	The test involves measuring the duration of time required for a patient to rise from a standard arm chair, walk 3 metres, turn, walk back to the chair, and sit down.
Six Minute Walk Test (6MWT)	Eighteen weeks post-operatively	This test involves the measurement of the total distance an individual is able to walk over a period of six minutes along a marked pathway with time allowed to rest as required.

Trial Locations

Locations (1)

Holland Orthopaedic and Arthritic Centre; 🇨🇦 Toronto, Ontario, Canada