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Unrestricted Rehabilitation Following Primary THA

Not Applicable
Conditions
Osteoarthritis, Hip
Interventions
Procedure: Standard rehabilitation
Procedure: Unrestricted rehabilitation
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.

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
Arm && Interventions
GroupInterventionDescription
Standard rehabilitationStandard rehabilitationPatients randomized to the control group will be managed with "hip precautions" immediately following surgery. They will weight bear on the operative joint as tolerated after surgery. They will be managed as per usual protocol post total hip arthroplasty. They will be transferred from the operative table with an abduction pillow between their legs and will be asked to keep this pillow between their legs while resting in bed and during sleep throughout their course in hospital. During physiotherapy treatments they will not flex the operative hip beyond 90 degrees, internally or externally rotate the operative hip more than 45 degrees, or actively adduct the operative hip past neutral.
Unrestricted rehabilitationUnrestricted rehabilitationPatients randomized to the treatment group will have no restrictions in their post-operative rehabilitation. They will weight bear on the operative joint as tolerated after surgery. They will be asked to participate in activity as their level of comfort permits and will have no positional restrictions while in bed or completing activities of daily living.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 TestingEighteen 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

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