Clinical trial NCT02079467: Unrestricted Rehabilitation Following Primary THA
Official title: Unrestricted Rehabilitation Following Primary Total Hip Arthroplasty: Implications for Patient Satisfaction and Functional Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Arthroplasty, Hip
Replacement, Hip
Postoperative Care
Rehabilitation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: Six weeks post-operatively
Secondary outcomes:
measure: 4-Item Pain Intensity Measure (P4)
timeFrame: Baseline
measure: Lower extremity functional scale (LEFS)
timeFrame: Baseline
measure: PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing
timeFrame: Baseline
measure: Timed Up and Go (TUG)
timeFrame: Baseline
measure: Timed Up and Go (TUG)
timeFrame: Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks)
measure: Timed Up and Go (TUG)
timeFrame: Eighteen weeks post-operatively
measure: Six Minute Walk Test (6MWT)
timeFrame: Baseline
measure: Six Minute Walk Test (6MWT)
timeFrame: Six weeks post-operatively
measure: Six Minute Walk Test (6MWT)
timeFrame: Eighteen weeks post-operatively
measure: 4-Item Pain Intensity Measure (P4)
timeFrame: Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks)
measure: 4-Item Pain Intensity Measure (P4)
timeFrame: Six weeks post-operatively
measure: 4-Item Pain Intensity Measure (P4)
timeFrame: Eighteen weeks post-operatively
measure: Lower extremity functional scale (LEFS)
timeFrame: Six weeks post-operatively
measure: Lower extremity functional scale (LEFS)
timeFrame: Eighteen weeks post-operatively
measure: PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing
timeFrame: Six weeks post-operatively
measure: PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing
timeFrame: Eighteen weeks post-operatively
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Orthopaedic and Arthritic Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre, University of Toronto
name: Hans J Kreder, MD MPH FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre, University of Toronto
name: Richard Jenkinson, MD MSC FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre, University of Toronto
name: Veronica MR Wadey, BPHE BEd MD MA FRCSC
role: PRINCIPAL_INVESTIGATOR
References: