Unrestricted Rehabilitation Following Primary THA

Study Overview
=================
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.

Official Title
-----------------
Unrestricted Rehabilitation Following Primary Total Hip Arthroplasty: Implications for Patient Satisfaction and Functional Performance

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Procedure: Unrestricted rehabilitation
* Procedure: Standard rehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard rehabilitation<br>Patients 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. | Procedure: Standard rehabilitation<br>* Standard care range of motion restrictions will remain in place<br>|
| Experimental: Unrestricted rehabilitation<br>Patients 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. | Procedure: Unrestricted rehabilitation<br>* Standard care range of motion restrictions will not be used<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go (TUG) | 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 weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-Item Pain Intensity Measure (P4) | 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. | Baseline | 
| Lower extremity functional scale (LEFS) | 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. | Baseline | 
| PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing | 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. | Baseline | 
| Timed Up and Go (TUG) | 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. | Baseline | 
| Timed Up and Go (TUG) | 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. | Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks) | 
| Timed Up and Go (TUG) | 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. | Eighteen weeks post-operatively | 
| Six Minute Walk Test (6MWT) | 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. | Baseline | 
| Six Minute Walk Test (6MWT) | 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. | Six weeks post-operatively | 
| Six Minute Walk Test (6MWT) | 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. | Eighteen weeks post-operatively | 
| 4-Item Pain Intensity Measure (P4) | 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. | Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks) | 
| 4-Item Pain Intensity Measure (P4) | 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. | Six weeks post-operatively | 
| 4-Item Pain Intensity Measure (P4) | 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. | Eighteen weeks post-operatively | 
| Lower extremity functional scale (LEFS) | 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. | Six weeks post-operatively | 
| Lower extremity functional scale (LEFS) | 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. | Eighteen weeks post-operatively | 
| PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing | 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. | Six weeks post-operatively | 
| PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing | 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. | Eighteen weeks post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Hip, Replacement, Hip, Postoperative Care, Rehabilitation