Unrestricted Rehabilitation Following Primary THA

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Procedure: Standard rehabilitation; Procedure: Unrestricted rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4Y 1H1
      • Recruiting
      • Holland Orthopaedic and Arthritic Centre
      • Contact: Mark W Miller, MD; Email: mark.miller@sunnybrook.ca
      • Principal Investigator: Hans J Kreder, MD MPH FRCSC
      • Principal Investigator: Richard Jenkinson, MD MSC FRCSC
      • Principal Investigator: Veronica MR Wadey, BPHE BEd MD MA FRCSC
      • Sub-Investigator: Markku Nousiainen, MD MSC MEd FRCSC
      • Sub-Investigator: Jeffrey Gollish, MD FRCSC
      • Sub-Investigator: Rohit Jain, MBBS MS(Orth) MRCSEd FRCSEd
      • Sub-Investigator: Mark W Miller, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard rehabilitation; 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; Standard care range of motion restrictions will remain in place
EXPERIMENTAL: Unrestricted rehabilitation; 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; Standard care range of motion restrictions will not be used

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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Hans J Kreder, MD MPH FRCSC, Sunnybrook Health Sciences Centre, University of Toronto; Principal Investigator: Richard Jenkinson, MD MSC FRCSC, Sunnybrook Health Sciences Centre, University of Toronto; Principal Investigator: Veronica MR Wadey, BPHE BEd MD MA FRCSC, Sunnybrook Health Sciences Centre, University of Toronto

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): June 1, 2014
• Study Completion (ANTICIPATED): November 1, 2014

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (ESTIMATE): March 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 5, 2014
• Last Update Submitted That Met QC Criteria: March 4, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Postoperative Care; Arthroplasty, Hip; Replacement, Hip
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: Miller-01