Unrestricted Rehabilitation Following Primary THA

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Dr. Veronica Wadey, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02079467
First received: December 4, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Osteoarthritis, Hip
Procedure: Unrestricted rehabilitation
Procedure: Standard rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Unrestricted Rehabilitation Following Primary Total Hip Arthroplasty: Implications for Patient Satisfaction and Functional Performance

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Timed Up and Go (TUG) [ Time Frame: Six weeks post-operatively ] [ Designated as safety issue: No ]
    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:
  • 4-Item Pain Intensity Measure (P4) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Timed Up and Go (TUG) [ Time Frame: Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks) ] [ Designated as safety issue: No ]
    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.

  • Timed Up and Go (TUG) [ Time Frame: Eighteen weeks post-operatively ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 Minute Walk Test (6MWT) [ Time Frame: Six weeks post-operatively ] [ Designated as safety issue: No ]
    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 Minute Walk Test (6MWT) [ Time Frame: Eighteen weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • 4-Item Pain Intensity Measure (P4) [ Time Frame: Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks) ] [ Designated as safety issue: No ]
    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.

  • 4-Item Pain Intensity Measure (P4) [ Time Frame: Six weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • 4-Item Pain Intensity Measure (P4) [ Time Frame: Eighteen weeks post-operatively ] [ Designated as safety issue: No ]
    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) [ Time Frame: Six weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • Lower extremity functional scale (LEFS) [ Time Frame: Eighteen weeks post-operatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: Six weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing [ Time Frame: Eighteen weeks post-operatively ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: December 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079467

Contacts
Contact: Mark W Miller, MD 416-381-0957 mark.miller@sunnybrook.ca

Locations
Canada, Ontario
Holland Orthopaedic and Arthritic Centre Recruiting
Toronto, Ontario, Canada, M4Y 1H1
Contact: Mark W Miller, MD       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         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr. Veronica Wadey, Staff surgeon, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02079467     History of Changes
Other Study ID Numbers: Miller-01
Study First Received: December 4, 2013
Last Updated: March 4, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Arthroplasty, Hip
Replacement, Hip
Postoperative Care
Rehabilitation

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014