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Unrestricted Rehabilitation Following Primary THA

Primary Purpose

Osteoarthritis, Hip

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Unrestricted rehabilitation
Standard rehabilitation
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Arthroplasty, Hip, Replacement, Hip, Postoperative Care, Rehabilitation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Holland Orthopaedic and Arthritic CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard rehabilitation

Unrestricted rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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 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 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 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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 4, 2013
Last Updated
March 4, 2014
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02079467
Brief Title
Unrestricted Rehabilitation Following Primary THA
Official Title
Unrestricted Rehabilitation Following Primary Total Hip Arthroplasty: Implications for Patient Satisfaction and Functional Performance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Arthroplasty, Hip, Replacement, Hip, Postoperative Care, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Unrestricted rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Unrestricted rehabilitation
Intervention Description
Standard care range of motion restrictions will not be used
Intervention Type
Procedure
Intervention Name(s)
Standard rehabilitation
Intervention Description
Standard care range of motion restrictions will remain in place
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
Six weeks post-operatively
Secondary Outcome Measure Information:
Title
4-Item Pain Intensity Measure (P4)
Description
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.
Time Frame
Baseline
Title
Lower extremity functional scale (LEFS)
Description
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.
Time Frame
Baseline
Title
PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing
Description
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.
Time Frame
Baseline
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
Baseline
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks)
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
Eighteen weeks post-operatively
Title
Six Minute Walk Test (6MWT)
Description
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.
Time Frame
Baseline
Title
Six Minute Walk Test (6MWT)
Description
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.
Time Frame
Six weeks post-operatively
Title
Six Minute Walk Test (6MWT)
Description
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.
Time Frame
Eighteen weeks post-operatively
Title
4-Item Pain Intensity Measure (P4)
Description
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.
Time Frame
Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks)
Title
4-Item Pain Intensity Measure (P4)
Description
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.
Time Frame
Six weeks post-operatively
Title
4-Item Pain Intensity Measure (P4)
Description
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.
Time Frame
Eighteen weeks post-operatively
Title
Lower extremity functional scale (LEFS)
Description
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.
Time Frame
Six weeks post-operatively
Title
Lower extremity functional scale (LEFS)
Description
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.
Time Frame
Eighteen weeks post-operatively
Title
PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing
Description
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.
Time Frame
Six weeks post-operatively
Title
PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing
Description
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.
Time Frame
Eighteen weeks post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark W Miller, MD
Phone
416-381-0957
Email
mark.miller@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans J Kreder, MD MPH FRCSC
Organizational Affiliation
Sunnybrook Health Sciences Centre, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Jenkinson, MD MSC FRCSC
Organizational Affiliation
Sunnybrook Health Sciences Centre, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Veronica MR Wadey, BPHE BEd MD MA FRCSC
Organizational Affiliation
Sunnybrook Health Sciences Centre, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Orthopaedic and Arthritic Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 1H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark W Miller, MD
Email
mark.miller@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Hans J Kreder, MD MPH FRCSC
First Name & Middle Initial & Last Name & Degree
Richard Jenkinson, MD MSC FRCSC
First Name & Middle Initial & Last Name & Degree
Veronica MR Wadey, BPHE BEd MD MA FRCSC
First Name & Middle Initial & Last Name & Degree
Markku Nousiainen, MD MSC MEd FRCSC
First Name & Middle Initial & Last Name & Degree
Jeffrey Gollish, MD FRCSC
First Name & Middle Initial & Last Name & Degree
Rohit Jain, MBBS MS(Orth) MRCSEd FRCSEd
First Name & Middle Initial & Last Name & Degree
Mark W Miller, MD

12. IPD Sharing Statement

Learn more about this trial

Unrestricted Rehabilitation Following Primary THA

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