Osteoarthritis, HipNCT02079467
Unrestricted Rehabilitation Following Primary THA
A study testing Unrestricted rehabilitation and Standard rehabilitation in people with Osteoarthritis, Hip, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Unrestricted rehabilitation and Standard rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 50 years
- Undergoing primary total hip arthroplasty at Holland Orthopaedic and Arthritic Centre
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Holland Orthopaedic and Arthritic Centre
Toronto, Ontario, M4Y 1H1
Mark W Miller, MD, mark.miller@sunnybrook.ca
Hans J Kreder, MD MPH FRCSC
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Unrestricted rehabilitation, Standard rehabilitation
- Keywords
- Arthroplasty, Hip, Replacement, Hip, Postoperative Care, Rehabilitation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unrestricted rehabilitationProcedure or surgery
Standard care range of motion restrictions will not be used
Standard rehabilitationProcedure or surgery
Standard care range of motion restrictions will remain in place
| Study group | Role | What they receive |
|---|---|---|
| Standard rehabilitation | Active comparator | 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. Receives: Procedure: Standard rehabilitation |
| Unrestricted rehabilitation | Experimental | 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. Receives: Procedure: Unrestricted rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six weeks post-operatively
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Eighteen weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Veronica Wadey, Sunnybrook Health Sciences Centre
- Investigators
- Hans J Kreder, MD MPH FRCSC, Principal investigator, Sunnybrook Health Sciences Centre, University of TorontoRichard Jenkinson, MD MSC FRCSC, Principal investigator, Sunnybrook Health Sciences Centre, University of TorontoVeronica MR Wadey, BPHE BEd MD MA FRCSC, Principal investigator, Sunnybrook Health Sciences Centre, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079467
- Sponsor's protocol ID
- Miller-01
- Status last verified
- Mar 2014
- First submitted
- 4 Dec 2013
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unrestricted Rehabilitation Following Primary Total Hip Arthroplasty: Implications for Patient Satisfaction and Functional Performance
- ClinicalTrials.gov ID
- NCT02079467
- Acronym / sponsor ID
- Miller-01
- Conditions
- Osteoarthritis, Hip
- Keywords
- Arthroplasty, Hip, Replacement, Hip, Postoperative Care, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation | Active comparator | Procedure: Standard rehabilitationPatients 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. |
| Unrestricted rehabilitation | Experimental | Procedure: Unrestricted rehabilitationPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 50 years
- Undergoing primary total hip arthroplasty at Holland Orthopaedic and Arthritic Centre
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unrestricted rehabilitationStandard care range of motion restrictions will not be used | Procedure or surgery | Unrestricted rehabilitation |
| Standard rehabilitationStandard care range of motion restrictions will remain in place | Procedure or surgery | Standard rehabilitation |
Primary outcome
Timed Up and Go (TUG)
Time frame: Six weeks post-operatively
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.
16 secondary outcomes
4-Item Pain Intensity Measure (P4)
Time frame: Baseline
Lower extremity functional scale (LEFS)
Time frame: Baseline
PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing
Time frame: Baseline
Timed Up and Go (TUG)
Time frame: Baseline
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)
Timed Up and Go (TUG)
Time frame: Eighteen weeks post-operatively
Six Minute Walk Test (6MWT)
Time frame: Baseline
Six Minute Walk Test (6MWT)
Time frame: Six weeks post-operatively
Six Minute Walk Test (6MWT)
Time frame: Eighteen weeks post-operatively
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)
4-Item Pain Intensity Measure (P4)
Time frame: Six weeks post-operatively
4-Item Pain Intensity Measure (P4)
Time frame: Eighteen weeks post-operatively
Lower extremity functional scale (LEFS)
Time frame: Six weeks post-operatively
Lower extremity functional scale (LEFS)
Time frame: Eighteen weeks post-operatively
PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing
Time frame: Six weeks post-operatively
PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing
Time frame: Eighteen weeks post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans J Kreder, MD MPH FRCSC principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
Richard Jenkinson, MD MSC FRCSC principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
Veronica MR Wadey, BPHE BEd MD MA FRCSC principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unrestricted rehabilitation and Standard rehabilitation in people with Osteoarthritis, Hip, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark W Miller, MD (416-381-0957, mark.miller@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: Six weeks post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.