Unrestricted Rehabilitation Following Primary THA

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02079467
• Other study ID #: Miller-01
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2013
• Last updated: March 4, 2014
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: Mark W Miller, MD
• Phone: 416-381-0957
• Email: mark.miller[@]sunnybrook.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Procedure:
• Unrestricted rehabilitation
Standard care range of motion restrictions will not be used
• Standard rehabilitation
Standard care range of motion restrictions will remain in place

Locations

Country	Name	City	State
Canada	Holland Orthopaedic and Arthritic Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No