- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00664508
Mobility Assessment of Patients With Total Hip Arthroplasty
January 2, 2024 updated by: Ottawa Hospital Research Institute
Mobility Assessment of Patients With Total Hip Arthroplasty: Joint Mechanics and Rehabilitation
The purpose of this study is to describe the 3D joint biomechanics of the lower extremities of patients having had a total hip replacement or hip resurfacing surgery as compared to a healthy age and weight matched control group during level walking, stair ascent and descent, and entering and exiting the front seat of a car.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Much research has shown that patients are generally satisfied with pain relief in the months and years following a total hip replacement (THR) or hip resurfacing procedure.
However, many express dissatisfaction with their ability to perform daily activities, a reduced walking ability and long-term lower extremity muscle weakness.
Given the general lack of knowledge surrounding joint motion of the lower extremities in the THR population, there is a need to characterize the joint mechanics of people having undergone THR, so that interventions and rehabilitation strategies can be designed to reduce post-operative complications and improve mobility.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y4E9
- OHRI
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 15 patients between the ages of 50 and 75 yrs having undergone a primary total hip replacement or hip resurfacing within 6 to 18 months of the study will participate, as well as an equal number of age, sex, height and weight matched healthy control participants.
Exclusion Criteria:
- Potential participants for the control group will be asked if they have had previous lower limb ailments or surgery, and if they have they will be excluded. Moreover, the THR participants cannot have had secondary hip replacement due to infection, revision surgery, or a concomitant surgical procedure (i.e., graft). Participants from both groups cannot have had any medical conditions which could affect physical movement such as a stroke.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lateral approach
Lateral approach Intervention: Motion Analysis.
Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory
|
Motion analysis will be administered to each of the three groups: Lateral approach, anterior approach and posterior approach
|
Active Comparator: Anterior approach
Anterior approach Intervention: Motion Analysis.
Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory
|
Motion analysis will be administered to each of the three groups: Lateral approach, anterior approach and posterior approach
|
Active Comparator: Posterior approach
Posterior approach Intervention: Motion Analysis.
Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory
|
Motion analysis will be administered to each of the three groups: Lateral approach, anterior approach and posterior approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Joint mechanics of people having undergone total hip replacement
Time Frame: 6-18 months post surgery
|
3D joint mechanics of the lower extremities during level walking, stair ascent and descent, and entering and exiting the front seat of the car
|
6-18 months post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paul E Beaule, MD, FRCSC, University of Ottawa / The Ottawa Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2007
Primary Completion (Estimated)
April 28, 2024
Study Completion (Estimated)
April 28, 2024
Study Registration Dates
First Submitted
April 21, 2008
First Submitted That Met QC Criteria
April 21, 2008
First Posted (Estimated)
April 23, 2008
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 2, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-390
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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