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Mobility Assessment of Patients With Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00664508
Recruitment Status : Active, not recruiting
First Posted : April 23, 2008
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Osteoarthritis Arthroplasty Hip Replacement Procedure: Motion analysis

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparative study with a control group
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mobility Assessment of Patients With Total Hip Arthroplasty: Joint Mechanics and Rehabilitation
Study Start Date : November 2007
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arms and Interventions

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
Procedure: Motion analysis
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
Procedure: Motion analysis
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
Procedure: Motion analysis
Motion analysis will be administered to each of the three groups: Lateral approach, anterior approach and posterior approach


Outcome Measures

Primary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664508


Locations
Canada, Ontario
OHRI
Ottawa, Ontario, Canada, K1Y4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Paul E Beaule, MD, FRCSC University of Ottawa / The Ottawa Hospital
More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00664508     History of Changes
Other Study ID Numbers: 2007-390
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by Ottawa Hospital Research Institute:
Arthroplasty
Hip Replacement
motion analysis

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