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Mobility Assessment of Patients With Total Hip Arthroplasty

Primary Purpose

Osteoarthritis, Arthroplasty, Hip Replacement

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Motion analysis

About this trial

This is an interventional other trial for Osteoarthritis focused on measuring Arthroplasty, Hip Replacement, motion analysis

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

OHRI

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Lateral approach

Anterior approach

Posterior approach

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Joint mechanics of people having undergone total hip replacement

3D joint mechanics of the lower extremities during level walking, stair ascent and descent, and entering and exiting the front seat of the car

Secondary Outcome Measures

Full Information

NCT ID

NCT00664508

First Posted

April 21, 2008

Last Updated

February 4, 2020

Sponsor

Ottawa Hospital Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT00664508

Brief Title

Mobility Assessment of Patients With Total Hip Arthroplasty

Official Title

Mobility Assessment of Patients With Total Hip Arthroplasty: Joint Mechanics and Rehabilitation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (Actual)

Primary Completion Date

August 31, 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Arthroplasty, Hip Replacement

Keywords

Arthroplasty, Hip Replacement, motion analysis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Comparative study with a control group

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lateral approach

Arm Type

Active Comparator

Arm Description

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

Arm Title

Anterior approach

Arm Type

Active Comparator

Arm Description

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

Arm Title

Posterior approach

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Motion analysis

Intervention Description

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

Primary Outcome Measure Information:

Title

Joint mechanics of people having undergone total hip replacement

Description

3D joint mechanics of the lower extremities during level walking, stair ascent and descent, and entering and exiting the front seat of the car

Time Frame

6-18 months post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul E Beaule, MD, FRCSC

Organizational Affiliation

University of Ottawa / The Ottawa Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

OHRI

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y4E9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Mobility Assessment of Patients With Total Hip Arthroplasty

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