Assessing the Wear Rates of the ADM/MDM Hips Using 3D X-ray Analysis

July 12, 2019 updated by: Unity Health Toronto

Assessing the Wear Rates of the ADM/MDM Dual Mobility Hips Manufactured by Stryker Orthopaedics Using 3D X-ray Analysis

A common complication post hip replacement is hip dislocation or hip instability which can lead to the hip implants being revised. A new generation of Dual Mobility hips was designed to minimize hip dislocation/hip instability and polyethylene wear thus increasing the longevity of the hip prosthesis and reducing the number of re-operations for a patient. In this study we will be assessing 2 dual mobility hips manufactured by Stryker Orthopaedics Inc. The ADM and the MDM.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hip replacement is a procedure in which the hip joint is replaced by a prosthetic implant or prosthesis. Post op hip dislocation or hip instability is a common complication which can lead to the hip implants being revised. There are many types of hip prostheses manufactured with the aim of prolonging longevity of the prosthesis and minimizing postoperative complications. One of these is a new generation of dual mobility hip manufactured by Stryker Orthopaedics. The Anatomic Dual Mobility (ADM) and the Modular Dual Mobility (MDM) were designed to minimize hip dislocation/hip instability and polyethylene wear thus increasing the longevity of the hip prosthesis and reducing the number of re-operations for a patient. In this study we will be assessing the outcome of the ADM and MDM hip system.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact

  • Name: Kerry Ann K. Griffith-Cunningham
  • Phone Number: 2273 416 864-6060
  • Email: griffithk@smh.ca

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Unity Health Toronto, St. Michael's Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or non-pregnant female
  • Skeletally mature
  • 18 to 75 years old
  • Stryker Dual Mobility Hip prosthesis
  • BMI between 20 and 35
  • Follow-up x-rays between 3 years and 6 years postop

Exclusion Criteria:

  • Dual Mobility Hip implant that is not the ADM or MDM
  • BMI that is 19 or less
  • BMI that is greater than 36
  • Most recent x-rays less than 3 years postop

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ADM/MDM hip prosthesis
Type of prosthesis participant received.
Device: ADM/MDM hip
Dual Mobility Hip prosthesis manufactured by Stryker Orthopaedics: ADM/MDM
Other Names:
  • Dual Mobility Hip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the change in polyethylene wear of Dual Mobility hip implants using Stryker Orthopaedics ADM & MDM prostheses
Time Frame: before the patient's discharge home, 6 weeks postop, and the most recent x-ray taken up to 5 years postop.
This study will assess the change in linear and volumetric wear using 3D x-ray analysis. Measurements will be taken of x-rays obtained before the patient's discharge home, 6 weeks postop, and the most recent x-ray taken more than 3 years postop.
before the patient's discharge home, 6 weeks postop, and the most recent x-ray taken up to 5 years postop.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To review the number of postop hip dislocations/hip instabilities
Time Frame: first 5 years post surgery
Dislocations and the post op time for each occurrence per patient will be collected in tabular format. This in turn will be used to calculate percent of cases/subject.
first 5 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Stryker Orthopaedics

Investigators

  • Principal Investigator: Amit Atrey, MD, Unity Health Toronto, St. Michael's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

March 30, 2020

Study Completion (Anticipated)

August 31, 2020

Study Registration Dates

First Submitted

July 3, 2019

First Submitted That Met QC Criteria

July 12, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 19-061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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