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

Not Applicable

• Conditions: Arthroplasty, Replacement, Hip
• Interventions: Device: ADM/MDM hip

• Registration Number: NCT04019925
• Lead Sponsor: Unity Health Toronto

Brief Summary

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.

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 Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-12
• Last Update Submitted: 2019-07-12
• Study First Posted: 2019-07-15
• Last Update Posted: 2019-07-15
• Study Start: 2019-09-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADM/MDM hip prosthesis	ADM/MDM hip	Type of prosthesis participant received.

Primary Outcome Measures

Name	Time	Method
To assess the change in polyethylene wear of Dual Mobility hip implants using Stryker Orthopaedics ADM & MDM prostheses	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.

Secondary Outcome Measures

Name	Time	Method
To review the number of postop hip dislocations/hip instabilities	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.

Trial Locations

Locations (1)

Unity Health Toronto, St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada