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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: ADM/MDM hip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ADM/MDM hip prosthesis<br>Type of prosthesis participant received. | Device: ADM/MDM hip<br>* Dual Mobility Hip prosthesis manufactured by Stryker Orthopaedics: ADM/MDM<br>* Other names: Dual Mobility Hip;|

What is the study measuring?
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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 | 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 | 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 |