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

Unity Health Toronto

Status: Unknown

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: ADM/MDM hip

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04019925

19-061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

ADM/MDM hip prosthesis

Other group

Description:

Type of prosthesis participant received.

Treatment:

Device: ADM/MDM hip