Clinical trial NCT04019925: Assessing the Wear Rates of the ADM/MDM Hips Using 3D X-ray Analysis
Official title: Assessing the Wear Rates of the ADM/MDM Dual Mobility Hips Manufactured by Stryker Orthopaedics Using 3D X-ray Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2019-07-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the change in polyethylene wear of Dual Mobility hip implants using Stryker Orthopaedics ADM & MDM prostheses
timeFrame: before the patient's discharge home, 6 weeks postop, and the most recent x-ray taken up to 5 years postop.
Secondary outcomes:
measure: To review the number of postop hip dislocations/hip instabilities
timeFrame: first 5 years post surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto, St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto, St. Michael's Hospital
name: Amit Atrey, MD
role: PRINCIPAL_INVESTIGATOR
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