Restoration ADM X3 Device for Hip Replacement
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip systems in the literature, through absence of femoral head dislocation at 10 years postoperative.
Research Team
Joseph Nessler, M.D.
Principal Investigator
St. Cloud Orthopedic Associates
Paul Kim, MD
Principal Investigator
The Ottawa Hospital
Amit Atrey, MD
Principal Investigator
Unity Health Toronto
Anthony Hedley, M.D.
Principal Investigator
Arizona Institute for Bone & Joint Disorders
Edward Petrow, DO
Principal Investigator
Tucson Orthopaedic Institute
Kipling Sharpe, M.D.
Principal Investigator
OrthoArizona
Craig J. Della Valle, M.D.
Principal Investigator
Rush University Medical Center
Geoffrey Westrich, MD
Principal Investigator
Hospital for Special Surgery, New York
Brian C de Beaubien, M.D.
Principal Investigator
Covenant Medical Center
Brett Greenky, MD
Principal Investigator
Syracuse Orthopedic Specialists
Ajay Aggarwal, MD
Principal Investigator
Missouri Orthopaedic Institute
Christoph Lohmann, MD
Principal Investigator
Universitatsklinikum Madgeburg A.o.R.
Eligibility Criteria
This trial is for adults aged 18-75 with non-inflammatory degenerative joint disease needing a primary hip replacement. Candidates must be able to follow the study's procedures and not have systemic diseases, severe allergies to device materials, obesity (BMI ≥ 40), infections in the hip, excessive steroid use, prior hip replacements or fusions on the affected joint, or neuromuscular deficiencies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo primary total hip arthroplasty with the Restoration® ADM X3® Acetabular System
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of hip function and stability
Treatment Details
Interventions
- Restoration ADM X3 Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stryker Orthopaedics
Lead Sponsor
Kevin A. Lobo
Stryker Orthopaedics
Chief Executive Officer since 2012
Bachelor's degree in Commerce from McGill University, MBA from University of Toronto
Dr. Jorge Enrique Diaz
Stryker Orthopaedics
Chief Medical Officer since 2023
MD from University of Michigan Medical School