Restoration ADM X3 Device for Hip Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the effectiveness of the Restoration ADM X3 hip replacement device in preventing hip joint dislocation over ten years. It focuses on individuals with Non-Inflammatory Degenerative Joint Disease, a type of arthritis that wears down cartilage, who require a primary hip replacement without cement. Candidates with this condition who can manage regular follow-ups and rehabilitation may be suitable for the trial. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance future hip replacement outcomes.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Restoration ADM X3 Device is safe for hip replacement?
Research has shown that the Restoration ADM X3 Device is generally safe for hip replacements. The device's history shows it was made without reported issues, suggesting it meets safety standards. However, a Class 2 recall has occurred for this device, indicating potential temporary health problems, though serious harm is unlikely. Despite some concerns, the device has helped individuals regain mobility and reduce pain after hip replacement surgery. For any safety concerns, consult your doctor.12345
Why are researchers excited about this trial?
The Restoration ADM X3 Device is unique because it offers an innovative approach to hip replacement. Unlike standard metal or ceramic implants, this device uses advanced materials designed to enhance durability and reduce wear over time. Researchers are excited about this treatment because it aims to extend the lifespan of hip replacements, potentially reducing the need for revision surgeries. Additionally, its design may improve joint mobility and patient comfort, making it a promising option for those undergoing hip replacement surgery.
What evidence suggests that the Restoration ADM X3 Device is effective for hip replacement?
Research has shown that the Restoration ADM X3 Device used in hip replacements is promising. Studies have found that this device has a lower risk of dislocation and requires fewer follow-up surgeries compared to other hip systems. A review of multiple studies indicates that devices like the ADM X3 help maintain hip replacement stability. In a study involving several centers, patients with ADM cups reported good results with no dislocations over five years. This suggests that the Restoration ADM X3 Device could be a reliable option for hip replacement surgeries.36789
Who Is on the 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.
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Restoration ADM X3 Device
Trial Overview
The study tests how well a new type of cementless hip replacement device called Restoration ADM X3 works by checking if it prevents dislocation of the femoral head within ten years after surgery compared to other devices documented in medical literature.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Restoration ADM X3 Device in total hip replacement.
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
Citations
Restoration® Anatomic Dual Mobility (ADM) X3® ...
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 ...
Anatomic dual mobility compared to modular ...
Dual mobility (DM) has been used in primary total hip arthroplasty recently for their low dislocation rates, low revision rates, and improved ...
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT01420237?term=restoration%20adm&viewType=Table&rank=1&tab=resultsStudy Results | Restoration® Anatomic Dual Mobility (ADM ...
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
A Systematic Review and Meta-Analysis
Comparison of Outcomes in Dual-Mobility Versus Fixed-Bearing Implants in Primary Total Hip Arthroplasty: A Systematic Review and Meta-Analysis.
Five-Year Follow-Up of Clinical Outcomes with an ...
In this multicenter study of ADM cups used in primary total hip arthroplasty, we demonstrated good clinical and radiographic outcomes, no dislocations, and no ...
6.
accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20230877&pc=JDIMAUDE Adverse Event Report: STRYKER ORTHOPAEDICS ...
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.
Class 2 Device Recall Restoration ADM System X3 ...
Class 2 Device Recall Restoration ADM System X3 Acetabular Insert ; Manufacturer Reason for Recall ; FDA Determined Cause ; Action, The firm, Stryker, sent an " ...
8.
stryker.com
stryker.com/content/dam/stryker/ifus/canada/Restoration%20ADM%20QIN%204400%20Rev%20AB.pdfRestoration ADM
The advancement of partial and total hip replacement has provided the surgeon with a means of restoring mobility and reducing pain with the use of implanted ...
ADM® X3® Mobile Bearing Hip® System
Contraindications. 1 . Overt infection;. 2 . Distant foci of infections (which may cause hematogenous spread to the implant site);.
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