Restoration ADM X3 Device for Hip Replacement

No longer recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Orthopaedics

Must not be taking: Steroids

Disqualifiers: BMI ≥ 40, Infection, Neuromuscular deficiency, Systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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

I have been diagnosed with a type of arthritis that is not caused by inflammation.

I am eligible for a hip socket replacement without cement.

I am willing and able to follow through with all after-surgery check-ups and rehab.

Exclusion Criteria

Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device

Patient has a known sensitivity to device materials

I might have an infection in or near my hip where a device will be implanted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary total hip arthroplasty with the Restoration® ADM X3® Acetabular System

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of hip function and stability

10 years

Regular visits at 6 weeks, 1, 2, 3, 4, 5 years, with optional visits at 7 and 10 years

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?

Group I: Restoration ADM X3 Device Experimental Treatment 1 Intervention

Restoration ADM X3 Device in total hip replacement.

Who Is Running the Clinical Trial?

Stryker Orthopaedics

Lead Sponsor

Trials

79

Recruited

20,500+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01420237

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6920720/

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=results

Study 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.

4. cureus.com cureus.com/articles/260383-comparison-of-outcomes-in-dual-mobility-versus-fixed-bearing-implants-in-primary-total-hip-arthroplasty-a-systematic-review-and-meta-analysis

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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7393448/

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=JDI

MAUDE 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.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104673

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.pdf

Restoration 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 ...

9. cdn.stryker.com cdn.stryker.com/SYKGCSDOC-2-42928

ADM® X3® Mobile Bearing Hip® System Contraindications. 1 . Overt infection;. 2 . Distant foci of infections (which may cause hematogenous spread to the implant site);.