367 Participants Needed

Restoration ADM X3 Device for Hip Replacement

Recruiting at 11 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JN

Joseph Nessler, M.D.

Principal Investigator

St. Cloud Orthopedic Associates

PK

Paul Kim, MD

Principal Investigator

The Ottawa Hospital

AA

Amit Atrey, MD

Principal Investigator

Unity Health Toronto

AH

Anthony Hedley, M.D.

Principal Investigator

Arizona Institute for Bone & Joint Disorders

EP

Edward Petrow, DO

Principal Investigator

Tucson Orthopaedic Institute

KS

Kipling Sharpe, M.D.

Principal Investigator

OrthoArizona

CJ

Craig J. Della Valle, M.D.

Principal Investigator

Rush University Medical Center

GW

Geoffrey Westrich, MD

Principal Investigator

Hospital for Special Surgery, New York

BC

Brian C de Beaubien, M.D.

Principal Investigator

Covenant Medical Center

BG

Brett Greenky, MD

Principal Investigator

Syracuse Orthopedic Specialists

AA

Ajay Aggarwal, MD

Principal Investigator

Missouri Orthopaedic Institute

CL

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

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.
See 1 more

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.
See 5 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Restoration ADM X3 DeviceExperimental Treatment1 Intervention
Restoration ADM X3 Device in total hip replacement.

Find a Clinic Near You

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

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