Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study

Stryker

Status

Terminated

Conditions

Arthroplasty, Replacement, Hip

Treatments

Device: Restoration ADM X3 Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01420237

Details and patient eligibility

About

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.

Full description

This study is a prospective, open-label, post-market, non-randomized, multi-center, clinical evaluation of the Restoration® ADM X3® Acetabular System for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is 350 cases, all of which will receive the Restoration® ADM X3® Acetabular System. A minimum of 100 cases (within the study population) will receive the Accolade® II Hip Stem. The remaining cases will receive any other compatible Stryker femoral component.

Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.

Enrollment

367 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has signed an IRB/EC approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female, skeletally mature and age 18-75 years at time of study device implantation.
Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
Patient is a candidate for a primary cementless acetabular replacement.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion criteria

Patient has a Body Mass Index (BMI) ≥ 40.
Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
Patient has a known sensitivity to device materials.
Patient is a prisoner.