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

N/ATerminatedNCT01420237

Stryker Orthopaedics367 enrolled

Overview

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.

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 Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

367

Conditions

Arthroplasty, Replacement, Hip

Interventions

Restoration ADM X3 DeviceDEVICE

Restoration ADM X3 Device in total hip replacement.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (12)

OrthoArizona

Gilbert, Arizona, United States

Arizona Institute for Bone and Joint Disorders

Phoenix, Arizona, United States

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Success Rate

Defined as absence of postoperative femoral head dislocation.

Time frame: 10 years postoperative

Secondary Outcomes

Harris Hip Score (HHS) Score Improvement From Preoperative Score

The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor

Time frame: pre-op, 6 week, 1,2,3,4,5 years. 7 and 10 years were optional.

All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System

Revision or removal of any study component.

Time frame: 10 years

Patient Satisfaction and Pain: Follow-up Questionnaire

This questionnaire will be used to obtain the following information: * Satisfaction with the hip replacement * Presence of any pain in the study hip * Surgeries performed on the study hip * Any dislocations in the study hip

Time frame: 6-10 years

Radiographic Stability Rates

Cases that present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones will be considered radiographic failures. All cases were assessed for any migration at the 6 week, 1,2,3,4,5 year time points.

Time frame: 6 week,1, 2, 3, 4, 5 years

Complication Rates for Psoas Impingement and Associated Groin Pain

Reported occurrence of any participant/hip experiencing groin pain or psoas impingement.

Time frame: 10 years

Data from ClinicalTrials.gov

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