A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Zimmer Biomet149 enrolled

Overview

The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene

Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected. This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Study Type

OBSERVATIONAL

Enrollment

149

Conditions

Osteoarthritis Avascular Necrosis Rheumatoid Arthritis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid Arthritis * Correction of Functional Deformity * Treatment of non-union, femoral neck fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * Revision of previously failed total hip arthroplasty * Uncemented applications Exclusion Criteria: Absolute contraindications * Infection, sepsis and osteomyelitis Relative contraindications * Uncooperative patient or patient with neurologic disorders who are incapable of following directions * Osteoporosis * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infections which may be spread to the implant site * Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy or neuromuscular disease

Locations (5)

The Orthopaedic Center

Rockville, Maryland, United States

The Orthopaedic Institute of Ohio

Lima, Ohio, United States

Ohio Valley Orthopedic and Sports Medicine

West Chester, Ohio, United States

Scranton Orthopaedic Specialists, PC

Dickson City, Pennsylvania, United States

Outcomes

Primary Outcomes

Incidence of revisions and removals

Patient questionnaire

Time frame: Annually through 10 years

Data from ClinicalTrials.gov

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