A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Zimmer Biomet

Status: Completed

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT00698152

ORTHO.CR.H012

Details and patient eligibility

About

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

Full description

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.

Enrollment: 149 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

149 participants in 1 patient group

ArComXL® polyethylene

Description:

ArComXL® polyethylene