ArCom® and ArComXL® Polyethylene Data Collection

Zimmer Biomet

Status: Completed

Conditions: Osteoarthritis of Hip

Treatments: Device: ArCom® Polyethylene; Device: ArComXL® Polyethylene

Study type: Observational

Funder types: Industry

Identifiers

NCT00565786

ORTHO.CR.H011

Details and patient eligibility

About

The purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will be collated and used as a part of Biomet's post-market surveillance system and to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K926107 and 510(k) K043051. Surgical techniques and patient care are to be standard for the surgeons participating in the protocol.

Full description

The study follow-up intervals are 6 weeks, 1 year, 2 years, 3 years, 5 years, and 10 years. Demographic data is collected pre-operatively along with the Harris Hip Score and UCLA Activity Score. Operative information includes the surgical technique and other standard operative information. Follow-up information includes the Harris Hip Score, UCLA Activity Score, and Radiographic data. Anterior/posterior and frog leg lateral X-ray data is recorded to show radiolucencies, component position and angles. Sites are also required to send in an Anterior/Posterior Pelvis x-ray for wear analysis. Implant durability is documented by asking the surgeon to record revisions, complications, and device related adverse events. All information collected is de-identified in compliance with HIPAA regulations.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• Revision of previously failed total hip arthroplasty

Exclusion criteria

• Infection
• Sepsis
• Osteomyelitis

Trial design

150 participants in 2 patient groups

ArCom® Polyethylene

Description:

ArCom® Polyethylene

Treatment:

Device: ArCom® Polyethylene

ArComXL® Polyethylene

Description:

ArComXL® Polyethylene

Treatment:

Device: ArComXL® Polyethylene