ArCom® and ArComXL® Polyethylene Data Collection

Completed

Conditions studied: Osteoarthritis of Hip

In brief

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.

Key facts

Study ID

NCT00565786

Run by

Zimmer Biomet

People needed

150

Starts

2004-07-01

Expected to finish

2020-01-13

Last updated by the study team

2025-06-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Infection
• Sepsis
• Osteomyelitis

Where it is running

• Joint Implant Surgeons, Inc. — New Albany, Ohio, United States
• Texas Center for Joint Replacement — Plano, Texas, United States
• The Kennedy Center for the Hip & Knee — Oshkosh, Wisconsin, United States

Full record on ClinicalTrials.gov

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