Official Title: “A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene”

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.

Study Type: Observational

Study Design: Other, Prospective

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.

Intervention(s) in this Clinical Trial

• Device: ArCom® Polyethylene
  • Argon packaged compression molded polyethylene
• Device: ArComXL® Polyethylene
  • Highly crosslinked Ultra High Molecular Weight Polyethylene

Arms, Groups and Cohorts in this Clinical Trial

• : A
• : B

Primary Measures

• Polyethylene wear rates
  • Time Frame: Duration of study
    Safety Issue?: No

Secondary Measures

• Harris Hip Score UCLA Activity Score
  • Time Frame: Duration of study
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Ken Beres, MD Principal Investigator Biomet Orthopedics, LLC  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565786

Study ID Number: 083-U-003

ClinicalTrials.gov Identifier: NCT00565786

Health Authority: United States: Food and Drug Administration