ArCom® and ArComXL® Polyethylene Data Collection
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthroplasty, Replacement, Hip
Intervention: ArCom® Polyethylene (Device); ArComXL® Polyethylene (Device)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Biomet Orthopedics, Inc. Official(s) and/or principal investigator(s):
Ken Beres, MD, Principal Investigator, Affiliation: Biomet Orthopedics, Inc.
Summary
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.
Clinical Details
Official title: A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene
Study design: Other, Prospective
Primary outcome: Polyethylene wear rates
Secondary outcome: Harris Hip Score
UCLA Activity Score
Detailed 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Biomet Orthopedics, Inc., Warsaw, Indiana 46582, United States
Additional Information
Starting date: July 2004
Ending date: March 2017
Last updated: December 20, 2007
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