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Sponsored by: |
Biomet Orthopedics, LLC |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00565786 |
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.
Condition | Intervention |
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Arthroplasty, Replacement, Hip |
Device: ArCom® Polyethylene Device: ArComXL® Polyethylene |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene |
Enrollment: | 150 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | March 2017 |
Groups/Cohorts | Assigned Interventions |
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A |
Device: ArCom® Polyethylene
Argon packaged compression molded polyethylene
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B |
Device: ArComXL® Polyethylene
Highly crosslinked Ultra High Molecular Weight Polyethylene
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The study population will include patients requiring total hip replacement.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Biomet Orthopedics, LLC ( Ken Beres, MD ) |
Study ID Numbers: | 083-U-003 |
Study First Received: | November 28, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00565786 |
Health Authority: | United States: Food and Drug Administration |