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.
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.
Study Type
OBSERVATIONAL
Enrollment
150
Argon packaged compression molded polyethylene
Highly crosslinked Ultra High Molecular Weight Polyethylene
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
Polyethylene wear rates
Independent wear analysis of radiographs. The six-week radiographic evaluation will be assessed in comparison to the one-year evaluation in order to determine the early changes of the polyethylene. The difference between the one and two-year evaluations will yield the first true wear rate. We have included a three-year evaluation to reduce the scatter of the linear regression used to calculate the wear rate. The five-year and ten-year evaluations will produce mid and long-term wear rates.
Time frame: 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Pain, Function, Absence of Deformity, and Range of Motion
Pain, Function, Absence of Deformity, and Range of Motion will be measured using the Harris Hip Score. On a scale of 0-100, higher scores mean a better outcome.
Time frame: Pre-intervention, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Physical Activity Level
Physical Activity Level will be measured using the UCLA Activity Scale. On a scale of 1-10, higher scores mean a better outcome.
Time frame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
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