ArCom® and ArComXL® Polyethylene Data Collection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoarthritis of Hip

Intervention / Treatment
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* Device: ArCom® Polyethylene
* Device: ArComXL® Polyethylene


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ArCom® Polyethylene<br>ArCom® Polyethylene | Device: ArCom® Polyethylene<br>* Argon packaged compression molded polyethylene<br>|
| ArComXL® Polyethylene<br>ArComXL® Polyethylene | Device: ArComXL® Polyethylene<br>* Highly crosslinked Ultra High Molecular Weight Polyethylene<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year |