ArCom® and ArComXL® Polyethylene Data Collection
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/3/2016 |
| Start Date: | July 2004 |
| End Date: | March 2017 |
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.
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.
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.
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
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