Osteoarthritis of Hip
Conditions
Brief 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.
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.
Interventions
DEVICEArCom® Polyethylene
Argon packaged compression molded polyethylene
DEVICEArComXL® Polyethylene
Highly crosslinked Ultra High Molecular Weight Polyethylene
Sponsors
Zimmer Biomet
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polyethylene wear rates | 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain, Function, Absence of Deformity, and Range of Motion | Pre-intervention, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year | 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. |
| Physical Activity Level | Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year | Physical Activity Level will be measured using the UCLA Activity Scale. On a scale of 1-10, higher scores mean a better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year | Evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects. |
| Survivorship | Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year | Analyze survivorship using revision or intended revision as an endpoint. |
Countries
United States
Outcome results
None listed