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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ArCom® Polyethylene | ArCom® Polyethylene |
| |
| ArComXL® Polyethylene | ArComXL® Polyethylene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ArCom® Polyethylene | Device | Argon packaged compression molded polyethylene |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects. | Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year |
| Survivorship |
Inclusion Criteria:
Exclusion Criteria:
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The study population will include patients requiring total hip replacement.
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| Name | Affiliation | Role |
|---|---|---|
| Kacy Arnold, MBA | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Implant Surgeons, Inc. | New Albany | Ohio | 43054 | United States | ||
| Texas Center for Joint Replacement |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ArComXL® Polyethylene |
| Device |
Highly crosslinked Ultra High Molecular Weight Polyethylene |
|
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 |
Analyze survivorship using revision or intended revision as an endpoint.
| Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year |
| Plano |
| Texas |
| 75093 |
| United States |
| The Kennedy Center for the Hip & Knee | Oshkosh | Wisconsin | 54904 | United States |
| D012216 |
| Rheumatic Diseases |