An observational study in Osteoarthritis of Hip, sponsored by Zimmer Biomet. Completed at 3 sites in United States. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Zimmer Biomet · Observational
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.
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's enrollment of 150 is close to the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Zimmer Biomet is the lead sponsor of 271 studies on the registry; 28 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include patients requiring total hip replacement.
Exclusion Criteria:
ArCom® Polyethylene
Device: ArCom® Polyethylene
ArComXL® Polyethylene
Device: ArComXL® Polyethylene
Argon packaged compression molded polyethylene
Highly crosslinked Ultra High Molecular Weight Polyethylene
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
Adverse Event
Evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Time frame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Survivorship
Analyze survivorship using revision or intended revision as an endpoint.
Time frame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Zimmer Biomet