This trial is active, not recruiting.

Condition osteoarthritis of hip
Treatments arcom® polyethylene, arcomxl® polyethylene
Sponsor Biomet Orthopedics, LLC
Start date July 2004
End date November 2016
Trial size 150 participants
Trial identifier NCT00565786, ORTHO.CR.H011


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective
ArCom® Polyethylene
arcom® polyethylene
Argon packaged compression molded polyethylene
ArComXL® Polyethylene
arcomxl® polyethylene
Highly crosslinked Ultra High Molecular Weight Polyethylene

Primary Outcomes

Polyethylene wear rates
time frame: Duration of study

Secondary Outcomes

Harris Hip Score UCLA Activity Score
time frame: Duration of study

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene
Principal investigator Russell Schenck, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Biomet, Inc..