Overview

This trial is active, not recruiting.

Conditions osteoarthritis, avascular necrosis, rheumatoid arthritis
Sponsor Biomet Orthopedics, LLC
Start date January 2006
End date April 2018
Trial size 149 participants
Trial identifier NCT00698152, ORTHO.CR.H012

Summary

The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
ArComXL® polyethylene

Primary Outcomes

Measure
Incidence of revisions and removals assessed by the use of a yearly survey mail to patient
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid Arthritis - Correction of Functional Deformity - Treatment of non-union, femoral neck fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques - Revision of previously failed total hip arthroplasty - Uncemented applications Exclusion Criteria: Absolute contraindications - Infection, sepsis and osteomyelitis Relative contraindications - Uncooperative patient or patient with neurologic disorders who are incapable of following directions - Osteoporosis - Metabolic disorders which may impair bone formation - Osteomalacia - Distant foci of infections which may be spread to the implant site - Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram - Vascular insufficiency, muscular atrophy or neuromuscular disease

Additional Information

Official title A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
Description Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected. This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Biomet, Inc..