A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
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|
The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene
Incidence of revisions and removals assessed by the use of a yearly survey mail to patient
time frame: 5 years
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
|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.|
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