Official Title: “A Prospective, Non-Controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement”

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

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: April 2018

Arms, Groups and Cohorts in this Clinical Trial

• : ArComXL® polyethylene
  • ArComXL® polyethylene

Primary Measures

• Incidence of revisions and removals assessed by the use of a yearly survey mail to patient
  • Time Frame: 6 weeks, 1 year, 2 years, 3 years, 5 years, 10 years
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Kenneth J Beres, MD Study Director Clinical Research, Biomet Orthopedics, Inc.  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698152

Study ID Number: Biomet 12380-326

ClinicalTrials.gov Identifier: NCT00698152

Health Authority: United States: Institutional Review Board