A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Verified by: Biomet, Inc., August 2011
First Received: June 13, 2008 | Last Updated: August 23, 2011 | Phase: N/A | Start Date: January 2006
Overall Status: Active, not recruiting | Estimated Enrollment: 149
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The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked...

Brief Summary

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: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: April 2018

Arms, Groups and Cohorts in this Clinical Trial

  • : ArComXL® polyethylene
    • ArComXL® polyethylene

Outcome Measures for this Clinical Trial

Primary Measures

  • Incidence of revisions and removals assessed by the use of a yearly survey mail to patient
    • Time Frame: 5 years
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Biomet Orthopedics, LLC Industry

Overall Clinical Trial Officials and Contacts

Russell Schenck, PhD Study Director Clinical Research, Biomet Orthopedics, Inc.  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00698152