A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
First received: June 13, 2008
Last updated: October 30, 2013
Last verified: October 2013

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

Avascular Necrosis
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Resource links provided by NLM:

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Incidence of revisions and removals assessed by the use of a yearly survey mail to patient [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 149
Study Start Date: January 2006
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
ArComXL® polyethylene
ArComXL® polyethylene


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that have already made the decision to undergo Total Hip Replacement and will recieve ArComXL® polyethylene


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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698152

Sponsors and Collaborators
Biomet Orthopedics, LLC
Study Director: Russell Schenck, PhD Clinical Research, Biomet Orthopedics, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00698152     History of Changes
Other Study ID Numbers: Biomet 12380-326
Study First Received: June 13, 2008
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Total Hip Arthroplasty
Total Hip Replacement
Hip Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on April 23, 2014