A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

This study is ongoing, but not recruiting participants.

First Received: June 13, 2008 Last Updated: December 23, 2008 History of Changes

Sponsored by:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00698152

Purpose

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

Condition
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis

MedlinePlus related topics: Osteoarthritis Osteonecrosis Rheumatoid Arthritis

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

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: 6 weeks, 1 year, 2 years, 3 years, 5 years, 10 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

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)

Groups/Cohorts
ArComXL® polyethylene ArComXL® polyethylene

Eligibility

Study Population

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

Criteria

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

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

Investigators

Study Director:

Kenneth J Beres, MD

Clinical Research, Biomet Orthopedics, Inc.

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, LLC ( Kenneth Beres, MD Director Clinical Research )
Study ID Numbers:	Biomet 12380-326
Study First Received:	June 13, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00698152 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Total Hip Arthroplasty
Total Hip Replacement
Hip Arthritis
Polyethylene

Study placed in the following topic categories:

Necrosis
Autoimmune Diseases
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Osteonecrosis
Immune System Diseases
Osteoarthritis
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Bone Diseases
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 07, 2009