ArCom® and ArComXL® Polyethylene Data Collection - Full Text View

Sponsored by:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00565786

Purpose

The purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will be collated and used as a part of Biomet's post-market surveillance system and to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K926107 and 510(k) K043051. Surgical techniques and patient care are to be standard for the surgeons participating in the protocol.

Condition	Intervention
Arthroplasty, Replacement, Hip	Device: ArCom® Polyethylene Device: ArComXL® Polyethylene

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Polyethylene wear rates [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Harris Hip Score UCLA Activity Score [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	150
Study Start Date:	July 2004
Estimated Study Completion Date:	March 2017

Groups/Cohorts	Assigned Interventions
A	Device: ArCom® Polyethylene Argon packaged compression molded polyethylene
B	Device: ArComXL® Polyethylene Highly crosslinked Ultra High Molecular Weight Polyethylene

Detailed Description:

The study follow-up intervals are 6 weeks, 1 year, 2 years, 3 years, 5 years, and 10 years. Demographic data is collected pre-operatively along with the Harris Hip Score and UCLA Activity Score. Operative information includes the surgical technique and other standard operative information. Follow-up information includes the Harris Hip Score, UCLA Activity Score, and Radiographic data. Anterior/posterior and frog leg lateral X-ray data is recorded to show radiolucencies, component position and angles. Sites are also required to send in an Anterior/Posterior Pelvis x-ray for wear analysis. Implant durability is documented by asking the surgeon to record revisions, complications, and device related adverse events. All information collected is de-identified in compliance with HIPAA regulations.

Eligibility

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

Study Population

The study population will include patients requiring total hip replacement.

Criteria

Inclusion Criteria:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Revision of previously failed total hip arthroplasty

Exclusion Criteria:

Infection
Sepsis
Osteomyelitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565786

Locations

United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46582

Sponsors and Collaborators

Biomet Orthopedics, LLC

Investigators

Principal Investigator:

Ken Beres, MD

Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, LLC ( Ken Beres, MD )
Study ID Numbers:	083-U-003
Study First Received:	November 28, 2007
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00565786 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 07, 2009