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ArCom® and ArComXL® Polyethylene Data Collection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00565786
First received: November 28, 2007
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

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 ]

Enrollment: 150
Study Start Date: July 2004
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
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: Russell Schenck, PhD Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00565786     History of Changes
Other Study ID Numbers: 083-U-003
Study First Received: November 28, 2007
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 18, 2013