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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: May 12, 2014
Last verified: November 2013

November 28, 2007
May 12, 2014
July 2004
November 2016   (final data collection date for primary outcome measure)
Polyethylene wear rates [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00565786 on ClinicalTrials.gov Archive Site
Harris Hip Score UCLA Activity Score [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ArCom® and ArComXL® Polyethylene Data Collection
A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The study population will include patients requiring total hip replacement.

Osteoarthritis of Hip
  • Device: ArCom® Polyethylene
    Argon packaged compression molded polyethylene
  • Device: ArComXL® Polyethylene
    Highly crosslinked Ultra High Molecular Weight Polyethylene
  • ArCom® Polyethylene
    ArCom® Polyethylene
    Intervention: Device: ArCom® Polyethylene
  • ArComXL® Polyethylene
    ArComXL® Polyethylene
    Intervention: Device: ArComXL® Polyethylene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
March 2017
November 2016   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00565786
083-U-003
No
Biomet, Inc. ( Biomet Orthopedics, LLC )
Biomet Orthopedics, LLC
Not Provided
Principal Investigator: Russell Schenck, PhD Biomet Orthopedics, LLC
Biomet, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP