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ArCom® and ArComXL® Polyethylene Data Collection

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00565786
First Posted: November 30, 2007
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )
  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
Osteoarthritis of 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:


Further study details as provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):

Primary Outcome Measures:
  • Polyethylene wear rates [ Time Frame: Duration of study ]

Secondary Outcome Measures:
  • Harris Hip Score UCLA Activity Score [ Time Frame: Duration of study ]

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
ArCom® Polyethylene
ArCom® Polyethylene
Device: ArCom® Polyethylene
Argon packaged compression molded polyethylene
ArComXL® Polyethylene
ArComXL® Polyethylene
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00565786     History of Changes
Other Study ID Numbers: ORTHO.CR.H011
First Submitted: November 28, 2007
First Posted: November 30, 2007
Last Update Posted: August 2, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases