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Ascension PyroCarbon Radial Head Study (CMRH)

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. Identifier: NCT02405234
Recruitment Status : Terminated (Business Decision)
First Posted : April 1, 2015
Last Update Posted : August 9, 2017
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Brief Summary:
The proportion of patient successes with the Carbon Modular Radial Head at the 2-year evaluation is no lower than the proportion of patient successes with the Metal Radial Head.

Condition or disease Intervention/treatment Phase
Degenerative Arthritis Radial Head Fracture Rheumatoid Arthritis Device: Carbon Modular Radial Head replacement Device: Metal Radial Head replacement Not Applicable

Detailed Description:

This investigation will include 179 patients (119 study devices and 60 control devices) enrolled at 15 active centers. In addition a subset of 24 RA patients will be enrolled and analyzed separately. The trial is designed as a randomized, non-inferiority study comparing results of the CMRH to results of the MRH.

This will be a multi-site study with all patients either receiving the CMRH or the MRH. Sequential enrollment of all patients meeting inclusion criteria and agreeing to be in the study will be enrolled. The patients will sign an informed consent agreeing to accept either the investigational or control device. In addition, the surgeon will not know which device the patient is to receive until the day of surgery in an attempt to further reduce bias. The surgeon will open an envelope at the time of surgery to determine if a CMRH or MRH will be implanted.

Additional efforts to eliminate bias in the study will include a final radiographic analysis by an independent observer experienced in reporting on orthopedic devices. The independent reviewer will grade the surgical implant and determine radiographic success/failure for each patient.

Implants will be assigned to patients at the clinical sites in a block randomization fashion. The randomization will be site specific. At a given site, each consecutive block of six enrolled patients to be treated will receive random assignments of CMRH or MRH at a 2:1. The randomization schedule is generated by computer (NQuery) and is produced in blocks of 6, where 4 are study devices and 2 are control devices.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head
Study Start Date : January 2009
Actual Primary Completion Date : March 2015
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Carbon Modular Radial Head
PyroCarbon Modular Radial Head replacement
Device: Carbon Modular Radial Head replacement
'Carbon Modular Radial Head replacement: The Ascension Radial Head is made of pyrocarbon, a material that testing has shown to be both wear resistant and biocompatible and has been used in surgical implants for years. The introduction of the pyrocarbon head should alleviate the problems associated with wear debris and fragmentation experienced with the silicone radial spacer.
Other Name: Ascension CMRH

Active Comparator: Metal Radial Head
Metal Radial Head replacement
Device: Metal Radial Head replacement
Metal Radial Head replacement:The Ascension® Modular Radial Head (MRH) is an anatomically designed, single-use, modular prosthesis designed for replacement of the proximal end of the radius. FDA cleared this device for commercial distribution under 510(k) K032686. It is made from medical grade cobalt chromium alloy meeting ASTM F1537. Head components are available in six sizes and stem components are available in four sizes are interchangeable and assembled with a taper connection.
Other Name: Ascension MRH

Primary Outcome Measures :
  1. The proportion of patient successes with the Carbon Modular Radial Head vs patient successes with the Metal Radial Head as assessed by implant survival [ Time Frame: 2 years ]

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.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must need a radial head replacement for:

    • Degenerative, post-traumatic or rheumatoid arthritis
    • Primary replacement after fracture of the radial head
    • Relief of symptoms after radial head resection
    • Revision of failed radial head arthroplasty
    • Skeletally mature individuals ages 18 - 85

Exclusion Criteria:

  • Inadequate bone stock or soft tissue coverage
  • Previous open fracture or infection in the joint
  • Individuals under age of 18 or over 85 years of age
  • Physical interference with or by other prostheses during implantation or use
  • Procedures requiring modification of the prosthesis
  • Skin, bone, circulatory and/or neurological deficiency at the implantation site
  • Prisoners
  • Patients on chronic corticosteroid or non-steroidal anti-inflammatory therapy

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 identifier (NCT number): NCT02405234

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United States, Florida
University of Florida Orthopedic and Rehabilitation
Gainesville, Florida, United States, 32611
United States, Ohio
Hand Center of Southwestern Ohio
Dayton, Ohio, United States, 45405
United States, Pennsylvania
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Texas Orthopedic Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Integra LifeSciences Corporation
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Study Director: Andrew Tummon Integra Life Sciences
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Responsible Party: Integra LifeSciences Corporation Identifier: NCT02405234    
Obsolete Identifiers: NCT00825409
Other Study ID Numbers: CP-RH-002
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Keywords provided by Integra LifeSciences Corporation:
Radial Head Arthroplasty
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases