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

Tracking Information
First Submitted Date  ICMJE November 4, 2014
First Posted Date  ICMJE April 1, 2015
Last Update Posted Date August 9, 2017
Study Start Date  ICMJE January 2009
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ascension PyroCarbon Radial Head Study
Official Title  ICMJE Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Arthritis
  • Radial Head Fracture
  • Rheumatoid Arthritis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Carbon Modular Radial Head
    PyroCarbon Modular Radial Head replacement
    Intervention: Device: Carbon Modular Radial Head replacement
  • Active Comparator: Metal Radial Head
    Metal Radial Head replacement
    Intervention: Device: Metal Radial Head replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 7, 2017)
78
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2015)
203
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02405234
Other Study ID Numbers  ICMJE CP-RH-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Integra LifeSciences Corporation
Study Sponsor  ICMJE Integra LifeSciences Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrew Tummon Integra Life Sciences
PRS Account Integra LifeSciences Corporation
Verification Date August 2017

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