Ascension PyroCarbon Radial Head Study (CMRH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Integra LifeSciences Corporation
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT02405234
First received: November 4, 2014
Last updated: March 27, 2015
Last verified: March 2015
  Purpose

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 Intervention
Degenerative Arthritis
Radial Head Fracture
Rheumatoid Arthritis
Device: Carbon Modular Radial Head replacement
Device: Metal Radial Head replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 203
Study Start Date: January 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02405234

Contacts
Contact: Chris Ward, MS, CCRP 5128523938 christopher.ward@integralife.com
Contact: Candi Langmaid 5128523935 candi.langmaid@integralife.com

Locations
United States, Florida
University of Florida Orthopedic and Rehabilitation Recruiting
Gainesville, Florida, United States, 32611
Contact: Aimee Struk    352-273-7419    strukam@ortho.ufl.edu   
Principal Investigator: Thomas Wright, MD         
United States, Ohio
Hand Center of Southwestern Ohio Active, not recruiting
Dayton, Ohio, United States, 45405
United States, Pennsylvania
The Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Thema Nicholson, MS    267-339-3615    Thema.Nicholson@rothmaninstitute.com   
Principal Investigator: Charles Getz, MD         
United States, Texas
Texas Orthopedic Hospital Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
Study Director: Candi Langmaid Integra Life Sciences
  More Information

No publications provided

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT02405234     History of Changes
Obsolete Identifiers: NCT00825409
Other Study ID Numbers: CP-RH-002
Study First Received: November 4, 2014
Last Updated: March 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Integra LifeSciences Corporation:
Radial Head Arthroplasty

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 03, 2015