- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405234
Ascension PyroCarbon Radial Head Study (CMRH)
Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32611
- University of Florida Orthopedic and Rehabilitation
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-
Ohio
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Dayton, Ohio, United States, 45405
- Hand Center of Southwestern Ohio
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- The Rothman Institute
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Texas
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Houston, Texas, United States, 77030
- Texas Orthopedic Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Carbon Modular Radial Head
PyroCarbon 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 Names:
|
ACTIVE_COMPARATOR: Metal Radial Head
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andrew Tummon, Integra Life Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-RH-002
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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