CMRH: Ascension PyroCarbon Radial Head Study

Sponsor

Smith & Nephew, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02405234

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

19.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2009

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

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 Names: 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 Names: Ascension MRH

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 Names:

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 Names:

Ascension MRH

Outcome Measures

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 [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Florida Orthopedic and Rehabilitation	Gainesville	Florida	United States	32611
2	Hand Center of Southwestern Ohio	Dayton	Ohio	United States	45405
3	The Rothman Institute	Philadelphia	Pennsylvania	United States	19107
4	Texas Orthopedic Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

Smith & Nephew, Inc.

Investigators

Study Director: Andrew Tummon, Integra Life Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Smith & Nephew, Inc.

ClinicalTrials.gov Identifier:

NCT02405234

Other Study ID Numbers:

CP-RH-002
NCT00825409

First Posted:

Apr 1, 2015

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2017

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Smith & Nephew, Inc.

Radial Head Arthroplasty

Additional relevant MeSH terms:

Arthritis

Osteoarthritis

Study Results

No Results Posted as of Aug 11, 2022