Ascension PyroCarbon Radial Head Study

NCT ID: NCT02405234

Last Updated: 2022-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Degenerative Arthritis; Radial Head Fracture; Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Carbon Modular Radial Head

PyroCarbon Modular Radial Head replacement

Group Type: EXPERIMENTAL

Carbon Modular Radial Head replacement

Intervention Type: DEVICE

'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.

Metal Radial Head

Metal Radial Head replacement

Group Type: ACTIVE_COMPARATOR

Metal Radial Head replacement

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Ascension CMRH; Ascension MRH

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Tummon

Role: STUDY_DIRECTOR

Integra Life Sciences

Locations

University of Florida Orthopedic and Rehabilitation

Gainesville, Florida, United States

Hand Center of Southwestern Ohio

Dayton, Ohio, United States

The Rothman Institute

Philadelphia, Pennsylvania, United States

Texas Orthopedic Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

CP-RH-002

Identifier Type: -

Identifier Source: org_study_id

NCT00825409

Identifier Type: -

Identifier Source: nct_alias