MedTrace Logo

Ascension PyroCarbon Radial Head Study

NCT02405234 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-08-11

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Tummon · Integra Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-03-31
Completion
2017-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02405234 on ClinicalTrials.gov