TerminatedNot Applicable

Ascension PyroCarbon Radial Head Study

Stopped: Business Decision

United States78 participantsStarted 2009-01

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The proportion of patient successes with the Carbon Modular Radial Head vs patient successes with the Metal Radial Head as assessed by implant survival

Timeframe: 2 years

Trial details

NCT IDNCT02405234

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03

View on ClinicalTrials.gov More Degenerative Arthritis trials