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 range

18 Years – 85 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

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