TerminatedNot Applicable

Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma

Stopped: there was an unacceptably high adverse event rate in the treatment group.

48 participantsStarted 2005-09

Plain-language summary

The investigators hypothesized that radiation therapy could be safely administered acutely after elbow trauma, and it would decrease the number of patients that would require surgical excision of heterotopic ossification.

Who can participate

Age range

18 Years – 65 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: * Skeletally mature patients with minimum age of 18 years and maximum age of 65. * Patients deemed appropriate for operative intervention by the treating physician. * Distal humerus intra-articular fractures (types 13-C1, C2, and C3), with or without proximal radius/ulna fractures - open or closed. * Fracture-dislocations of the elbow (ulno-humeral dislocation associated with proximal ulna and/or radius fractures) - open or closed. Exclusion Criteria: * Head injury, quantified by Glasgow Coma Score (GCS) \< 13 at time of consent for operative intervention. * Burns \> 20% Total Body Area (TBA) or involving the operative site. * Patients with spinal cord injury affecting the upper extremities will be excluded. * Open fractures which cannot be closed primarily within 72 hours of initial operative intervention. * Patients with estimated life expectancy of less than one year due to preexisting condition.

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

Mayo Elbow Performance Score

Timeframe: 6 month

Trial details

NCT IDNCT00991887

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2011-04-18

View on ClinicalTrials.gov More Elbow Fracture trials

Who can participate

Age range

18 Years – 65 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.