TerminatedNot Applicable

HO Prophylaxis Therapy for Distal Humerus Fractures

Stopped: Difficulty getting radiation therapy for patients and Low enrollment number

United States3 participantsStarted 2019-10-09

Plain-language summary

To determine the effectiveness of 500 cGy dose of radiation therapy vs. an untreated group in the prophylactic treatment of heterotopic ossification in distal humerus fractures

Who can participate

Age range

18 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

. Patient has a distal humerus fracture.
. Patient's age is greater than or equal to 18

Exclusion criteria

. Patient has a concomitant proximal ulna and/or proximal radius fracture
. Patient requires external fixation of the elbow
. Patient has quadriplegia or paraplegia
. Patient requires intubation upon admission or for \>4 hours during admission for nonsurgical purposes
. Patient has concomitant soft tissue damage in the affected elbow that cannot be appropriately closed within 72 hours of surgery

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

Number of Participants With Presence of HO on Humerus

Timeframe: 1 year. The control patient completed 366 days of follow up. The two intervention patients lost follow up after 155 days and 62 days.

Trial details

NCT IDNCT03724422

SponsorUniversity of Louisville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-17

Results submitted2021-12-14

View on ClinicalTrials.gov More Heterotopic Ossification trials