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 range18 Years

SexALL

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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
✕. Patient has a burn affecting greater than or equal to 20% of the total body surface area or on the affected elbow
✕. Patient has pre-existing heterotopic ossification in the affected elbow.
✕. Patient is pregnant.

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