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NCT03724422

HO Prophylaxis Therapy for Distal Humerus Fractures

Terminated NA Results posted Last updated 15 February 2022
What this trial tests

NA trial testing Radiation in Heterotopic Ossification in 3 participants. Terminated before completion.

Timeline
9 October 2019
Primary endpoint
17 November 2020
17 November 2020

Quick facts

Lead sponsorUniversity of Louisville
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment3
Start date9 October 2019
Primary completion17 November 2020
Estimated completion17 November 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Louisville

Who can join

18 and older, any sex, with Heterotopic Ossification or Humeral Fractures. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Presence of HO on Humerus Primary · 1 year. The control patient completed 366 days of follow up. The two intervention patients lost follow up after 155 days and 62 days.

Presence of heterotopic ossification on plain radiographs taken in the anteroposterior and lateral planes within 1 year after surgery as quantified using the classification systems described by Brooker, et al. and Hastings and Graham

GroupValue95% CI
Control0
Intervention0
Non-union at the Fracture Site. Secondary · 1 year post surgical reduction. The control patient completed 366 days of follow up. The two intervention patients lost follow up after 155 days and 62 days respectively.

Rate of non-union of both groups requiring revision surgery.

GroupValue95% CI
Control0
Intervention0

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Radiation

Trials testing the same drug.

Other recruiting trials for Heterotopic Ossification

Currently open trials in the same condition.

Other University of Louisville trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03724422.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing