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 HumerusPrimary· 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
Group
Value
95% CI
Control
0
Intervention
0
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.
Group
Value
95% CI
Control
0
Intervention
0
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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Sponsor: as reported to ClinicalTrials.gov by University of Louisville
Last refreshed: 15 February 2022
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.