N/A
N=117
Heterotopic Ossification Prophylaxis
Acetabular Fracture · Heterotopic Ossification
Bottom Line
View on ClinicalTrials.gov: NCT04867278 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Severe HO Formation — 3; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- External Beam Radiation (XRT) (Procedure); Debridement (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe HO Formation |
3; 9 | — |
| SECONDARY Number of Participants With Any HO Formation |
10; 17 | — |
Summary
One complication that can occur after surgery on the acetabulum is the development of bone in abnormal places such as muscle and soft tissues. There is some evidence that a single dose of radiation to the surgical site within 3 days of surgery will prevent this abnormal bone from forming. However, there are no high quality studies proving that radiation works any better than doing nothing at all. The purpose of our study is to determine whether there is a difference in abnormal bone formation after acetabular surgery when patients are treated with external beam irradiation versus no treatment.
Eligibility Criteria
Inclusion Criteria
- Adult aged 18+ with an acute acetabular fracture
- Indicated for surgical fixation via a posterior or combined anterior and posterior approach
Exclusion Criteria
- Contraindication to radiotherapy such as history of cancer/RT
- Patients that are getting an acute total hip arthroplasty at the time of fixation of the acetabular fracture
- Not English speaking
- Not a Maryland resident or likely to have difficulty returning for post-op follow up(s) (i.e. homeless, incarceration)
Data sourced from ClinicalTrials.gov (NCT04867278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.