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Radiation Therapy for Heterotopic Ossification
N/A
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Indicated for surgical fixation via a posterior or combined anterior and posterior approach
Adult aged 18+ with an acute acetabular fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of surgery
Awards & highlights
Study Summary
This trial is testing whether radiation works better than no treatment in preventing the formation of abnormal bone after surgery on the acetabulum.
Who is the study for?
This trial is for adults over 18 with a recent acetabular fracture (hip socket fracture) needing surgery. They must live in Maryland and be able to return for follow-ups, speak English, and not have contraindications to radiation like a history of cancer or previous radiotherapy.Check my eligibility
What is being tested?
The study is testing if external beam radiation (XRT) given within 3 days after hip surgery can prevent abnormal bone growth compared to no treatment. It aims to provide high-quality evidence on the effectiveness of this preventive measure.See study design
What are the potential side effects?
Potential side effects from external beam radiation may include skin irritation at the treatment site, fatigue, mild swelling or pain in treated area. These are generally temporary but vary between individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am recommended for surgery that involves accessing the area from the back or both front and back.
Select...
I am an adult with a recent hip socket fracture.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 hours of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Consent rate
Secondary outcome measures
Comparison of HO formation by HO prophylaxis type (XRT vs no treatment)
Comparison of severe HO formation by HO prophylaxis type (XRT vs no treatment)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: External Beam Radiation (XRT) with DebridementExperimental Treatment2 Interventions
Patients will receive gluteus minimus debridement in the OR, which is the standard of care at Shock Trauma. If randomized to the treatment group, patients that undergo surgical fixation of an acetabular fracture via a posterior or combined anterior and posterior approach will undergo a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery. This treatment is currently the standard procedure performed for all patients who undergo a posterior or combined approach at our institution.
Group II: Debridement Alone (Control)Active Control1 Intervention
The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Debridement
2018
Completed Phase 4
~100
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,586 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am getting a hip replacement during my hip fracture repair surgery.I do not speak English.I cannot receive radiotherapy due to a past cancer treatment.I am recommended for surgery that involves accessing the area from the back or both front and back.I am an adult with a recent hip socket fracture.
Research Study Groups:
This trial has the following groups:- Group 1: External Beam Radiation (XRT) with Debridement
- Group 2: Debridement Alone (Control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for enrollment in this current clinical trial?
"According to the clinicaltrials.gov registry, recruitment for this trial has been terminated; it was first posted in May 2021 and last modified on February 2022. Nonetheless, currently 4 other trials are accepting participants."
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