Acetabular Fracture Clinical Trial
Official title:
External Beam Radiotherapy as Prophylaxis for Heterotopic Ossification After Surgical Fixation of Acetabular Fractures: a Prospective, Randomized Feasibility Study
Verified date | August 2023 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland, Shock Trauma Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Burd TA, Lowry KJ, Anglen JO. Indomethacin compared with localized irradiation for the prevention of heterotopic ossification following surgical treatment of acetabular fractures. J Bone Joint Surg Am. 2001 Dec;83(12):1783-8. doi: 10.2106/00004623-200112000-00003. Erratum In: J Bone Joint Surg Am 2002 Jan;84-A(1):100. — View Citation
Karunakar MA, Sen A, Bosse MJ, Sims SH, Goulet JA, Kellam JF. Indometacin as prophylaxis for heterotopic ossification after the operative treatment of fractures of the acetabulum. J Bone Joint Surg Br. 2006 Dec;88(12):1613-7. doi: 10.1302/0301-620X.88B12.18151. — View Citation
Matta JM, Siebenrock KA. Does indomethacin reduce heterotopic bone formation after operations for acetabular fractures? A prospective randomised study. J Bone Joint Surg Br. 1997 Nov;79(6):959-63. doi: 10.1302/0301-620x.79b6.6889. — View Citation
Moore KD, Goss K, Anglen JO. Indomethacin versus radiation therapy for prophylaxis against heterotopic ossification in acetabular fractures: a randomised, prospective study. J Bone Joint Surg Br. 1998 Mar;80(2):259-63. doi: 10.1302/0301-620x.80b2.8157. — View Citation
Sagi HC, Jordan CJ, Barei DP, Serrano-Riera R, Steverson B. Indomethacin prophylaxis for heterotopic ossification after acetabular fracture surgery increases the risk for nonunion of the posterior wall. J Orthop Trauma. 2014 Jul;28(7):377-83. doi: 10.1097/BOT.0000000000000049. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Consent rate | Percentage of participants consented to participate in the study out of all eligible participants approached for consent. | Within 24 hours of surgery | |
Secondary | Comparison of HO formation by HO prophylaxis type (XRT vs no treatment) | Compare post-operative HO formation, defined as a Brooker class I through IV, between patients that received XRT versus no prophylaxis | 12 weeks after surgery | |
Secondary | Comparison of severe HO formation by HO prophylaxis type (XRT vs no treatment) | Compare post-operative severe HO formation, defined as a Brooker class III or IV, between patients that received XRT versus no prophylaxis | 12 weeks after surgery |
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