Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867278
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-08-16
First Post:
2021-04-21
Brief Title:
Heterotopic Ossification Prophylaxis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
External Beam Radiotherapy as Prophylaxis for Heterotopic Ossification After Surgical Fixation of Acetabular Fractures a Prospective Randomized Feasibility Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Heterotopic ossification HO is a common complication after surgical fixation of acetabular fractures with incidence rates reported as high as 90 HO can be a debilitating complication and surgical excision for more severe cases carries a high complication rate Numerous strategies have been employed to prevent HO formation but results are mixed and the optimal treatment strategy remains controversial
The most common modalities used to prevent HO formation are oral administration of indomethacin or single-dose external beam irradiation therapy XRT Despite the common use of indomethacin and observational data to support its use more recent randomized controlled trials RCTs have failed to demonstrate any significant reduction in the incidence of severe HO when patients were administered 6 weeks of indomethacin versus placebo Similarly XRT has been shown to be effective against HO formation in smaller observational studies but there are no adequately powered RCTs to support its use compared to placebo
Given the high incidence impact on outcomes and controversy regarding treatment there remains a need for continued research to determine optimal treatment strategies for HO prophylaxis While XRT remains standard of care for prophylaxis at many centers including our own there are no RCTs to support its use Given the associated cost and resources and potential risk even if minor our study will help determine the feasibility of a larger RCT to help determine if the use of XRT is justified
For this feasibility study eligible patients will be randomized to XRT versus control Both arms 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 The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT We will have 30 patients randomized to each group We will look at consent rate power and HO formation on 3 month post-op radiographs
The most common modalities used to prevent HO formation are oral administration of indomethacin or single-dose external beam irradiation therapy XRT Despite the common use of indomethacin and observational data to support its use more recent randomized controlled trials RCTs have failed to demonstrate any significant reduction in the incidence of severe HO when patients were administered 6 weeks of indomethacin versus placebo Similarly XRT has been shown to be effective against HO formation in smaller observational studies but there are no adequately powered RCTs to support its use compared to placebo
Given the high incidence impact on outcomes and controversy regarding treatment there remains a need for continued research to determine optimal treatment strategies for HO prophylaxis While XRT remains standard of care for prophylaxis at many centers including our own there are no RCTs to support its use Given the associated cost and resources and potential risk even if minor our study will help determine the feasibility of a larger RCT to help determine if the use of XRT is justified
For this feasibility study eligible patients will be randomized to XRT versus control Both arms 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 The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT We will have 30 patients randomized to each group We will look at consent rate power and HO formation on 3 month post-op radiographs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None