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Heterotopic Ossification Prophylaxis

Primary Purpose

Acetabular Fracture, Heterotopic Ossification

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
External Beam Radiation (XRT)
Debridement
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acetabular Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Maryland, Shock Trauma Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

External Beam Radiation (XRT) with Debridement

Debridement Alone (Control)

Arm Description

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.

The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT.

Outcomes

Primary Outcome Measures

Consent rate
Percentage of participants consented to participate in the study out of all eligible participants approached for consent.

Secondary Outcome Measures

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
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

Full Information

First Posted
April 21, 2021
Last Updated
August 14, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT04867278
Brief Title
Heterotopic Ossification Prophylaxis
Official Title
External Beam Radiotherapy as Prophylaxis for Heterotopic Ossification After Surgical Fixation of Acetabular Fractures: a Prospective, Randomized Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 9, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acetabular Fracture, Heterotopic Ossification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
External Beam Radiation (XRT) with Debridement
Arm Type
Experimental
Arm Description
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.
Arm Title
Debridement Alone (Control)
Arm Type
Active Comparator
Arm Description
The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT.
Intervention Type
Procedure
Intervention Name(s)
External Beam Radiation (XRT)
Intervention Description
Patients that undergo surgical fixation of an acetabular fracture will receive debridement and a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery.
Intervention Type
Procedure
Intervention Name(s)
Debridement
Intervention Description
Gluteus minimus debridement in the OR
Primary Outcome Measure Information:
Title
Consent rate
Description
Percentage of participants consented to participate in the study out of all eligible participants approached for consent.
Time Frame
Within 24 hours of surgery
Secondary Outcome Measure Information:
Title
Comparison of HO formation by HO prophylaxis type (XRT vs no treatment)
Description
Compare post-operative HO formation, defined as a Brooker class I through IV, between patients that received XRT versus no prophylaxis
Time Frame
12 weeks after surgery
Title
Comparison of severe HO formation by HO prophylaxis type (XRT vs no treatment)
Description
Compare post-operative severe HO formation, defined as a Brooker class III or IV, between patients that received XRT versus no prophylaxis
Time Frame
12 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University of Maryland, Shock Trauma Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24625922
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.
Results Reference
background
PubMed Identifier
9393912
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.
Results Reference
background
PubMed Identifier
17159174
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.
Results Reference
background
PubMed Identifier
9546456
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.
Results Reference
background
PubMed Identifier
11741055
Citation
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.
Results Reference
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Heterotopic Ossification Prophylaxis

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