Heterotopic Ossification Prophylaxis

NCT04867278 | Completed Results

• 1 other identifier: HP-00093659
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Acetabular Fracture; Heterotopic Ossification

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Severe HO Formation

  Severe HO formation classified as Brooker class III-IV.

  3 months post-op

Secondary Outcomes (1)

• Number of Participants With Any HO Formation

  3 months post-op

Study Arms (2)

External Beam Radiation (XRT) with Debridement

EXPERIMENTAL

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.

Procedure: External Beam Radiation (XRT); Procedure: Debridement

Debridement Alone (Control)

ACTIVE COMPARATOR

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

Procedure: Debridement

Interventions

External Beam Radiation (XRT) PROCEDURE

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.

External Beam Radiation (XRT) with Debridement

Debridement PROCEDURE

Gluteus minimus debridement in the OR

Debridement Alone (Control); External Beam Radiation (XRT) with Debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged 18+ with an acute acetabular fracture
• Indicated for surgical fixation via a posterior or combined anterior and posterior approach

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (5)

• 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.

  PMID: 24625922 BACKGROUND

• 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.

  PMID: 9393912 BACKGROUND

• 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.

  PMID: 17159174 BACKGROUND

• 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.

  PMID: 9546456 BACKGROUND

• 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.

  PMID: 11741055 BACKGROUND

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

Debridement

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Limitations and Caveats

A limitation of the current study is the fourteen-patient crossover from the XRT treatment arm to no XRT. These 14 patients were randomized to the XRT group, but did not receive XRT at all, thus crossing over to the no XRT group. Additionally, although the sample size was adequately powered, there were a relatively few number of study events. Lastly, although the study is multicenter, it is only 2 centers.

Results Point of Contact

• Title: Dr. Adam Boissonneault
• Organization: Emory University

adam.boissonneault@emory.edu

(404) 616-1000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the UM SOM's Division of Orthopaedic Traumatology and Chief of Orthopaedic Traumatology and CHief of Orthopaedics for the University of Maryland Medical Center's (UMMS) R Adams Cowley Shock Trauma Center

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 30, 2021
• Study Start: May 9, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)