Acetabular FractureNCT04867278
Heterotopic Ossification Prophylaxis
A study testing External Beam Radiation (XRT) and Debridement in people with Acetabular Fracture and Heterotopic Ossification, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture, Heterotopic Ossification
- What is being tested?
- External Beam Radiation (XRT) and Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 18+ with an acute acetabular fracture
- Indicated for surgical fixation via a posterior or combined anterior and posterior approach
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Shock Trauma Center
Baltimore, Maryland, 21201
About this study
Official title: External Beam Radiotherapy as Prophylaxis for Heterotopic Ossification After Surgical Fixation of Acetabular Fractures: a Prospective, Randomized Feasibility Study
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.
Read the 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.
- Conditions
- Acetabular Fracture, Heterotopic Ossification
- Being tested
- External Beam Radiation (XRT), Debridement
- Medical subject headings
- Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Beam Radiation (XRT)Procedure or surgery
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.
DebridementProcedure or surgery
Gluteus minimus debridement in the OR
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Severe HO Formation
Severe HO formation classified as Brooker class III-IV.
Measured: 3 months post-op
Secondary outcomes (1)
Number of Participants With Any HO Formation
Any HO formation classified as Brooker class I-IV.
Measured: 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start9 May 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acetabular FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert O'Toole, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867278
- Sponsor's protocol ID
- HP-00093659
- Status last verified
- Nov 2024
- First submitted
- 21 Apr 2021
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24625922Matta 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.
PubMed 9393912Karunakar 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.
PubMed 17159174Moore 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.
PubMed 9546456Burd 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.
PubMed 11741055
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Beam Radiotherapy as Prophylaxis for Heterotopic Ossification After Surgical Fixation of Acetabular Fractures: a Prospective, Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT04867278
- Acronym / sponsor ID
- HP-00093659
- Conditions
- Acetabular Fracture, Heterotopic Ossification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 9 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Beam Radiation (XRT) with Debridement | Experimental | Procedure: External Beam Radiation (XRT), Procedure: DebridementPatients 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. |
| Debridement Alone (Control) | Active comparator | Procedure: DebridementThe control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult aged 18+ with an acute acetabular fracture
- Indicated for surgical fixation via a posterior or combined anterior and posterior approach
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Beam Radiation (XRT)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. | Procedure or surgery | External Beam Radiation (XRT) with Debridement |
| DebridementGluteus minimus debridement in the OR | Procedure or surgery | Debridement Alone (Control), External Beam Radiation (XRT) with Debridement |
Primary outcome
Number of Participants With Severe HO Formation
Time frame: 3 months post-op
Severe HO formation classified as Brooker class III-IV.
1 secondary outcome
Number of Participants With Any HO Formation
Time frame: 3 months post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24625922Sagi 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.
- Background: PubMed 9393912Matta 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.
- Background: PubMed 17159174Karunakar 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.
- Background: PubMed 9546456Moore 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.
- Background: PubMed 11741055Burd 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Beam Radiation (XRT) and Debridement in people with Acetabular Fracture and Heterotopic Ossification, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Severe HO Formation (time frame: 3 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04867278, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.