TY - JOUR
T1 - The impact of heterotopic ossification prophylaxis after surgical fixation of acetabular fractures
T2 - national treatment patterns and related outcomes
AU - The PREP-IT Investigators
AU - Executive Committee
AU - Steering Committee
AU - Adjudication Committee
AU - Data and Safety Monitoring Committee
AU - Research Methodology Core
AU - Patient Centred Outcomes Core
AU - Orthopaedic Surgery Core
AU - Operating Room Core
AU - Infectious Disease Core
AU - Military Core
AU - McMaster University Methods Center (Hamilton, ON)
AU - University of Maryland School of Medicine Administrative Center (Baltimore, MD)
AU - University of Maryland School of Pharmacy, The PATIENTS Program (Baltimore, MD)
AU - PREP-IT Clinical Sites
AU - Lead Clinical Site (Aqueous-PREP and PREPARE)
AU - University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD
AU - Aqueous-PREP and PREPARE
AU - Hamilton Health Sciences – General Site, Hamilton, ON
AU - Prisma Health - Upstate, Greenville, SC
AU - IU Health Methodist Hospital, Indianapolis, IN
AU - San Antonio Military Medical Center, San Antonio, TX
AU - University of California, San Francisco, San Francisco, CA
AU - Aqueous-PREP
AU - Vanderbilt Medical Center, Nashville, TN
AU - University of Florida, Gainesville, FL
AU - McGovern Medical School at UTHealth Houston, Houston, TX
AU - Wright State University, Dayton, OH
AU - Banner University Medical Center – Tucson, Tucson, AZ
AU - The CORE Institute, Phoenix, AZ
AU - Vall d'Hebron University Hospital, Barcelona, Spain
AU - Hospital Universitari Parc Tauli, Barcelona, Spain
AU - PREPARE
AU - FRASER HEALTH AUTHORITY/Royal Columbian Hospital, New Westminster, BC
AU - Inova Fairfax Medical Campus, Falls Church, VA
AU - Wake Forest Baptist Health, Winston-Salem, NC
AU - MetroHealth Medical Center, Cleveland, OH
AU - University of Utah, Salt Lake City, Utah
AU - University of Mississippi Medical Center, Jackson, MS
AU - Sanford Health, Sioux Falls, SD
AU - Dartmouth-Hitchcock Medical Center, Lebanon, NH
AU - Carolinas Medical Center, Atrium Health Musculoskeletal Institute, Charlotte, NC
AU - University of Maryland, Capital Region Health, Largo, MD
AU - University of Wisconsin Madison, Madison, WI
AU - Duke University Hospital, Durham, NC
AU - Brigham Women's Hospital, Boston, MA
AU - University of Pennsylvania, Philadelphia, PA
AU - Massachusetts General Hospital, Boston, MA
AU - Bryan Medical Center, Lincoln, Nebraska
AU - University of Cincinnati, Cincinnati, OH
AU - Cedars-Sinai Medical Center, Los Angeles, CA
AU - University of California, Irvine, Orange, CA
AU - Boissonneault, Adam
AU - O Hara, Nathan
AU - Pogorzelski, David
AU - Marchand, Lucas
AU - Higgins, Thomas
AU - Gitajn, Leah
AU - Gage, Mark J.
AU - Natoli, Roman M.
AU - Sharma, Ishani
AU - Pierrie, Sarah
AU - O'Toole, Robert V.
AU - Sprague, Sheila
AU - Slobogean, Gerard
AU - Slobogean, Gerard P.
AU - Wells, Jeffrey
AU - Bhandari, Mohit
AU - Harris, Anthony D.
AU - Mullins, C. Daniel
AU - Thabane, Lehana
AU - Wood, Amber
AU - Rocca, Gregory J.Della
AU - Hebden, Joan
AU - Jeray, Kyle J.
AU - Marchand, Lucas S.
AU - O'Hara, Lyndsay M.
AU - Zura, Robert
AU - Lee, Christopher
AU - Patterson, Joseph
AU - Gardner, Michael J.
AU - Blasman, Jenna
AU - Davies, Jonah
AU - Liang, Stephen
AU - Taljaard, Monica
AU - Devereaux, P. J.
AU - Guyatt, Gordon H.
AU - Heels-Ansdell, Diane
AU - Marvel, Debra
AU - Wells, Jana Palmer Jeffrey
AU - Friedrich, Jeff
AU - O'Hara, Nathan N.
AU - Grissom, Frances
AU - Gitajn, I. Leah
AU - Morshed, Saam
AU - O'Toole, Robert V.
AU - Petrisor, Bradley A.
AU - Mossuto, Franca
AU - Joshi, Manjari G.
AU - D'Alleyrand, Jean Claude
AU - Fowler, Justin
AU - Rivera, Jessica
N1 - Publisher Copyright:
© 2023
PY - 2023/6
Y1 - 2023/6
N2 - Background: Heterotopic ossification (HO) is a common complication after surgical fixation of acetabular fractures. Numerous strategies have been employed to prevent HO formation, but results are mixed and optimal treatment strategy remains controversial. The purpose of the study was to describe current national heterotopic ossification (HO) prophylaxis patterns among academic trauma centers, determine the association between prophylaxis type and radiographic HO, and identify if heterogeneity in treatment effects exist based on outcome risk strata. Methods: We used data from a subset of participants enrolled in the Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities (PREPARE) trial. We included only patients with closed AO-type 62 acetabular fractures that were surgically treated via a posterior (Kocher-Langenbeck), combined anterior and posterior, or extensile exposure. PREPARE Clinical Trial Registration Number: NCT03523962 Patient population This cohort study was nested within the Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities (PREPARE) trial. The PREPARE trial is a multicenter cluster-randomized crossover trial evaluating the effectiveness of two alcohol-based pre-operative antiseptic skin solutions. All PREPARE trial clinical centers that enrolled at least one patient with a closed AO-type 62 acetabular fracture were invited to participate in the nested study. Results: 277 patients from 20 level 1 and level 2 trauma centers in the U.S. and Canada were included in this study. 32 patients (12%) received indomethacin prophylaxis, 100 patients (36%) received XRT prophylaxis, and 145 patients (52%) received no prophylaxis. Administration of XRT was associated with a 68% reduction in the adjusted odds of overall HO (OR 0.32, 95% CI, 0.14 – 0.69, p = 0.005). The overall severe HO (Brooker classes III or IV) rate was 8% for the entire cohort; XRT reduced the rate of severe HO in high-risk patients only (p=0.03). Conclusion: HO prophylaxis patterns after surgical fixation of acetabular fractures have changed dramatically over the last two decades. Most centers included in this study did not administer HO prophylaxis. XRT was associated with a marked reduction in the rate of overall HO and the rate of severe HO in high-risk patients. Randomized trials are needed to fully elucidate the potential benefit of XRT. PREPARE Clinical Trial Registration Number: NCT03523962.
AB - Background: Heterotopic ossification (HO) is a common complication after surgical fixation of acetabular fractures. Numerous strategies have been employed to prevent HO formation, but results are mixed and optimal treatment strategy remains controversial. The purpose of the study was to describe current national heterotopic ossification (HO) prophylaxis patterns among academic trauma centers, determine the association between prophylaxis type and radiographic HO, and identify if heterogeneity in treatment effects exist based on outcome risk strata. Methods: We used data from a subset of participants enrolled in the Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities (PREPARE) trial. We included only patients with closed AO-type 62 acetabular fractures that were surgically treated via a posterior (Kocher-Langenbeck), combined anterior and posterior, or extensile exposure. PREPARE Clinical Trial Registration Number: NCT03523962 Patient population This cohort study was nested within the Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities (PREPARE) trial. The PREPARE trial is a multicenter cluster-randomized crossover trial evaluating the effectiveness of two alcohol-based pre-operative antiseptic skin solutions. All PREPARE trial clinical centers that enrolled at least one patient with a closed AO-type 62 acetabular fracture were invited to participate in the nested study. Results: 277 patients from 20 level 1 and level 2 trauma centers in the U.S. and Canada were included in this study. 32 patients (12%) received indomethacin prophylaxis, 100 patients (36%) received XRT prophylaxis, and 145 patients (52%) received no prophylaxis. Administration of XRT was associated with a 68% reduction in the adjusted odds of overall HO (OR 0.32, 95% CI, 0.14 – 0.69, p = 0.005). The overall severe HO (Brooker classes III or IV) rate was 8% for the entire cohort; XRT reduced the rate of severe HO in high-risk patients only (p=0.03). Conclusion: HO prophylaxis patterns after surgical fixation of acetabular fractures have changed dramatically over the last two decades. Most centers included in this study did not administer HO prophylaxis. XRT was associated with a marked reduction in the rate of overall HO and the rate of severe HO in high-risk patients. Randomized trials are needed to fully elucidate the potential benefit of XRT. PREPARE Clinical Trial Registration Number: NCT03523962.
KW - Acetabular fractures
KW - Heterotopic ossification
KW - Indomethacin prophylaxis
KW - XRT prophylaxis
UR - http://www.scopus.com/inward/record.url?scp=85151292751&partnerID=8YFLogxK
U2 - 10.1016/j.injury.2023.03.001
DO - 10.1016/j.injury.2023.03.001
M3 - Article
C2 - 37002119
AN - SCOPUS:85151292751
SN - 0020-1383
VL - 54
SP - 1693
EP - 1701
JO - Injury
JF - Injury
IS - 6
ER -