NCT02625766|CompletedResultsDMC
Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial
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Sponsor study identifier
interventional
95
1 country
2
Study Start
April 20, 2015
Actual (reported)Primary Completion
December 10, 2018
Actual (reported)Study Completion
December 31, 2020
Actual (reported)Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures encountered. There is a substantial amount of controversy surrounding the treatment of these injuries and there is evidence that both operative and non-operative treatment can be successful.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2015
Actual (reported)November 19, 2015
Actual (reported)December 9, 2015
Actual (reported)December 10, 2018
Actual (reported)December 31, 2020
Actual (reported)April 8, 2022
Actual (reported)Posttreatment Pain
The primary outcome was patient-reported pain severity, as measured by the mean of the 4 pain severity items of the Brief Pain Inventory (BPI): worst pain in the last 24 hours, least pain in the last 24 hours, pain on average, and pain right now. The BPI uses a 0-10 level visual analog scale (VAS) with a 24-hour recall period, where 0 anchors "no pain" and 10 anchors "pain as bad as you can imagine." The minimum clinically important difference (MCID) is not definitively established for the BPI in a trauma population; however, the MCID for other 10-point VAS pain scales has been reported between 1.0-2.5 points.
up to 12 weeks post injury
Posttreatment Function
up to 12 weeks post injury
Length of Hospitalization
through patient discharge, up to 12 weeks post injury
Time to First Mobilization Post Injury
through patient discharge, up to 12 weeks post injury
Patients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms.
Patients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Indiana University Health
Indianapolis, Indiana, 46202, United States
University of Maryland, Shock Trauma Center
Baltimore, Maryland, 21201, United States
Young JW, Burgess AR, Brumback RJ, Poka A. Lateral compression fractures of the pelvis: the importance of plain radiographs in the diagnosis and surgical management. Skeletal Radiol. 1986;15(2):103-9. doi: 10.1007/BF00350202.
Manson T, O'Toole RV, Whitney A, Duggan B, Sciadini M, Nascone J. Young-Burgess classification of pelvic ring fractures: does it predict mortality, transfusion requirements, and non-orthopaedic injuries? J Orthop Trauma. 2010 Oct;24(10):603-9. doi: 10.1097/BOT.0b013e3181d3cb6b.
The limitations of the trial are primarily related to its sample size and challenges with recruitment into a randomized controlled trial. The decision to enroll patients who refused randomization, but selected their treatment without surgeon's recommendation, was a study design decision carefully made to balance potential risks of bias with the benefits of increased study power from a larger sample size. Additionally, we acknowledge that we were unable to obtain preoperative pain scores.
Robert O'Toole, MD
University of Maryland
95 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2015
First Posted
December 9, 2015
Study Start
April 20, 2015
Actual (reported)Contact the study team to confirm eligibility.
Lindahl J, Hirvensalo E. Outcome of operatively treated type-C injuries of the pelvic ring. Acta Orthop. 2005 Oct;76(5):667-78. doi: 10.1080/17453670510041754.
Routt ML Jr, Kregor PJ, Simonian PT, Mayo KA. Early results of percutaneous iliosacral screws placed with the patient in the supine position. J Orthop Trauma. 1995 Jun;9(3):207-14. doi: 10.1097/00005131-199506000-00005.
Bruce B, Reilly M, Sims S. OTA highlight paper predicting future displacement of nonoperatively managed lateral compression sacral fractures: can it be done? J Orthop Trauma. 2011 Sep;25(9):523-7. doi: 10.1097/BOT.0b013e3181f8be33.
Gaski GE, Manson TT, Castillo RC, Slobogean GP, O'Toole RV. Nonoperative treatment of intermediate severity lateral compression type 1 pelvic ring injuries with minimally displaced complete sacral fracture. J Orthop Trauma. 2014 Dec;28(12):674-80. doi: 10.1097/BOT.0000000000000130.
Kanakaris NK, Angoules AG, Nikolaou VS, Kontakis G, Giannoudis PV. Treatment and outcomes of pelvic malunions and nonunions: a systematic review. Clin Orthop Relat Res. 2009 Aug;467(8):2112-24. doi: 10.1007/s11999-009-0712-2. Epub 2009 Jan 30.
Barei DP, Shafer BL, Beingessner DM, Gardner MJ, Nork SE, Routt ML. The impact of open reduction internal fixation on acute pain management in unstable pelvic ring injuries. J Trauma. 2010 Apr;68(4):949-53. doi: 10.1097/TA.0b013e3181af69be.
Tosounidis T, Kanakaris N, Nikolaou V, Tan B, Giannoudis PV. Assessment of Lateral Compression type 1 pelvic ring injuries by intraoperative manipulation: which fracture pattern is unstable? Int Orthop. 2012 Dec;36(12):2553-8. doi: 10.1007/s00264-012-1685-4. Epub 2012 Oct 25.
Sagi HC, Coniglione FM, Stanford JH. Examination under anesthetic for occult pelvic ring instability. J Orthop Trauma. 2011 Sep;25(9):529-36. doi: 10.1097/BOT.0b013e31822b02ae.
McKibben NS, O'Hara NN, Slobogean GP, Gaski GE, Nascone JW, Sciadini MF, Natoli RM, McKinley T, Virkus WW, Sorkin AT, Howe A, O'Toole RV, Levy JF. Work Productivity Loss After Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2024 Jan 1;38(1):42-48. doi: 10.1097/BOT.0000000000002681.
Slobogean GP, Gaski GE, Nascone J, Sciadini MF, Natoli RM, Manson TT, Lebrun C, McKinley T, Virkus WW, Sorkin AT, Brown K, Howe A, Rudnicki J, Enobun B, O'Hara NN, Gill J, O'Toole RV. A Prospective Clinical Trial Comparing Surgical Fixation Versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2021 Nov 1;35(11):592-598. doi: 10.1097/BOT.0000000000002088.
Primary Completion
December 10, 2018
Actual (reported)Study Completion
December 31, 2020
Actual (reported)Last Updated
May 9, 2022
Results First Posted
April 8, 2022
Record last verified: 2022-04
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