Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
NCT ID: NCT02625766
Last Updated: 2022-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2015-04-20
2020-12-31
Brief Summary
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Detailed Description
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There is evidence in the literature to support both operative and non-operative treatment of patients with LC1 or LC2 pelvic fractures. There is conflicting evidence that surgical stabilization decreases acute pain and narcotic requirements, although patients are often counseled to that effect. The investigators propose to prospectively randomize patients with lateral compression type pelvic fractures to non-operative versus operative treatment and track which group has less pain, less need for narcotic pain medications, and who mobilizes with physical therapy faster.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Operative
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.
LC fracture surgical fixation
Non-operative
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.
LC fracture non-operative management
Interventions
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LC fracture surgical fixation
LC fracture non-operative management
Eligibility Criteria
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Inclusion Criteria
* The patient is between 18 and 80 years of age, inclusive
* The patient has reached skeletal maturity
* The patient's pelvic fracture is a result of trauma (includes polytraumatized patients)
* The patient/family/guardian is English-speaking
* The patient's surgeon agrees to randomization (the patient is amendable to either operative or non-operative treatment)
* Patient enrollment and, if applicable, patient randomization can occur within 96 hours post injury
Exclusion Criteria
* The patient's pelvic fracture is classified as a Lateral compression type 1 and the associated sacral fracture is incomplete as indicated by failure to violate both the anterior and posterior cortex
* The patient received prior surgical intervention for his/her current pelvic injury
* The patient has sacral morphology that precludes percutaneous fixation
* The patient is non-ambulatory due to an associated spinal cord injury
* The patient was non-ambulatory pre-injury
* The patient is currently pregnant
* The patient is enrolled in another research study that does not allow co-enrollment
* The patient is likely to have severe problems with maintaining follow-up
18 Years
80 Years
ALL
No
Sponsors
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Indiana University Health
OTHER
University of Maryland, Baltimore
OTHER
Responsible Party
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Robert O'Toole
Head of the UM SOM's Division of Orthpaedic Traumatology and Chief of Orthopaedics for the University of Maryland Medical Center's (UMMC) R Adams Cowley Shock Trauma Center
Principal Investigators
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Robert O'Toole, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland
Locations
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Indiana University Health
Indianapolis, Indiana, United States
University of Maryland, Shock Trauma Center
Baltimore, Maryland, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HP-00060038
Identifier Type: -
Identifier Source: org_study_id
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