Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-05-05
2026-09-30
Brief Summary
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Detailed Description
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1. Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture
2. Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Operative
Percutaneous screw fixation
Percutaneous screw fixation
Surgical intervention in the form of percutaneous screw fixation
Non-operative
Pain management and physical therapy advanced with weight bearing as tolerated.
Pain management
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Physical therapy
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Interventions
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Percutaneous screw fixation
Surgical intervention in the form of percutaneous screw fixation
Pain management
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Physical therapy
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Eligibility Criteria
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Inclusion Criteria
* Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI
* Low energy mechanism of injury or an insufficiency fracture without a precipitating event
* Acute injury within four weeks of presentation
* Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed "Up \& Go" (TUG) assessment, or inability to complete the TUG assessment.
Exclusion Criteria
* Vertically or rotationally unstable pelvic ring injuries
* Pathologic fracture secondary to tumor
* Non-ambulatory prior to injury
* Acute neurologic deficit
* High-energy mechanism of injury
* Concomitant injuries affecting ambulation
* Presence of another injury or medical condition that prevents ambulation
* Presence of implant or sacral morphology that prevents percutaneous sacral fixation
* Enrollment in another research study the precludes co-enrollment
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)
* Incarcerated or pending incarceration
60 Years
100 Years
ALL
No
Sponsors
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Orthopaedic Trauma Association
OTHER
Allina Health System
OTHER
HealthPartners Institute
OTHER
Responsible Party
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Principal Investigators
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Mai P. Nguyen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota and HealthPartners
Locations
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Allina, Mercy Hospital
Coon Rapids, Minnesota, United States
Park Nicollet, Methodist Hospital
Saint Louis Park, Minnesota, United States
HealthPartners, Regions Hospital
Saint Paul, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Soles GL, Ferguson TA. Fragility fractures of the pelvis. Curr Rev Musculoskelet Med. 2012 Sep;5(3):222-8. doi: 10.1007/s12178-012-9128-9.
Wright NC, Looker AC, Saag KG, Curtis JR, Delzell ES, Randall S, Dawson-Hughes B. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res. 2014 Nov;29(11):2520-6. doi: 10.1002/jbmr.2269.
Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75. doi: 10.1359/jbmr.061113.
Clement ND, Court-Brown CM. Elderly pelvic fractures: the incidence is increasing and patient demographics can be used to predict the outcome. Eur J Orthop Surg Traumatol. 2014 Dec;24(8):1431-7. doi: 10.1007/s00590-014-1439-7. Epub 2014 Mar 25.
Fisher ND, Solasz SJ, Tensae A, Konda SR, Egol KA. Low-energy lateral compression type 1 (LC1) pelvic ring fractures in the middle-aged and elderly affect hospital quality measures and functional outcomes. Eur J Orthop Surg Traumatol. 2022 Oct;32(7):1379-1384. doi: 10.1007/s00590-021-03125-7. Epub 2021 Sep 20.
Mullis BH, Agel J, Jones C, Lowe J, Vallier H, Teague D, Kempton L, Schmidt A, Friess D, Morshed S, Miller AN, Leighton R, Tornetta P 3rd. Unilateral Sacral Fractures Demonstrate Slow Recovery of Patient-Reported Outcomes Irrespective of Treatment. J Orthop Trauma. 2022 Apr 1;36(4):179-183. doi: 10.1097/BOT.0000000000002260.
Beckmann JT, Presson AP, Curtis SH, Haller JM, Stuart AR, Higgins TF, Kubiak EN. Operative agreement on lateral compression-1 pelvis fractures. a survey of 111 OTA members. J Orthop Trauma. 2014 Dec;28(12):681-5. doi: 10.1097/BOT.0000000000000133.
Parry JA, Funk A, Heare A, Stacey S, Mauffrey C, Starr A, Crist B, Krettek C, Jones CB, Kleweno CP, Firoozabadi R, Sagi HC, Archdeacon M, Eastman J, Langford J, Oransky M, Martin M, Cole P, Giannoudis P, Byun SE, Morgan SJ, Smith W, Giordano V, Trikha V. An international survey of pelvic trauma surgeons on the management of pelvic ring injuries. Injury. 2021 Oct;52(10):2685-2692. doi: 10.1016/j.injury.2020.07.027. Epub 2020 Jul 11.
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.
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.
Tornetta P 3rd, Lowe JA, Agel J, Mullis BH, Jones CB, Teague D, Kempton L, Brown K, Friess D, Miller AN, Spitler CA, Kubiak E, Gary JL, Leighton R, Morshed S, Vallier HA. Does Operative Intervention Provide Early Pain Relief for Patients With Unilateral Sacral Fractures and Minimal or No Displacement? J Orthop Trauma. 2019 Dec;33(12):614-618. doi: 10.1097/BOT.0000000000001578.
Walker JB, Mitchell SM, Karr SD, Lowe JA, Jones CB. Percutaneous Transiliac-Transsacral Screw Fixation of Sacral Fragility Fractures Improves Pain, Ambulation, and Rate of Disposition to Home. J Orthop Trauma. 2018 Sep;32(9):452-456. doi: 10.1097/BOT.0000000000001243.
Hopf JC, Krieglstein CF, Muller LP, Koslowsky TC. Percutaneous iliosacral screw fixation after osteoporotic posterior ring fractures of the pelvis reduces pain significantly in elderly patients. Injury. 2015 Aug;46(8):1631-6. doi: 10.1016/j.injury.2015.04.036. Epub 2015 May 14.
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.
Related Links
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American Academy of Orthopaedic Surgeon clinical practice guidelines
Other Identifiers
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A22-184
Identifier Type: -
Identifier Source: org_study_id
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