Operative vs Non-Operative Treatment of Sacral Fractures
NCT ID: NCT04044300
Last Updated: 2019-08-05
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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UNKNOWN
NA
104 participants
INTERVENTIONAL
2019-08-31
2021-12-31
Brief Summary
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Detailed Description
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Subjects will undergo a 48 hour period of physical therapy and pain management following identification of the sacral fracture.. If the subject has substantial pain or disability, the subject is eligible for enrollment in the RCT and randomization of 1:1 to one of two groups.
Group 1: Operative treatment: A single trans iliac trans sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.
Group 2: Conservative (non-operative) treatment: Continued pain management and physical therapy advanced with weight bearing as tolerated.
The purpose of this study is to compare percutaneous trans-iliac trans-sacral screw fixation to non-operative management for the treatment of symptomatic, sacral fragility fractures in elderly patients.
Primary Objective: To compare the functional outcome and pain in elderly patients surgically treated compared to those non-operatively treated for sacral fractures.
Secondary Objective: To compare discharge disposition, length of stay in care facility post-discharge, complications, and need for ambulatory aid in elderly patients surgically treated compared to those non-operatively treated for sacral fractures.
Hypothesis: Subjects in the operative group will have improvement in functional outcome and pain at 2 weeks, higher likelihood of discharge to independent living, shorter stays in care facilities post-discharge, less complications, and less need for ambulatory aids.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Operative
A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level.
Single screw fixation
A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.
Non-operative
Continued pain management and physical therapy
Single screw fixation
A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.
Conservative
Continued pain management and physical therapy.
Interventions
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Single screw fixation
A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.
Conservative
Continued pain management and physical therapy.
Eligibility Criteria
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Inclusion Criteria
2. Pelvic ring fractures classified as LC1 or sacral U, confirmed with plain radiographs, CT and/or MRI
3. Fracture is the result of a low energy mechanism of injury or an insufficiency fracture without a precipitating event
4. Onset of symptoms within four weeks of presentation to hospital
5. Significant pain or disability determined by:
1. Reported pain score ≥ 7 using the Visual Analogue Score (VAS) after a Timed "Up \& Go" (TUG) test, or
2. Inability to complete the TUG test
3. Inability to get out of bed secondary to pain for 2 consecutive days
Exclusion Criteria
2. Pathologic fracture secondary to tumor
3. Non-ambulatory prior to injury
4. Acute neurologic deficit
5. High-energy mechanism of injury
6. Concomitant lower extremity fractures affecting ambulation
7. Presence of another injury or medical condition that prevents ambulation
8. Presence of hardware or sacral morphology that prevents percutaneous sacral fixation
9. Enrollment in another research study that precludes co-enrollment
10. Inability to speak English
11. Dementia with inability to answer questions and participate in study
12. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)
13. Incarcerated or pending incarceration
60 Years
ALL
No
Sponsors
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Orthopaedic Trauma Association
OTHER
More Foundation
OTHER
Responsible Party
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Principal Investigators
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Clifford B Jones, MD
Role: PRINCIPAL_INVESTIGATOR
The CORE Institute
Locations
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The CORE Institute
Phoenix, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Newhouse KE, el-Khoury GY, Buckwalter JA. Occult sacral fractures in osteopenic patients. J Bone Joint Surg Am. 1992 Dec;74(10):1472-7.
Wild A, Jaeger M, Haak H, Mehdian SH. Sacral insufficiency fracture, an unsuspected cause of low-back pain in elderly women. Arch Orthop Trauma Surg. 2002 Feb;122(1):58-60. doi: 10.1007/s004020100333.
Grasland A, Pouchot J, Mathieu A, Paycha F, Vinceneux P. Sacral insufficiency fractures: an easily overlooked cause of back pain in elderly women. Arch Intern Med. 1996 Mar 25;156(6):668-74. doi: 10.1001/archinte.156.6.668.
Galbraith JG, Butler JS, Blake SP, Kelleher G. Sacral insufficiency fractures: an easily overlooked cause of back pain in the ED. Am J Emerg Med. 2011 Mar;29(3):359.e5-6. doi: 10.1016/j.ajem.2010.04.015. Epub 2010 Aug 2.
Dasgupta B, Shah N, Brown H, Gordon TE, Tanqueray AB, Mellor JA. Sacral insufficiency fractures: an unsuspected cause of low back pain. Br J Rheumatol. 1998 Jul;37(7):789-93. doi: 10.1093/rheumatology/37.7.789.
Isdale AH. Sacral insufficiency fractures: an unsuspected cause of low back pain. Rheumatology (Oxford). 1999 Jan;38(1):90. doi: 10.1093/rheumatology/38.1.90a. No abstract available.
Lin JT, Lane JM. Sacral stress fractures. J Womens Health (Larchmt). 2003 Nov;12(9):879-88. doi: 10.1089/154099903770948104.
Lourie H. Spontaneous osteoporotic fracture of the sacrum. An unrecognized syndrome of the elderly. JAMA. 1982 Aug 13;248(6):715-7.
Mears SC, Berry DJ. Outcomes of displaced and nondisplaced pelvic and sacral fractures in elderly adults. J Am Geriatr Soc. 2011 Jul;59(7):1309-12. doi: 10.1111/j.1532-5415.2011.03455.x. Epub 2011 Jun 30.
Tsiridis E, Upadhyay N, Giannoudis PV. Sacral insufficiency fractures: current concepts of management. Osteoporos Int. 2006 Dec;17(12):1716-25. doi: 10.1007/s00198-006-0175-1. Epub 2006 Jul 20.
Rommens PM, Hofmann A. Comprehensive classification of fragility fractures of the pelvic ring: Recommendations for surgical treatment. Injury. 2013 Dec;44(12):1733-44. doi: 10.1016/j.injury.2013.06.023. Epub 2013 Jul 18.
Sanders D, Fox J, Starr A, Sathy A, Chao J. Transsacral-Transiliac Screw Stabilization: Effective for Recalcitrant Pain Due to Sacral Insufficiency Fracture. J Orthop Trauma. 2016 Sep;30(9):469-73. doi: 10.1097/BOT.0000000000000596.
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.
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
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.
Sembler Soles GL, Lien J, Tornetta P 3rd. Nonoperative immediate weightbearing of minimally displaced lateral compression sacral fractures does not result in displacement. J Orthop Trauma. 2012 Oct;26(10):563-7. doi: 10.1097/BOT.0b013e318251217b.
Eckardt H, Egger A, Hasler RM, Zech CJ, Vach W, Suhm N, Morgenstern M, Saxer F. Good functional outcome in patients suffering fragility fractures of the pelvis treated with percutaneous screw stabilisation: Assessment of complications and factors influencing failure. Injury. 2017 Dec;48(12):2717-2723. doi: 10.1016/j.injury.2017.11.002. Epub 2017 Nov 4.
Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. doi: 10.1186/1471-2474-6-3.
Gautschi OP, Stienen MN, Corniola MV, Joswig H, Schaller K, Hildebrandt G, Smoll NR. Assessment of the Minimum Clinically Important Difference in the Timed Up and Go Test After Surgery for Lumbar Degenerative Disc Disease. Neurosurgery. 2017 Mar 1;80(3):380-385. doi: 10.1227/NEU.0000000000001320.
Other Identifiers
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3209
Identifier Type: -
Identifier Source: org_study_id
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