Operative vs Non-Operative Treatment of Sacral Fractures

NCT04044300 | Unknown DMC

• 1 other identifier: 3209
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sacral Fracture

Keywords

sacral fracture, function, pain

Outcome Measures

Primary Outcomes (2)

• Timed Up and Go (TUG) Test

  TUG Test

  2 weeks

• Sacral Region Pain

  Visual Analog Pain Scale, minimum score 0, maximum score 10, from no pain to worst possible pain

  2 weeks

Secondary Outcomes (6)

• Discharge Disposition Location

  Up to 21 days

• Facility Length of Stay

  Up to 21 days

• Ambulatory aid

  2 weeks

• Complications

  Up to 1 year

• Patient Reported Health Outcome

  Change from baseline to 1 year

Other Outcomes (3)

• Hospital length of stay

  Up to 21 days

• Narcotic use

  2 weeks

• Healing

  Change in healing from baseline to 1 year

Study Arms (2)

Operative

EXPERIMENTAL

A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level.

Procedure: Single screw fixation

Non-operative

EXPERIMENTAL

Continued pain management and physical therapy

Procedure: Single screw fixation; Other: Conservative

Interventions

Single screw fixation PROCEDURE

A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.

Non-operative; Operative

Conservative OTHER

Continued pain management and physical therapy.

Non-operative

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 60 years of age
• Pelvic ring fractures classified as LC1 or sacral U, confirmed with plain radiographs, CT and/or MRI
• Fracture is the result of a low energy mechanism of injury or an insufficiency fracture without a precipitating event
• Onset of symptoms within four weeks of presentation to hospital
• Significant pain or disability determined by:
• Reported pain score ≥ 7 using the Visual Analogue Score (VAS) after a Timed "Up \& Go" (TUG) test, or
• Inability to complete the TUG test
• Inability to get out of bed secondary to pain for 2 consecutive days

You may not qualify if:

• 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 lower extremity fractures affecting ambulation
• Presence of another injury or medical condition that prevents ambulation
• Presence of hardware or sacral morphology that prevents percutaneous sacral fixation
• Enrollment in another research study that precludes co-enrollment
• Inability to speak English
• Dementia with inability to answer questions and participate in study
• 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.)
• Incarcerated or pending incarceration

Sponsors & Collaborators

• More Foundation: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (1)

The CORE Institute

Phoenix, Arizona, 85023, United States

RECRUITING

Related Publications (19)

• Newhouse KE, el-Khoury GY, Buckwalter JA. Occult sacral fractures in osteopenic patients. J Bone Joint Surg Am. 1992 Dec;74(10):1472-7.

  PMID: 1364816 BACKGROUND

• 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.

  PMID: 11995886 BACKGROUND

• 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.

  PMID: 8629880 BACKGROUND

• 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.

  PMID: 20675092 BACKGROUND

• 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.

  PMID: 9714359 BACKGROUND

• 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.

  PMID: 10334691 BACKGROUND

• Lin JT, Lane JM. Sacral stress fractures. J Womens Health (Larchmt). 2003 Nov;12(9):879-88. doi: 10.1089/154099903770948104.

  PMID: 14670167 BACKGROUND

• Lourie H. Spontaneous osteoporotic fracture of the sacrum. An unrecognized syndrome of the elderly. JAMA. 1982 Aug 13;248(6):715-7.

  PMID: 7097924 BACKGROUND

• 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.

  PMID: 21718260 BACKGROUND

• 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.

  PMID: 16855863 BACKGROUND

• 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.

  PMID: 23871193 BACKGROUND

• 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.

  PMID: 27551916 BACKGROUND

• 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.

  PMID: 29916895 BACKGROUND

• 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.

  PMID: 23303884 BACKGROUND

• 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.

  PMID: 1991946 BACKGROUND

• 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.

  PMID: 22495523 BACKGROUND

• 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.

  PMID: 29122281 BACKGROUND

• 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.

  PMID: 15679884 BACKGROUND

• 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.

  PMID: 27352275 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Clifford B Jones, MD

  The CORE Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clifford B Jones, MD

CONTACT

623.241.8724; clifford.jones@thecoreinstitute.com

Debra L Sietsema, PhD

CONTACT

623.455.7109; debra.sietsema@thecoreinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 to one of two treatment arms

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: August 5, 2019
• Study Start: August 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)