Operative vs Non-Operative Treatment of Sacral Fractures

A Prospective, Randomized Controlled Trial Comparing Percutaneous Screw Fixation to Non-Operative Management for the Treatment of Sacral Fragility Fractures

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.

Study Overview

• Status: Unknown
• Conditions: Sacral Fracture
• Intervention / Treatment: Procedure: Single screw fixation; Other: Conservative

Detailed Description

Sacral fragility fractures cause significant pain and morbidity in the elderly population in which they occur. These low-energy pelvic injuries can cause prolonged immobility, long hospital stays, and requirement for higher levels of care.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Recruiting
      • The CORE Institute
      • Contact: Debra L Sietsema, PhD; Phone Number: 623.455.7109; Email: debra.sietsema@thecoreinstitute.com
      • Contact: Clifford B Jones, MD; Phone Number: 623-241-8724; Email: clifford.jones@thecoreinstitute.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients ≥ 60 years of age
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:

1. Vertically or rotationally unstable pelvic ring injuries
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Operative; A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level.	Procedure: 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.
EXPERIMENTAL: Non-operative; Continued pain management and physical therapy	Procedure: 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.; Other: Conservative; Continued pain management and physical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharge Disposition Location	Location that subject was discharged to at hospital discharge: Home, Rehabilitation, Skilled Nursing Facility	Up to 21 days
Facility Length of Stay	Number of days in a rehabilitation or skilled nursing facility after hospital discharge	Up to 21 days
Ambulatory aid	Use of walker, cane, or wheelchair	2 weeks
Complications	Screw migration, secondary surgery related to primary procedure, neurological deficit related to screw insertion, surgical site infection, wound dehiscence, deep infection, related re-admission, decubitus ulcer, pneumonia, deep vein thrombosis, pulmonary embolism, death	Up to 1 year
Patient Reported Health Outcome	Veterans Rand 12-item Health Survey (VR-12). This is a health related quality of life survey with 2 scores, Physical Component Score (PCS) including general health, physical functioning, physical role accomplishment, bodily pain and Mental Component Score (MCS) including role-emotional, vitality/mental health, social functioning. The results of the VR-12 are reported as 2 scores, MCS and PCS. The score range is 0-100 for each score, where a 0 score indicates the lowest level of health and a score of 100 indicates the highest level of health. The US population average PCS and MCS are both 50 points. The standard deviation is 10 points.	Change from baseline to 1 year
Patient Reported Outcome	Hip dysfunction and Osteoarthritis Outcome Score (HOOS), Total score of 0-100 with higher scores representing better function	Change from baseline to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Number of days hospitalized	Up to 21 days
Narcotic use	Use of narcotic pain medication, total in milligram equivalents	2 weeks
Healing	Standard pelvic radiographs (AP, inlet, outlet, and lateral sacral views) will be performed to evaluate radiographic outcomes such as fracture healing, fixation failure, and fracture displacement.	Change in healing from baseline to 1 year

Collaborators and Investigators

• Sponsor: More Foundation
• Collaborators: Orthopaedic Trauma Association
• Investigators: Principal Investigator: Clifford B Jones, MD, The CORE Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (ACTUAL): August 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: sacral fracture, function, pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 3209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No