Sacral FractureNCT04044300
Operative vs Non-Operative Treatment of Sacral Fractures
A study testing Single screw fixation and Conservative in people with Sacral Fracture, run by More Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sacral Fracture
- What is being tested?
- Single screw fixation and Conservative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The CORE Institute
Phoenix, Arizona, 85023
Clifford B Jones, MD, 623-241-8724, clifford.jones@thecoreinstitute.com
Debra L Sietsema, PhD, 623.455.7109, debra.sietsema@thecoreinstitute.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Sacral Fracture
- Being tested
- Single screw fixation, Conservative
- Keywords
- sacral fracture, function, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single screw fixationProcedure or surgery
A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.
ConservativeOther
Continued pain management and physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Operative | Experimental | A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level. Receives: Procedure: Single screw fixation |
| Non-operative | Experimental | Continued pain management and physical therapy Receives: Procedure: Single screw fixation; Other: Conservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) Test
TUG Test
Measured: 2 weeks
Sacral Region Pain
Visual Analog Pain Scale, minimum score 0, maximum score 10, from no pain to worst possible pain
Measured: 2 weeks
Secondary outcomes (6)
Discharge Disposition Location
Location that subject was discharged to at hospital discharge: Home, Rehabilitation, Skilled Nursing Facility
Measured: Up to 21 days
Facility Length of Stay
Number of days in a rehabilitation or skilled nursing facility after hospital discharge
Measured: Up to 21 days
Ambulatory aid
Use of walker, cane, or wheelchair
Measured: 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
Measured: 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.
Measured: 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
Measured: Change from baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study startAug 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Sacral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 to one of two treatment arms
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- More Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Sponsor
- Investigators
- Clifford B Jones, MD, Principal investigator, The CORE Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044300
- Sponsor's protocol ID
- 3209
- Status last verified
- Aug 2019
- First submitted
- 30 Apr 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Newhouse KE, el-Khoury GY, Buckwalter JA. Occult sacral fractures in osteopenic patients. J Bone Joint Surg Am. 1992 Dec;74(10):1472-7.
PubMed 1364816Wild 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.
PubMed 11995886Grasland 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.
PubMed 8629880Galbraith 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.
PubMed 20675092Dasgupta 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.
PubMed 9714359Isdale 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.
PubMed 10334691Lin JT, Lane JM. Sacral stress fractures. J Womens Health (Larchmt). 2003 Nov;12(9):879-88. doi: 10.1089/154099903770948104.
PubMed 14670167Lourie H. Spontaneous osteoporotic fracture of the sacrum. An unrecognized syndrome of the elderly. JAMA. 1982 Aug 13;248(6):715-7.
PubMed 7097924Mears 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.
PubMed 21718260Tsiridis 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.
PubMed 16855863Rommens 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.
PubMed 23871193Sanders 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.
PubMed 27551916Walker 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.
PubMed 29916895Chan 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.
PubMed 23303884Podsiadlo 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.
PubMed 1991946
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial Comparing Percutaneous Screw Fixation to Non-Operative Management for the Treatment of Sacral Fragility Fractures
- ClinicalTrials.gov ID
- NCT04044300
- Acronym / sponsor ID
- 3209
- Conditions
- Sacral Fracture
- Keywords
- sacral fracture, function, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- More FoundationUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Study start
- Aug 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 to one of two treatment arms
| Arm | Type | Receives |
|---|---|---|
| Operative | Experimental | Procedure: Single screw fixationA single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level. |
| Non-operative | Experimental | Procedure: Single screw fixation, Other: ConservativeContinued pain management and physical therapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single screw fixationA single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level based upon fracture location. | Procedure or surgery | Non-operative, Operative |
| ConservativeContinued pain management and physical therapy. | Other | Non-operative |
Primary outcome
Timed Up and Go (TUG) Test
Time frame: 2 weeks
TUG Test
Sacral Region Pain
Time frame: 2 weeks
Visual Analog Pain Scale, minimum score 0, maximum score 10, from no pain to worst possible pain
6 secondary outcomes
Discharge Disposition Location
Time frame: Up to 21 days
Facility Length of Stay
Time frame: Up to 21 days
Ambulatory aid
Time frame: 2 weeks
Complications
Time frame: Up to 1 year
Patient Reported Health Outcome
Time frame: Change from baseline to 1 year
Patient Reported Outcome
Time frame: Change from baseline to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Background: PubMed 1364816Newhouse KE, el-Khoury GY, Buckwalter JA. Occult sacral fractures in osteopenic patients. J Bone Joint Surg Am. 1992 Dec;74(10):1472-7.
- Background: PubMed 11995886Wild 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.
- Background: PubMed 8629880Grasland 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.
- Background: PubMed 20675092Galbraith 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.
- Background: PubMed 9714359Dasgupta 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.
- Background: PubMed 10334691Isdale 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.
- Background: PubMed 14670167Lin JT, Lane JM. Sacral stress fractures. J Womens Health (Larchmt). 2003 Nov;12(9):879-88. doi: 10.1089/154099903770948104.
- Background: PubMed 7097924Lourie H. Spontaneous osteoporotic fracture of the sacrum. An unrecognized syndrome of the elderly. JAMA. 1982 Aug 13;248(6):715-7.
- Background: PubMed 21718260Mears 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.
- Background: PubMed 16855863Tsiridis 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.
- Background: PubMed 23871193Rommens 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.
- Background: PubMed 27551916Sanders 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifford B Jones, MD principal investigator
The CORE Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single screw fixation and Conservative in people with Sacral Fracture, run by More Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clifford B Jones, MD (623.241.8724, clifford.jones@thecoreinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) Test (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04044300, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.