Status:
TERMINATED
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
Lead Sponsor:
SI-BONE, Inc.
Conditions:
Fracture;Pelvis
Sacral Fracture
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficien...
Detailed Description
SAFFRON is a prospective, multicenter, randomized, controlled trial of surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint vs. ...
Eligibility Criteria
Inclusion
- ≥ 60 years of age at screening.
- Posterior pelvic pain correlating with fracture location that began EITHER within 14 days of a low-energy traumatic event, OR in the last 60 days in the absence of a traumatic event
- Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral)
- Patient is either bedbound or must use a wheelchair to cover distances more than 50ft
- Prior to fracture, patient was able to ambulate using a cane or unassisted
- Medically stable to undergo either surgical or non-surgical treatment of index fracture.
- Patient is willing and able to provide written informed consent
- Patient is mentally able to comply with study protocol requirements
Exclusion
- Patient requires surgery to address fracture in the pelvic ring (NSM not feasible)
- Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum
- Sacral fracture potentially or definitely related to tumor
- Any permanent implants already in the sacrum (including cement), ilium, or anterior pelvic ring that could interfere with placement of transiliac transsacral or iliosacral screws or iFuse-TORQ implants
- History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium.
- Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture
- Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments
- Prominent neurologic condition that would interfere with study participation including the use of electronic diaries (e.g., dementia) or recovery of mobility (e.g., severe diabetic neuropathy, multiple sclerosis)
- Known allergy to titanium or titanium alloys
- Current local or systemic infection that raises the risk of surgery.
- Known or suspected active drug or alcohol abuse, including opioids.
- Patient lives or plans to move more than 100 miles from the site during the course of the study.
- Current enrollment in another investigational clinical trial related to fractures or osteoporosis
Key Trial Info
Start Date :
September 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05426356
Start Date
September 18 2022
End Date
June 15 2024
Last Update
October 24 2024
Active Locations (7)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
Bryan Health Medical Center
Lincoln, Nebraska, United States, 68501
3
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
4
Orthopedic Associates of Reading
Wyomissing, Pennsylvania, United States, 19610