Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
Stopped early · Not applicable
Conditions studied: Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture, Insufficiency Fractures, Osteoporosis
In brief
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 insufficiency fractures
Key facts
- Study ID
- NCT05426356
- Run by
- SI-BONE, Inc.
- People needed
- 28
- Starts
- 2022-09-18
- Expected to finish
- 2024-06-15
- Last updated by the study team
- 2024-10-24
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- University of Chicago — Chicago, Illinois, United States
- Bryan Health Medical Center — Lincoln, Nebraska, United States
- Saint Barnabas Medical Center — Livingston, New Jersey, United States
- Orthopedic Associates of Reading — Wyomissing, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- University of Virginia — Charlottesville, Virginia, United States
- Kadlec Clinic Northwest Orthopedic & Sports Medicine — Richland, Washington, United States
Full record on ClinicalTrials.gov
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