Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
Stopped: Enrollment difficulties
United States28 participantsStarted 2022-09-18
Plain-language 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 insufficiency fractures
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥ 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 criteria
✕. 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
What they're measuring
1
Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).
Timeframe: 1 year
2
Proportion of subjects with serious adverse event (SAE) probably or definitely related to a complication of sacral fracture and/or associated treatment (both arms) or probably or definitely related to iFuse-TORQ (surgery only).
✕. 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)