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
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. nonsurgical management (NSM). The goal of the study is to demonstrate the safety, performance, effectiveness, and cost-effectiveness of use of iFuse-TORQ™ in the treatment of sacral fragility or insufficiency fractures vs. NSM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ
Non-surgical management (NSM) is any treatment deemed appropriate for the subject that does not involve surgery.
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
Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).
The study's primary efficacy endpoint is the time required to achieve an improvement from baseline (study entry) of 2 or more points on the Modified Functional Mobility scale. The scale is administered on a weekly basis following the initiation of treatment until achieving a 2-point improvement or the subject crosses over.
Time frame: 1 year
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).
If randomized to surgery: Proportion of subjects with either: * Serious adverse event deemed probably or definitely related to iFuse-TORQ * Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment If randomized to NSM: Proportion of subjects with: * Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment
Time frame: 1 year
Continuous Summary Physical Performance Score (CSPPS)
Change of CSPPS scores at 6 weeks and 12 months. Continuous Summary Physical Performance Score (CSPPS) is a scoring system based on the Short Physical Performance Battery (SPPB) that is optimized for use in the elderly.
Time frame: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function
Change from baseline in self reported PROMIS physical function score at 6 weeks. This domain is scored between 1 (unable to do) and 5 (can be done without difficulty).
Time frame: 6 weeks
Oswestry Disability Index
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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
Change from baseline in self reported Oswestry Disability Index at 6 weeks. Calculated scores range from 0 (no disability) to 50 (completely disabled).
Time frame: 6 weeks
Numeric Rating Scale pain score
Change from baseline in self reported Numeric Rating Scale pain score at 6 weeks. Pain scale ranges from 0 (pain free) to 10 (max pain).
Time frame: 6 weeks