Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture, Insufficiency Fractures, Osteoporosis
Conditions
Keywords
Elderly, Fragility fracture, Pelvic fracture fixation, SI Joint Fusion, Non-surgical management
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 insufficiency fractures
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. 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.
Interventions
DEVICESurgical Intervention
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.
Sponsors
SI-BONE, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects are randomized to sacral fracture fixation and SI joint fusion using iFuse-TORQ vs. non-surgical management (NSM). There is a crossover component for subjects who fail NSM.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 60 years of age at screening. 2. 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 3. Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral) 4. Patient is either bedbound or must use a wheelchair to cover distances more than 50ft 5. Prior to fracture, patient was able to ambulate using a cane or unassisted 6. Medically stable to undergo either surgical or non-surgical treatment of index fracture. 7. Patient is willing and able to provide written informed consent 8. Patient is mentally able to comply with study protocol requirements
Exclusion criteria
1. Patient requires surgery to address fracture in the pelvic ring (NSM not feasible) 2. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum 3. Sacral fracture potentially or definitely related to tumor 4. 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 5. History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium. 6. Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture 7. Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments 8. 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) 9. Known allergy to titanium or titanium alloys 10. Current local or systemic infection that raises the risk of surgery. 11. Known or suspected active drug or alcohol abuse, including opioids. 12. Patient lives or plans to move more than 100 miles from the site during the course of the study. 13. Current enrollment in another investigational clinical trial related to fractures or osteoporosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS). | 1 year | 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. |
| 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). | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Summary Physical Performance Score (CSPPS) | 1 year | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) physical function | 6 weeks | 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). |
| Oswestry Disability Index | 6 weeks | Change from baseline in self reported Oswestry Disability Index at 6 weeks. Calculated scores range from 0 (no disability) to 50 (completely disabled). |
| Numeric Rating Scale pain score | 6 weeks | 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). |
Countries
United States
Outcome results
None listed