Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Sponsors

Lead Sponsor: SI-BONE, Inc.

Source SI-BONE, Inc.
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.

Overall Status Not yet recruiting
Start Date 2022-08-01
Completion Date 2025-01-01
Primary Completion Date 2024-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
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
Secondary Outcome
Measure Time Frame
Continuous Summary Physical Performance Score (CSPPS) 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function 6 weeks
Oswestry Disability Index 6 weeks
Numeric Rating Scale pain score 6 weeks
Enrollment 120
Condition
Intervention

Intervention Type: Device

Intervention Name: Surgical Intervention

Description: Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ

Arm Group Label: Surgical Treatment

Intervention Type: Other

Intervention Name: Non-Surgical Management

Description: Non-surgical management (NSM) is any treatment deemed appropriate for the subject that does not involve surgery.

Arm Group Label: Non-Surgical Treatment

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

60 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Robyn Capobianco, PhD Study Director SI-BONE
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Non-Surgical Treatment

Type: Active Comparator

Description: Non-surgical management (NSM) of sacral insufficiency or fragility fractures (SFIF)

Label: Surgical Treatment

Type: Experimental

Description: Surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint

Acronym SAFFRON
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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.

Primary Purpose: Treatment

Masking: None (Open Label)

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