Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Not Applicable

Terminated

• Conditions: Fragility Fracture; Sacroiliac; Fusion; Fracture;Pelvis; Osteoporosis; Sacral Fracture; Insufficiency Fractures
• Interventions: Device: Surgical Intervention; Other: Non-Surgical Management

• Registration Number: NCT05426356
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-22
• Study Start: 2022-09-18
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Treatment	Surgical Intervention	Surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint
Non-Surgical Treatment	Non-Surgical Management	Non-surgical management (NSM) of sacral insufficiency or fragility fractures (SFIF)

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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).
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).
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).

Trial Locations

Locations (7)

Kadlec Clinic Northwest Orthopedic & Sports Medicine; 🇺🇸 Richland, Washington, United States

Bryan Health Medical Center; 🇺🇸 Lincoln, Nebraska, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Saint Barnabas Medical Center; 🇺🇸 Livingston, New Jersey, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Orthopedic Associates of Reading; 🇺🇸 Wyomissing, Pennsylvania, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States