Sacral Fracture Fusion/Fixation for Rapid Rehabilitation (SAFFRON)

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

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khanha Taheri, MPH; Phone Number: (408) 207-0700; Email: saffron@si-bone.com

Study Locations

• United States
  • California
    • Davis, California, United States, 95817
      • Withdrawn
      • UC Davis Department of Orthopaedic Surgery
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Alexis Robinson-Dear
      • Principal Investigator: Jason Strelzow, MD
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Withdrawn
      • TRIA Orthopedics, Mpls MN
  • Nebraska
    • Lincoln, Nebraska, United States, 68501
      • Recruiting
      • Bryan Health Medical Center
      • Contact: Bobbi Clinch
      • Principal Investigator: Steven F Shannon, MD
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Recruiting
      • Saint Barnabas Medical Center
      • Contact: Ian Hong
      • Principal Investigator: Richard Yoon, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Withdrawn
      • Allegheny Singer Research Institute
    • Wyomissing, Pennsylvania, United States, 19610
      • Recruiting
      • Orthopedic Associates of Reading
      • Contact: Kristen Goshert
      • Principal Investigator: Ryan Michels, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Gabby Rivera
      • Principal Investigator: Kristoff Reid, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Withdrawn
      • Memorial Hermann
    • Temple, Texas, United States, 76508
      • Withdrawn
      • Baylor Scott and White Research Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Eric McVey
      • Principal Investigator: Michael Hadeed, MD
  • Washington
    • Richland, Washington, United States, 99352
      • Recruiting
      • Kadlec Clinic Northwest Orthopedic & Sports Medicine
      • Contact: Carlee Abel
      • Principal Investigator: John David Black, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-Surgical Treatment; Non-surgical management (NSM) of sacral insufficiency or fragility fractures (SFIF)	Other: Non-Surgical Management; Non-surgical management (NSM) is any treatment deemed appropriate for the subject that does not involve surgery.
Experimental: Surgical Treatment; Surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint	Device: Surgical Intervention; Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	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).	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.	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	6 weeks
Oswestry Disability Index	Change from baseline in self reported Oswestry Disability Index at 6 weeks. Calculated scores range from 0 (no disability) to 50 (completely disabled).	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).	6 weeks

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.
• Investigators: Study Director: Robyn Capobianco, PhD, SI-BONE

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Fragility fracture; Pelvic fracture fixation; SI Joint Fusion; Non-surgical management
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Fractures, Bone; Osteoporosis; Fractures, Stress
• Other Study ID Numbers: 300900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes