Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Osteoporosis Clinical Trial

— SAFFRON  

Official title:

Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426356
• Other study ID #: 300900
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2022
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: SI-BONE, Inc.
• Contact: Khanha Taheri, MPH
• Phone: (408) 207-0700
• Email: saffron[@]si-bone.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Stress
• Fragility Fracture
• Insufficiency Fractures
• Osteoporosis
• Sacral Fracture
• Sacroiliac; Fusion

Intervention

Device:
• Surgical Intervention
Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ

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

Locations

Country	Name	City	State
United States	TRIA Orthopedics, Mpls MN	Bloomington	Minnesota
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	UC Davis Department of Orthopaedic Surgery	Davis	California
United States	Memorial Hermann	Houston	Texas
United States	Bryan Health Medical Center	Lincoln	Nebraska
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania
United States	Kadlec Clinic Northwest Orthopedic & Sports Medicine	Richland	Washington
United States	Baylor Scott and White Research Institute	Temple	Texas
United States	Orthopedic Associates of Reading	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
SI-BONE, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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