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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05426356
Other study ID # 300900
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 18, 2022
Est. completion date January 2025

Study information

Verified date June 2024
Source SI-BONE, Inc.
Contact n/a
Is FDA regulated No
Health authority
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 Active, not 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

Study Design


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 Medical University of South Carolina Charleston South Carolina
United States University of Virginia Charlottesville Virginia
United States University of Chicago Chicago Illinois
United States Bryan Health Medical Center Lincoln Nebraska
United States Saint Barnabas Medical Center Livingston New Jersey
United States Kadlec Clinic Northwest Orthopedic & Sports Medicine Richland Washington
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
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