Clinical trial NCT05426356: Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
Official title: Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fracture;Pelvis
Sacral Fracture
Sacroiliac; Fusion
Fragility Fracture
Insufficiency Fractures
Osteoporosis
Keywords: Elderly
Fragility fracture
Pelvic fracture fixation
SI Joint Fusion
Non-surgical management
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-22
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).
timeFrame: 1 year
measure: 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).
timeFrame: 1 year
Secondary outcomes:
measure: Continuous Summary Physical Performance Score (CSPPS)
timeFrame: 1 year
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) physical function
timeFrame: 6 weeks
measure: Oswestry Disability Index
timeFrame: 6 weeks
measure: Numeric Rating Scale pain score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lincoln
country: United States
facility: Bryan Health Medical Center
state: Nebraska
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Wyomissing
country: United States
facility: Orthopedic Associates of Reading
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richland
country: United States
facility: Kadlec Clinic Northwest Orthopedic & Sports Medicine
state: Washington
Study officials:
affiliation: SI-BONE
name: Robyn Capobianco, PhD
role: STUDY_DIRECTOR
References: