Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

NCT ID: NCT05426356

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-18
• Study Completion Date: 2024-06-15

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.

Conditions

Fracture;Pelvis; Sacral Fracture; Sacroiliac; Fusion; Fragility Fracture; Insufficiency Fractures; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-Surgical Treatment

Non-surgical management (NSM) of sacral insufficiency or fragility fractures (SFIF)

Group Type: ACTIVE_COMPARATOR

Non-Surgical Management

Intervention Type: OTHER

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

Surgical Treatment

Surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint

Group Type: EXPERIMENTAL

Surgical Intervention

Intervention Type: DEVICE

Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ

Interventions

Surgical Intervention

Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ

Intervention Type: DEVICE

Non-Surgical Management

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SI-BONE, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robyn Capobianco, PhD

Role: STUDY_DIRECTOR

SI-BONE

Locations

University of Chicago

Chicago, Illinois, United States

Bryan Health Medical Center

Lincoln, Nebraska, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Orthopedic Associates of Reading

Wyomissing, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Virginia

Charlottesville, Virginia, United States

Kadlec Clinic Northwest Orthopedic & Sports Medicine

Richland, Washington, United States

Countries

United States

Other Identifiers

300900

Identifier Type: -

Identifier Source: org_study_id