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Sacral Fracture Fusion/Fixation for Rapid Rehabilitation (SAFFRON)

Primary Purpose

Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Surgical Intervention

Non-Surgical Management

About this trial

This is an interventional treatment trial for Fracture;Pelvis focused on measuring Elderly, Fragility fracture, Pelvic fracture fixation, SI Joint Fusion, Non-surgical management

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 60 years of age at screening.
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
Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral)
Patient is either bedbound or must use a wheelchair to cover distances more than 50ft
Prior to fracture, patient was able to ambulate using a cane or unassisted
Medically stable to undergo either surgical or non-surgical treatment of index fracture.
Patient is willing and able to provide written informed consent
Patient is mentally able to comply with study protocol requirements

Exclusion Criteria:

Patient requires surgery to address fracture in the pelvic ring (NSM not feasible)
Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum
Sacral fracture potentially or definitely related to tumor
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
History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium.
Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture
Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments
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)
Known allergy to titanium or titanium alloys
Current local or systemic infection that raises the risk of surgery.
Known or suspected active drug or alcohol abuse, including opioids.
Patient lives or plans to move more than 100 miles from the site during the course of the study.
Current enrollment in another investigational clinical trial related to fractures or osteoporosis

Sites / Locations

UC Davis Department of Orthopaedic SurgeryRecruiting
University of ChicagoRecruiting
TRIA Orthopedics, Mpls MN
Bryan Health Medical CenterRecruiting
Saint Barnabas Medical CenterRecruiting
Allegheny Singer Research InstituteRecruiting
Orthopedic Associates of ReadingRecruiting
Medical University of South CarolinaRecruiting
Memorial Hermann
Baylor Scott and White Research InstituteRecruiting
University of VirginiaRecruiting
Kadlec Clinic Northwest Orthopedic & Sports MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-Surgical Treatment

Surgical Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

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).

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).

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).

Full Information

NCT ID

NCT05426356

First Posted

June 10, 2022

Last Updated

September 18, 2023

Sponsor

SI-BONE, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05426356

Brief Title

Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Acronym

SAFFRON

Official Title

Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 18, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SI-BONE, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Elderly, Fragility fracture, Pelvic fracture fixation, SI Joint Fusion, Non-surgical management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Non-Surgical Treatment

Arm Type

Active Comparator

Arm Description

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

Arm Title

Surgical Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Surgical Intervention

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Non-Surgical Management

Intervention Description

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

Primary Outcome Measure Information:

Title

Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).

Description

Time Frame

1 year

Title

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Continuous Summary Physical Performance Score (CSPPS)

Description

Time Frame

1 year

Title

Patient-Reported Outcomes Measurement Information System (PROMIS) physical function

Description

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).

Time Frame

6 weeks

Title

Oswestry Disability Index

Description

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

Time Frame

6 weeks

Title

Numeric Rating Scale pain score

Description

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).

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 60 years of age at screening. 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 Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral) Patient is either bedbound or must use a wheelchair to cover distances more than 50ft Prior to fracture, patient was able to ambulate using a cane or unassisted Medically stable to undergo either surgical or non-surgical treatment of index fracture. Patient is willing and able to provide written informed consent Patient is mentally able to comply with study protocol requirements Exclusion Criteria: Patient requires surgery to address fracture in the pelvic ring (NSM not feasible) Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum Sacral fracture potentially or definitely related to tumor 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 History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium. Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments 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) Known allergy to titanium or titanium alloys Current local or systemic infection that raises the risk of surgery. Known or suspected active drug or alcohol abuse, including opioids. Patient lives or plans to move more than 100 miles from the site during the course of the study. Current enrollment in another investigational clinical trial related to fractures or osteoporosis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Khanha Taheri, MPH

Phone

(408) 207-0700

saffron@si-bone.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robyn Capobianco, PhD

Organizational Affiliation

SI-BONE

Official's Role

Study Director

Facility Information:

Facility Name

UC Davis Department of Orthopaedic Surgery

City

Davis

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julia Y Martin

Phone

916-734-8175

First Name & Middle Initial & Last Name & Degree

Gilian Soles, MD

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexis Robinson-Dear

First Name & Middle Initial & Last Name & Degree

Jason Strelzow, MD

Facility Name

TRIA Orthopedics, Mpls MN

City

Bloomington

State/Province

Minnesota

ZIP/Postal Code

55431

Country

United States

Individual Site Status

Withdrawn

Facility Name

Bryan Health Medical Center

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68501

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bobbi Clinch

First Name & Middle Initial & Last Name & Degree

Steven F Shannon, MD

Facility Name

Saint Barnabas Medical Center

City

Livingston

State/Province

New Jersey

ZIP/Postal Code

07039

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ian Hong

First Name & Middle Initial & Last Name & Degree

Richard Yoon, MD

Facility Name

Allegheny Singer Research Institute

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Fetter

Phone

412-359-4856

First Name & Middle Initial & Last Name & Degree

Edward Westrick, MD

Facility Name

Orthopedic Associates of Reading

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristen Goshert

First Name & Middle Initial & Last Name & Degree

Ryan Michels, MD

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabby Rivera

First Name & Middle Initial & Last Name & Degree

Kristoff Reid, MD

Facility Name

Memorial Hermann

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Withdrawn

Facility Name

Baylor Scott and White Research Institute

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie McMeen

First Name & Middle Initial & Last Name & Degree

Daniel Stahl, MD

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric McVey

First Name & Middle Initial & Last Name & Degree

Michael Hadeed, MD

Facility Name

Kadlec Clinic Northwest Orthopedic & Sports Medicine

City

Richland

State/Province

Washington

ZIP/Postal Code

99352

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlee Abel

First Name & Middle Initial & Last Name & Degree

John David Black, MD

12. IPD Sharing Statement

Plan to Share IPD

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