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iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

Primary Purpose

Sacroiliac Joint Dysfunction, Sacroiliac; Fusion, Sacroiliac Disorder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Use of iFuse TORQ
Sponsored by
SI-BONE, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint Dysfunction

Eligibility Criteria

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

Inclusion Criteria: Age > 21 at time of screening Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption) Baseline Oswestry Disability Index (ODI) score of at least 30% Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale BMI < 35 Patient has signed study-specific informed consent form Exclusion Criteria: ASA score 4 or 5 Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture Cluneal neuralgia Previous SIJ implant placement, including allograft Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement History of recent (<1 year) major trauma to pelvis Previously diagnosed or suspected severe osteoporosis (defined as prior T-score < -2.5 or history of osteoporotic fracture). Chronic rheumatologic condition (e.g., rheumatoid arthritis) Current diagnosis of fibromyalgia Known allergy to titanium or titanium alloys Current local or systemic infection that raises the risk of surgery Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation Currently pregnant or planning pregnancy in the next 2 years (self-reported) Patient is a prisoner or a ward of the state. Known or suspected active drug or alcohol abuse, including opioids Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation Currently participating in another interventional clinical trial

Sites / Locations

  • Total Spine InstituteRecruiting
  • Napa Valley OrthopaedicsRecruiting
  • Source HealthcareRecruiting
  • Ascentist HealthcareRecruiting
  • University of KentuckyRecruiting
  • Clearway PainRecruiting
  • iSpineRecruiting
  • St Louis Pain ConsultantsRecruiting
  • Nevada Advanced PainRecruiting
  • Clinical InvestigationsRecruiting
  • Neurological Associates of LancasterRecruiting
  • Northwest Pain CareRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Use of iFuse TORQ for SI Joint Fusion

Arm Description

Participants with SI joint dysfunction are treated with iFuse TORQ.

Outcomes

Primary Outcome Measures

Change in SI joint pain measured by numerical rating scale (NRS)
Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable)

Secondary Outcome Measures

Improvement from baseline in SI joint (SIJ) pain
Improvement from baseline in SIJ pain as measured by numeric rating scale (0- no pain to 10- worst pain imaginable).
Improvement from baseline in disability
Improvement from baseline in disability as measured by Oswestry Disability Index
Improvement from baseline in quality of life
Improvement from baseline in aggregate quality of life and individual domains as measured by PROMIS-29.
Proportion of subjects with a complication rated as probably or definitely related to the procedure or device.
Evidence of bone binding
Evidence of bone binding to at least 50% of the porous surface area of each implanted device
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation, as evidenced by both radiopaque areas around implant plus bony reaction ("rind") near implant
Proportion of iFuse TORQ implants that show evidence of device migration
Proportion of iFuse TORQ implants that show breakage

Full Information

First Posted
May 12, 2023
Last Updated
September 15, 2023
Sponsor
SI-BONE, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05870488
Brief Title
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
Official Title
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.
Detailed Description
STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. The goal of the study is to demonstrate the effectiveness of the device for its intended use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Dysfunction, Sacroiliac; Fusion, Sacroiliac Disorder, Sacroiliac Joint Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Use of iFuse TORQ for SI Joint Fusion
Arm Type
Other
Arm Description
Participants with SI joint dysfunction are treated with iFuse TORQ.
Intervention Type
Device
Intervention Name(s)
Use of iFuse TORQ
Intervention Description
Use of iFuse TORQ for the treatment of SI Joint dysfunction
Primary Outcome Measure Information:
Title
Change in SI joint pain measured by numerical rating scale (NRS)
Description
Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable)
Time Frame
At baseline and 6 months
Secondary Outcome Measure Information:
Title
Improvement from baseline in SI joint (SIJ) pain
Description
Improvement from baseline in SIJ pain as measured by numeric rating scale (0- no pain to 10- worst pain imaginable).
Time Frame
At baseline, 1-, 3-, 6-, 12-, and 24-months
Title
Improvement from baseline in disability
Description
Improvement from baseline in disability as measured by Oswestry Disability Index
Time Frame
At baseline, 1-, 3-, 6-, 12-, and 24-months
Title
Improvement from baseline in quality of life
Description
Improvement from baseline in aggregate quality of life and individual domains as measured by PROMIS-29.
Time Frame
At baseline, 1-, 3-, 6-, 12-, and 24-months
Title
Proportion of subjects with a complication rated as probably or definitely related to the procedure or device.
Time Frame
At baseline, 1-, 3-, 6-, 12-, and 24-months
Title
Evidence of bone binding
Description
Evidence of bone binding to at least 50% of the porous surface area of each implanted device
Time Frame
At baseline and 24 months
Title
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation
Description
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation, as evidenced by both radiopaque areas around implant plus bony reaction ("rind") near implant
Time Frame
At baseline and 24 months
Title
Proportion of iFuse TORQ implants that show evidence of device migration
Time Frame
At baseline and 24 months
Title
Proportion of iFuse TORQ implants that show breakage
Time Frame
At baseline and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 21 at time of screening Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption) Baseline Oswestry Disability Index (ODI) score of at least 30% Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale BMI < 35 Patient has signed study-specific informed consent form Exclusion Criteria: ASA score 4 or 5 Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture Cluneal neuralgia Previous SIJ implant placement, including allograft Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement History of recent (<1 year) major trauma to pelvis Previously diagnosed or suspected severe osteoporosis (defined as prior T-score < -2.5 or history of osteoporotic fracture). Chronic rheumatologic condition (e.g., rheumatoid arthritis) Current diagnosis of fibromyalgia Known allergy to titanium or titanium alloys Current local or systemic infection that raises the risk of surgery Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation Currently pregnant or planning pregnancy in the next 2 years (self-reported) Patient is a prisoner or a ward of the state. Known or suspected active drug or alcohol abuse, including opioids Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation Currently participating in another interventional clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robyn Capobianco, PhD
Phone
(408) 207-0700
Email
robyn.capobianco@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
Total Spine Institute
City
Calabasas
State/Province
California
ZIP/Postal Code
91302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Vasquez
First Name & Middle Initial & Last Name & Degree
Ryan Mattie, MD
Facility Name
Napa Valley Orthopaedics
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Porter
First Name & Middle Initial & Last Name & Degree
Jacqueline Weisbein, DO
Facility Name
Source Healthcare
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Davis, MD
First Name & Middle Initial & Last Name & Degree
Timothy Davis, MD
Facility Name
Ascentist Healthcare
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard LaRue
First Name & Middle Initial & Last Name & Degree
Jeffrey Foster, MD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Banfield
First Name & Middle Initial & Last Name & Degree
Chris Mallard, MD
Facility Name
Clearway Pain
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
June Redding
First Name & Middle Initial & Last Name & Degree
Charles Simmons, MD
Facility Name
iSpine
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Saathoff
First Name & Middle Initial & Last Name & Degree
Rano Faltas, MD
Facility Name
St Louis Pain Consultants
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olayinka Idowu
First Name & Middle Initial & Last Name & Degree
Anne Christopher, MD
Facility Name
Nevada Advanced Pain
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Logan Lorentzen
First Name & Middle Initial & Last Name & Degree
Denis Patterson, DO
Facility Name
Clinical Investigations
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Whiterby
First Name & Middle Initial & Last Name & Degree
Doug Beall, MD
Facility Name
Neurological Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Smith, MD
First Name & Middle Initial & Last Name & Degree
Jack Smith, MD
Facility Name
Northwest Pain Care
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Hill
First Name & Middle Initial & Last Name & Degree
John Hatheway, MD

12. IPD Sharing Statement

Learn more about this trial

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

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