iFuse Implant System® Minimally Invasive Arthrodesis

NCT01741025 | Completed

• 1 other identifier: 300134
• Study Type: interventional
• Target: 103
• Locations: 4 countries
• Sites: 9

Brief Summary

The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint

Conditions

Sacroiliac Joint Pain

Outcome Measures

Primary Outcomes (1)

• The change in lower back pain as rated by the study subject using a 0-100 visual analog scale (VAS) at 6 months after initiation of treatment

  6 months

Secondary Outcomes (11)

• Change from baseline in lower back pain (VAS)

  1, 3, 12 and 24 months

• Change from baseline in leg pain (VAS

  1, 3, 6, 12 and 24 months

• Change in disability due to back pain (ODI

  3, 6, 12 and 24 months

• Change in quality of life (EQ-5D

  3, 6, 12 and 24 months

• Change in ambulatory and work status

  1, 3, 6, 12 and 24 months

Other Outcomes (1)

• Surgical re-interventions of target SI joint(s)

  over 24 months

Study Arms (2)

iFuse Implant System

EXPERIMENTAL

Surgical placement of iFuse implants in the affected SI joint

Device: iFuse Implant System

conservative management

ACTIVE COMPARATOR

Medications, physical therapy, information

Other: Conservative Management

Interventions

iFuse Implant System DEVICE

Placement of iFuse implant system via surgery

iFuse Implant System

Conservative Management OTHER

Medications for pain, physical therapy, cognitive behavour therapy

conservative management

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-70 at time of screening
• Patient has lower back pain for \>6 months or \>18 months for pregnancy induced lower back pain
• Diagnosis of the SI joint as the primary lower back pain generator based on ALL of the following: a. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and b. Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain, and c. Patient has improvement in lower back pain NRS of at least 50% of the pre injection NRS score after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test \<6 months ago)
• Baseline Oswestry Disability Index (ODI) score of at least 30%
• Baseline lower back pain score of at least 50 on 0-100 point VAS
• Patient has signed study-specific informed consent form
• Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

You may not qualify if:

• Severe lower 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
• Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
• History of recent (\<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring.
• Spine surgery during the past 12 months.
• Previously diagnosed or suspected osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture)
• Documented osteomalacia or other metabolic bone disease
• Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
• Known allergy to titanium or titanium alloys
• Use of medications known to have detrimental effects on bone quality and soft-tissue healing
• Prominent neurologic condition that would interfere with physical therapy
• Current systemic infection or local infection at the SI joint
• Currently pregnant or planning pregnancy in the next year
• Known or suspected drug or alcohol abuse
• Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
• Patient is participating in an investigational study or has been involved in an investigational study within 3 months of surgery

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (9)

OLV Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

La Clinique de l'Espérance

Montegnée, 4420, Belgium

Location

Charité - Universitätsmedizin Berlin

Berlin, 12200, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Praxisgemeinschaft "Leben in Bewegung"

Hilden, 40721, Germany

Location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Ospedale Civile Di Legnano

Legnano, 20025, Italy

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Aleris Specialistvård Ängelholm, Ortopedkliniken

Ängelholm, 26262, Sweden

Location

Related Publications (4)

• Dat KO, Cher D, Polly DW. Effects of BMI on SI joint fusion outcomes: examining the evidence to improve insurance guidelines. Spine J. 2024 May;24(5):783-790. doi: 10.1016/j.spinee.2023.11.015. Epub 2023 Dec 9.

  PMID: 38081463 DERIVED

• Dengler JD, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Gaetani P, van Eeckhoven E, Cher D, Sturesson B. 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain. Pain Physician. 2017 Sep;20(6):537-550.

  PMID: 28934785 DERIVED

• Dengler J, Sturesson B, Kools D, Prestamburgo D, Cher D, van Eeckhoven E, Erk E, Pflugmacher R, Vajkoczy P; the iMIA study group. Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial. Acta Neurochir (Wien). 2016 Nov;158(11):2219-2224. doi: 10.1007/s00701-016-2953-7. Epub 2016 Sep 15.

  PMID: 27629371 DERIVED

• Sturesson B, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Dengler J. Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management. Eur Spine J. 2017 Mar;26(3):708-719. doi: 10.1007/s00586-016-4599-9. Epub 2016 May 14.

  PMID: 27179664 DERIVED

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Daniel Cher

  SI-BONE, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: June 1, 2013
• Primary Completion: December 15, 2015
• Study Completion: September 24, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

BE (2); IT (3); DE (3); SE (1)