iFuse Implant System® Minimally Invasive Arthrodesis (iMIA)

• ClinicalTrials.gov Identifier: NCT01741025
• Recruitment Status: Completed
• First Posted: December 4, 2012
• Last Update Posted: October 3, 2017
• Sponsor: SI-BONE, Inc.
• Information provided by (Responsible Party): SI-BONE, Inc.

Tracking Information

• First Submitted Date: November 30, 2012
• First Posted Date: December 4, 2012
• Last Update Posted Date: October 3, 2017
• Study Start Date: June 2013
• Actual Primary Completion Date: December 15, 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 30, 2012): 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 [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 30, 2012)

• Change from baseline in lower back pain (VAS) [ Time Frame: 1, 3, 12 and 24 months ]
• Change from baseline in leg pain (VAS [ Time Frame: 1, 3, 6, 12 and 24 months ]
• Change in disability due to back pain (ODI [ Time Frame: 3, 6, 12 and 24 months ]
• Change in quality of life (EQ-5D [ Time Frame: 3, 6, 12 and 24 months ]
• Change in ambulatory and work status [ Time Frame: 1, 3, 6, 12 and 24 months ]
• Change in depression score (Zung Depression Scale [ Time Frame: 3, 6, 12 and 24 months ]
• Change in objective functional test (ASLR [ Time Frame: 3, 6, 12 and 24 months ]
• Change in walking distance [ Time Frame: 3, 6, 12 and 24 months ]
• Patient satisfaction and self-rating of disease state [ Time Frame: 3, 6, 12 and 24 months ]
• Serious adverse events [ Time Frame: during 24 months ]
• Device breakage, loosening and migration [ Time Frame: 12 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: November 30, 2012): Surgical re-interventions of target SI joint(s) [ Time Frame: over 24 months ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: iFuse Implant System® Minimally Invasive Arthrodesis
• Official Title: A Multicenter Randomized Controlled Post-market Clinical Follow-up Trial Comparing the Effectiveness and Safety of the iFuse Implant System® Versus Conservative Management for Patients With Chronic, Disabling SI Joint Pain.
• 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
• Detailed Description: This study is a multicenter randomized controlled, post-market clinical follow-up clinical trial of the iFuse Implant System for SI joint fusion vs. conservative management. Subjects assigned to conservative management may cross over to iFuse after a minimum of 6 months of conservative treatment. Conservative management does not include interventional procedures such as prolotherapy, steroid injections and/or RF ablation.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sacroiliac Joint Pain

Intervention

• Device: iFuse Implant System
  Placement of iFuse implant system via surgery
• Other: Conservative Management
  Medications for pain, physical therapy, cognitive behavour therapy

Study Arms

• Experimental: iFuse Implant System
  Surgical placement of iFuse implants in the affected SI joint
  Intervention: Device: iFuse Implant System
• Active Comparator: conservative management
  Medications, physical therapy, information
  Intervention: Other: Conservative Management

Publications *

• 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.
• 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. Epub 2016 Sep 15.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 30, 2017): 103
• Original Estimated Enrollment (submitted: November 30, 2012): 100
• Actual Study Completion Date: September 24, 2017
• Actual Primary Completion Date: December 15, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age 21-70 at time of screening
2. Patient has lower back pain for >6 months or >18 months for pregnancy induced lower back pain
3. 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)
4. Baseline Oswestry Disability Index (ODI) score of at least 30%
5. Baseline lower back pain score of at least 50 on 0-100 point VAS
6. Patient has signed study-specific informed consent form
7. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria:

1. 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
2. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
3. 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.
4. Spine surgery during the past 12 months.
5. Previously diagnosed or suspected osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture)
6. Documented osteomalacia or other metabolic bone disease
7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
8. Known allergy to titanium or titanium alloys
9. Use of medications known to have detrimental effects on bone quality and soft-tissue healing
10. Prominent neurologic condition that would interfere with physical therapy
11. Current systemic infection or local infection at the SI joint
12. Currently pregnant or planning pregnancy in the next year
13. Known or suspected drug or alcohol abuse
14. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
15. Patient is participating in an investigational study or has been involved in an investigational study within 3 months of surgery

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Germany, Italy, Sweden

Administrative Information

• NCT Number: NCT01741025
• Other Study ID Numbers: 300134
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: SI-BONE, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: SI-BONE, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Daniel Cher; SI-BONE, Inc.

• PRS Account: SI-BONE, Inc.
• Verification Date: September 2017