Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

iFuse Implant System® Minimally Invasive Arthrodesis (iMIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741025
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date October 3, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT01741025 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE iFuse Implant System® Minimally Invasive Arthrodesis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sacroiliac Joint Pain
Intervention  ICMJE
  • Device: iFuse Implant System
    Placement of iFuse implant system via surgery
  • Other: Conservative Management
    Medications for pain, physical therapy, cognitive behavour therapy
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2017)
103
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
100
Actual Study Completion Date  ICMJE September 24, 2017
Actual Primary Completion Date December 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Italy,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741025
Other Study ID Numbers  ICMJE 300134
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SI-BONE, Inc.
Study Sponsor  ICMJE SI-BONE, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel Cher SI-BONE, Inc.
PRS Account SI-BONE, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP