Trial record 2 of 5 for:    si-bone

iFuse Implant System® Minimally Invasive Arthrodesis (iMIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.
ClinicalTrials.gov Identifier:
NCT01741025
First received: November 30, 2012
Last updated: May 18, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention
Sacroiliac Joint Pain
Device: iFuse Implant System
Other: Conservative Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by SI-BONE, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in lower back pain (VAS) [ Time Frame: 1, 3, 12 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in leg pain (VAS [ Time Frame: 1, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in disability due to back pain (ODI [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in quality of life (EQ-5D [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in ambulatory and work status [ Time Frame: 1, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in depression score (Zung Depression Scale [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in objective functional test (ASLR [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Change in walking distance [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Patient satisfaction and self-rating of disease state [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: during 24 months ] [ Designated as safety issue: Yes ]
  • Device breakage, loosening and migration [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Surgical re-interventions of target SI joint(s) [ Time Frame: over 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iFuse Implant System
Surgical placement of iFuse implants in the affected SI joint
Device: iFuse Implant System
Placement of iFuse implant system via surgery
Active Comparator: conservative management
Medications, physical therapy, information
Other: Conservative Management
Medications for pain, physical therapy, cognitive behavour therapy

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741025

Locations
Belgium
OLV Ziekenhuis Aalst
Aalst, Belgium, 9300
La Clinique de l'Espérance
Montegnée, Belgium, 4420
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12200
Universitätsklinikum Bonn
Bonn, Germany, 53127
Praxisgemeinschaft "Leben in Bewegung"
Hilden, Germany, 40721
Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Ospedale Civile Di Legnano
Legnano, Italy, 20025
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sweden
Aleris Specialistvård Ängelholm, Ortopedkliniken
Ängelholm, Sweden, 26262
Sponsors and Collaborators
SI-BONE, Inc.
Investigators
Study Director: Daniel Cher SI-BONE, Inc.
  More Information

No publications provided

Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT01741025     History of Changes
Other Study ID Numbers: 300134
Study First Received: November 30, 2012
Last Updated: May 18, 2015
Health Authority: Italy: Ethics Committee
Sweden: Regional Ethical Review Board
Germany: Ethics Commission
Belgium: Ethics Committee

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2015