iFuse Implant System® Minimally Invasive Arthrodesis

Sacroiliac Joint Pain Clinical Trial

— iMIA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741025
• Other study ID #: 300134
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: September 30, 2017
• Start date: June 2013
• Est. completion date: September 24, 2017

Study information

• Verified date: September 2017
• Source: SI-BONE, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 24, 2017
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• 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

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis Aalst	Aalst
Belgium	La Clinique de l'Espérance	Montegnée
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Praxisgemeinschaft "Leben in Bewegung"	Hilden
Italy	Istituto Ortopedico Rizzoli	Bologna
Italy	Ospedale Civile Di Legnano	Legnano
Italy	IRCCS Policlinico San Matteo	Pavia
Sweden	Aleris Specialistvård Ängelholm, Ortopedkliniken	Ängelholm

Sponsors (1)

Lead Sponsor	Collaborator
SI-BONE, Inc.

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical re-interventions of target SI joint(s)		over 24 months
Primary	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	Change from baseline in lower back pain (VAS)		1, 3, 12 and 24 months
Secondary	Change from baseline in leg pain (VAS		1, 3, 6, 12 and 24 months
Secondary	Change in disability due to back pain (ODI		3, 6, 12 and 24 months
Secondary	Change in quality of life (EQ-5D		3, 6, 12 and 24 months
Secondary	Change in ambulatory and work status		1, 3, 6, 12 and 24 months
Secondary	Change in depression score (Zung Depression Scale		3, 6, 12 and 24 months
Secondary	Change in objective functional test (ASLR		3, 6, 12 and 24 months
Secondary	Change in walking distance		3, 6, 12 and 24 months
Secondary	Patient satisfaction and self-rating of disease state		3, 6, 12 and 24 months
Secondary	Serious adverse events		during 24 months
Secondary	Device breakage, loosening and migration		12 months