Clinical trial NCT01741025: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Pain
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 103
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in lower back pain (VAS)
timeFrame: 1, 3, 12 and 24 months
measure: Change from baseline in leg pain (VAS
timeFrame: 1, 3, 6, 12 and 24 months
measure: Change in disability due to back pain (ODI
timeFrame: 3, 6, 12 and 24 months
measure: Change in quality of life (EQ-5D
timeFrame: 3, 6, 12 and 24 months
measure: Change in ambulatory and work status
timeFrame: 1, 3, 6, 12 and 24 months
measure: Change in depression score (Zung Depression Scale
timeFrame: 3, 6, 12 and 24 months
measure: Change in objective functional test (ASLR
timeFrame: 3, 6, 12 and 24 months
measure: Change in walking distance
timeFrame: 3, 6, 12 and 24 months
measure: Patient satisfaction and self-rating of disease state
timeFrame: 3, 6, 12 and 24 months
measure: Serious adverse events
timeFrame: during 24 months
measure: Device breakage, loosening and migration
timeFrame: 12 months
Other outcomes:
measure: Surgical re-interventions of target SI joint(s)
timeFrame: over 24 months
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Montegnée
country: Belgium
facility: La Clinique de l'Espérance
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Hilden
country: Germany
facility: Praxisgemeinschaft "Leben in Bewegung"
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Legnano
country: Italy
facility: Ospedale Civile Di Legnano
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Ängelholm
country: Sweden
facility: Aleris Specialistvård Ängelholm, Ortopedkliniken
Study officials:
affiliation: SI-BONE, Inc.
name: Daniel Cher
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.