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AzTrials

Sacroiliac Joint PainiMIANCT01741025

iFuse Implant System® Minimally Invasive Arthrodesis

A study testing iFuse Implant System and Conservative Management in people with Sacroiliac Joint Pain, run by SI-BONE, Inc. at 9 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Sacroiliac Joint Pain
What is being tested?
iFuse Implant System and Conservative Management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
9 sitesin 4 countries
Study dates
Jun 2013to 24 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

Germany3 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 12200

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Praxisgemeinschaft "Leben in Bewegung"

    Hilden, 40721

Other trials in Germany

Italy3 sites

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

  • Ospedale Civile Di Legnano

    Legnano, 20025

  • IRCCS Policlinico San Matteo

    Pavia, 27100

Other trials in Italy

Belgium2 sites

  • OLV Ziekenhuis Aalst

    Aalst, 9300

  • La Clinique de l'Espérance

    Montegnée, 4420

Other trials in Belgium

Sweden1 site

  • Aleris Specialistvård Ängelholm, Ortopedkliniken

    Ängelholm, 26262

Other trials in Sweden

About this study

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.

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

Read the 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.

Being tested
iFuse Implant System, Conservative Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iFuse Implant SystemDevice

    Placement of iFuse implant system via surgery

  • Conservative ManagementOther

    Medications for pain, physical therapy, cognitive behavour therapy

Study groups in NCT01741025
Study groupRoleWhat they receive
iFuse Implant SystemExperimentalSurgical placement of iFuse implants in the affected SI joint
Receives: Device: iFuse Implant System
conservative managementActive comparatorMedications, physical therapy, information
Receives: Other: Conservative Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

Secondary outcomes (11)

  1. Change from baseline in lower back pain (VAS)

    Measured: 1, 3, 12 and 24 months

  2. Change from baseline in leg pain (VAS

    Measured: 1, 3, 6, 12 and 24 months

  3. Change in disability due to back pain (ODI

    Measured: 3, 6, 12 and 24 months

  4. Change in quality of life (EQ-5D

    Measured: 3, 6, 12 and 24 months

  5. Change in ambulatory and work status

    Measured: 1, 3, 6, 12 and 24 months

  6. Change in depression score (Zung Depression Scale

    Measured: 3, 6, 12 and 24 months

  7. Change in objective functional test (ASLR

    Measured: 3, 6, 12 and 24 months

  8. Change in walking distance

    Measured: 3, 6, 12 and 24 months

  9. Patient satisfaction and self-rating of disease state

    Measured: 3, 6, 12 and 24 months

  10. Serious adverse events

    Measured: during 24 months

  11. Device breakage, loosening and migration

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startJun 2013
  3. Primary completion15 Dec 2015
  4. Study completion24 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741025
Sponsor's protocol ID
300134
Acronym
iMIA
Status last verified
Sep 2017
First submitted
30 Nov 2012
Last updated
3 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • Dat KO, Cher D, Polly DW. Effects of BMI on SI joint fusion outcomes: examining the evidence to improve insurance guidelines. Spine J. 2024 May;24(5):783-790. doi: 10.1016/j.spinee.2023.11.015. Epub 2023 Dec 9.

    PubMed 38081463

  • 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.

    PubMed 28934785

  • 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.

    PubMed 27629371

  • 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.

    PubMed 27179664

Questions about this trial

What is this clinical trial studying?

A study testing iFuse Implant System and Conservative Management in people with Sacroiliac Joint Pain, run by SI-BONE, Inc. at 9 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany, Italy, Belgium, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01741025, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.

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