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Current SIJ trials

Overview and proposals

Literature shows very few clinical SIJ fusion trials until 2012. There seems to be a lack of common sense within the medical community about the pain generator and appropriate therapies – particularly for preoperated and chronic  pain patients. Therefore a standardized study protocol could not yet be developed.

Randomized comparative studies of surgical methods are required. Premise: availability of a reference procedure. Medical device industry initiated some single-arm studies (single- or multicentered), and also some randomized studies have been started using non surgical therapies as a 2nd arm. The following overview was taken from clinicaltrials.gov as well as publically available information (no responsibility is taken for the correctness of this information):

IFuse® is a registered trademark of SI-Bone, Inc.

Trial 1 Trial 2 Trial 3 Trial 4
Device/Procedure: Ifuse® Implant System Ifuse® Implant System Ifuse® Implant System Ifuse® Implant System
Arm: single 2-arms: surgical ./. non surgical 2-arms: surgical ./. non surgical single
Status: active, not recruiting active, not recruiting active, not recruiting Recruiting
Est. completion date: Sept. 2014 Nov. 2014 Dec. 2015 Jan. 2019
Centers: 19 27 3 2
Nations involved: USA USA Germany/Sweden/Italy USA
FU period: 24 months 24 months 24 months 5 years
Enrolled patients: 250 200 100 225
Design: observation, prospective randomized, prospective randomized, prospective observation
Age: 21 - 70 years 21 - 70 years 21 - 70 years 21 - 70 years
Outcome: case study, pain reduction compare success compare success safety and efficacy
Publication: not known not known not known not known

SIJ-Fusion with Ifuse Implant System (SIFI); The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint). 

 

Outcome:

Improvement in SIJ pain, back dysfunction, ODI, quality of life, QOL (SF 36), work status, serious adverse events (ISO 14155:2011 definition)

Official Title:  INSITE Investigation of Sacroiliac Fusion Treatment

 

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

Primary Outcome Measures: Subject Success, Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention.

 

 

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

 

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 

Secondary Outcome Measures: Change from baseline in lower back pain (VAS) and leg pain (VAS, in disability due to back pain (ODI),  in quality of life (EQ-5D), in ambulatory and work status, in depression score (Zung Depression Scale), Change in objective functional test (ASLR), 

Patient satisfaction and self-rating of disease state,Serious adverse events, Device breakage, loosening and migration

Other Outcome Measures: Surgical re-interventions of target SI joint(s) 

The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).

Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). 

Outcome:

improvement in VAS (Visual Analog Scale), Sacroiliac (SI) joint joint pain by ≥20 mm, Absence of device-related SAE (Serious Adverse Events), Absence of neurological worsening, Absence of surgical re-intervention on the target SI joint(s), Improvement in VAS (Visual Analog Scale), SI joint pain, ODI, QOL, LOIS, SAE (occurence reate of SAE)

 

 

DIANA® is a registered trademark of SIGNUS Medizintechnik GmbH.

Trial 1
Device/Procedure: DIANA® Disctraction-Arthrodesis
Arm: single
Status: completed
Est. completion date: Sept. 2014
Centers: 20
Nations involved: Germany
FU period: 24 months
Enrolled patients: 200
Design: observation, prospective
Age: 21 - 70 years
Outcome: case study, pain reduction
Publication: German Spine Dec. 2014

Multicenter observation study, prospective, non-randomized post market study designed to collect data on SI joint fusion,

Outcome:

improvement of back- and leg pain reduction, quality of life, work status following implant of the DIANA device. ODI, MVAS, SF12, McGill, pre-/post, 3, 6, 12, 24 m; absence of adverse events; radiographic verification of bone healing and fusion

 

Simmetry® is a registered trademark of Zyga Technology, Inc.

Trial 1 Trial 2
Device/Procedure: Simmetry® Simmetry®
Arm: single single
Status: recruiting recruiting
Est. completion date: Dec. 2016 March 2017
Centers: 1 10
Nations involved: USA USA
FU period: 24 months 24 months
Enrolled patients: 15 50
Design: observation, prospective observation, prospective
Age: >18 years >18 years
Ziel: case study, pain reduction pain reduction; intraarticular fusion
Publication: not known not known

Trial 1

 

prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 24 months.)

Outcome:

intraarticular fusion, pain reduction

 

 

Trial 2

prospective, non-randomized post market study designed to collect data on SI joint fusion and subject back pain following implant of the SImmetry device.

Outcome:

SIJ Fusion: Confirmed fusion of the SI joint at 12 and 24 months, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium; SIJ Pain Reduction: evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 12 and 24 months

SI-Lok® is a registered trademark of Globus Medical, Inc.

Trial 1
Device/Procedure: SI-Lok®
Arm: single
Status: recruiting
Est. completion date: Dec. 2016
Centers: 4
Nations involved: USA
FU period: 24 months
Enrolled patients: 55
Design: observation, prospective
Age: 21 - 70 years
Outcome: case study, pain reduction, confirmed fusion
Publication: not known

The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction. The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.

Outcome:

Radiographic Evaluation, Fusion Assessment Radiolucency; Hospitalization Data: Operative Time, Blood Loss, Blood Transfusion, Hospitalization Time; Back and Leg Pain, Measured by Visual Analog Scale, Oswestry Disability Index (ODI), Patient Satisfaction