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SIJ surgery

The missing therapeutical link?

Since 2009 many new SIJ fusion systems were presented which raise huge expectations for the medical device industry and for patients. SIMEG is not recommending or prefering any technique, efficacy needs to be approved by appropriate clinical studies (see our study page). The development of an international register to collect the product features is discussed. Basically there are three SIJ fusion principles:

1. Posterolateral approach: Mechanical primary stabilization utilizing one or more percutanous, transgluteal screws or dowels transfixing the ilial and sacral bone for secondary arthrodesis.

 

 

2. Posterior approach: Transfixing dorsolateral technique like (1) with or without additional bonegrafting.

3. Posteromedial: Distraction of the joint space and realignment of the dislocated articular surfaces. Primary fusion with temporary mechanical immobilisation in mini-open technique via a posterior midline approach. 

Non-surgical treatment is mandadory prior to considering surgery. A consensus about the definition 'end of therapy' should be found.

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The information below was provided by the MD manufacturers, latest update 2014/03. An update on this is to be expected after the ICSJS 2018 in February 2018.

Overview of actcual surgical procedures

Manufacturer Product Description Principle Bonegraft Option FDA approved CE certified since/active in case number
SI-Bone Ifuse® Implant System Porouscoated Triangular Dowel transgluteal fixation, percutanous no yes, 510 K yes 2008/USA; EU 15.000
Zyga Technology Simmetry® Hollow screw, HA coated transgluteal fixation, percutanous yes yes, 510 K not known 2011/USA not known
GLOBUS Medical SI-Lok® Hollow screw, HA coated transgluteal fixation, percutanous yes yes, 510 K yes 2012/USA/2014/DE, UK, S, DK, BE 100+ (DE)
X-Tant SILEX® Hollow screw, HA coated transgluteal fixation, percutanous yes yes, 510 K yes 2012/D, AT, UK, BE, E, IT, TK, S, DK, US, MEX 2.200
Orthofix SAMBA® Hollow screw, titanium transgluteal fixation, percutanous yes yes, 510 K not known 2013/USA not known
SpineFrontier, Inc. SIJ-Fuse Screw cannulated screw mechanical stabilization, transfixing yes yes, 510 K no end 2015 not known
SpineFrontier, Inc. SIJ-Fuse Rod cannulated rod with porometal core mechanical stabilization, transfixing no yes, 510 K no end 2015 not known
Zimmer TriCor (identical with SILEX?) Hollow screw, HA coated transgluteal fixation, mini open yes yes, 510 K not known not known not known
Manufacturer Product Description Principle Bonegraft Option FDA approved CE certified since/active in case number
SI-Technology SI-Desis Distraction implant not known not known not known not known 2014/not known not known
TENON Medical patent application only Distraction implant not known not known not known not known 2014 not known
Medtronic SI-Fix; re-branded as RIALTO porometal cannulated screw mechanical stabilization, transfixing yes yes not known 2014/USA not known
SpineFrontier, Inc. SIJ-Fuse Screw cannulated screw mechanical stabilization, transfixing yes yes, 510 K no end 2015 not known
SpineFrontier, Inc. SIJ-Fuse Rod cannulated rod with porometal core mechanical stabilization, transfixing no yes, 510 K no end 2015 not known
Manufacturer Product Description Principle Bonegraft Option FDA approved CE certified since/active in case number
SIGNUS DIANA® Distraction arthrodesis mini open, realignment, fusion yes no yes 2009/DE, AT, CH, PL, UK, ZA, MY, MEX, AUS, S, IT 2.500
Osteon BV/MAXXSPINE Transmaxx Bolt single piece distraction implant mini-open, stepless distraction yes no yes deactivated, product withdrawn 120
VG Innovations SI-Join Distraction spacer MIS, perkutanous, distraction yes yes not known 2014/USA not known
NuTech Spine SI-Fix Bone Block Bone dowel MIS, percutanous/mini open, distraction, Fusion yes not required no 2013/USA not known
Ilionmedical NADIA® Distraction arthrodesis mini open, realignment, fusion yes no exp. 2016-09 not known not known