IFuse Implant System (surgery)

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IFuse Implant System (surgery)

Postby SiWiz » Thu Mar 28, 2013 1:12 am

Disclaimer: the following information have been collected from publically available webpages and distributed brochures and the information is not validated by the manufacturer. Referred websites: http://www.si-bone.com; http://www.sijpain.com; search engines research for ‘IFuse’; ‘SI-bone’; ‘adverse events +sacrolia’; ‘adverse events +ifuse’

IFuse Minimally Invasive Sacroiliac Joint Surgery
Brand: IFuse®
System elements: Titanium alloy triangular implant, porous coated surface for bony ontgrowth, guided instruments
Production and distribution: SI-BONE, Inc.
CE-certified: YES
FDA-approved: YES

Conceptor: Mark Reiley, M.D.
Concept: Minimal invasive percutaneous transilial fixation
Indications: sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis
Surgical approach: posterolateral percutaneous, transgluteal, transilial

Pros: Extremely solid implants with mechanical strength, primary mechanical stability, osteoconductive surface for bony ongrowth, stabilization follows known traumasurgical technique, short surgical time, short hospital stay (1 – 2 days),
Cons: SIJ should be realigned manually before surgery (discussed); several implants (2 - 3 min.) required; limited space for implant placement; no provision for bone grafting; poor intraoperative imaging of nerve roots and vessels (like SGA); Revision surgery often involves chiseling out implants (if bony ongrowth is realized in the ilial, but not in the sacral bone)

Clinical use since: 2008

Clinical study: Yes, obervational
    Estimated Enrollment: 250
    Study Start Date: July 2012
    Estimated Study Completion Date: September 2014
    Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Total cases: >5,500 worldwide, mainly in USA
Complications: Nerve and vascular injury, post op leg pain, implant loosening
Revision rate: Not known

Scientific support:
Medical advisory board
Sales concept:
Surgeons trained:
Total users:
USA, Germany, Switzerland, Italy
Website: http://www.si-bone.com
Patient testimonials: YES, website

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