2-year Results (Bornemann - Technol Health Care 2017) | SI-BONE

Clinical Data

2-year Results (Bornemann - Technol Health Care 2017)

Two-year Clinical Results of Patients with Sacroiliac Joint Syndrome Treated by Arthrodesis Using A Triangular Implant System

Bornemann R, Roessler PP, Strauss AC, Sander K, Rommelspacher Y, Wirtz DC, Pflugmacher R, Frey SP.
Technol Health Care. 2017;25(2):319-325.  DOI: 10.3233/THC-161272


Background: Sacroiliac joint (SIJ) syndrome can cause various symptoms and may also be one reason for persistent low back pain, especially in patients with prior spinal fusions. If conservative treatments fail to improve symptoms, arthrodesis surgery can be considered. Minimally invasive approaches have emerged recently providing a good alternative to conventional methods. A novel triangular implant system (iFuse) can achieve an arthrodesis of the SIJ without the use of additional screws or bone material.

Objective: Aim of the present study was an evaluation of short-term safety and efficacy of the implant system.

Methods: Twenty-four patients were included in the study and treated with the iFuse system. In addition to demographic data, pain intensity (visual analogue scale) and functional impairment (Oswestry-disability index) were assessed prior to surgery and 1 month, 3 months, 6 months, 12 months and 24 months thereafter. During surgery and the follow up period all adverse events were documented and the correct implant position was controlled via plain radiographs.

Results: VAS scores and ODI improved significantly directly after surgery from 84.3 ± 9.2 mm to 40.7 ± 9.2 mm and from 76.8 ± 9.2% to 40.7 ± 9.2 % (p < 0.001). The ODI improved further to 31 ± 5.4% after 24 months whereas the VAS improved until the 3 months examination and ten stayed constant between 27.7 mm and 26.5 mm to 27 ± 6.6 mm at 24 months. No adverse events, intraoperative complications, implant malpositioning or loosening could be recorded at any time.

Conclusions: The iFuse system is an effective and safe treatment for minimally invasive surgical arthrodesis of the SIJ. Pain and functional impairment can be significantly improved. However, in addition to this case series, further controlled studies are necessary, particularly in terms of a previous spinal fusion history.

KEYWORDS: Sacroiliac joint (SIJ) syndrome; arthrodesis; minimal invasive implant

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