1-year Results, 24 patients (Bornemann - Z Orthop Unfall 2016)

Clinical Trial to Test the iFuse Implant System® in Patients with Sacroiliac Joint Syndrome: One Year Results [in German]

Bornemann R, Webler M, Koch EM, Dengler J, Wirtz DC, Frey SP.
Z Orthop Unfall. 2016 Dec;154(6):601-605. [Epub 2016 Jul 7]. Article in German. DOI: 10.1055/s-0042-110207

ABSTRACT

Background: This study reports one year post-operative monitoring of the efficacy and safety of iFuse Implant System® in patients with sacroiliac joint syndrome.

Material and Methods: After 6 months of inadequate conservative treatment, patients with properly proven ISG syndrome were selected for surgery. The iFuse implants had a triangular profile and coating of porous titanium plasma spray and were used in the minimally invasive procedures. The procedure was performed under general anaesthesia and fluoroscopic control. In each case, three implants were placed.

Results: 24 patients (22 f; 92 %; 54.9 ± 14 years) participated in the study. The operations were performed in 11 patients (46 %) on the left and in 13 patients (54 %) on the right. The mean operative time was 42.4 minutes (95 % CI: 35.6-49.3). The reduction in pain intensity on the VAS scale was 58 ± 11 mm (68 ± 7 %). The Oswestry score showed a median decrease of 44 percentage points (57 %). After 12 months, 15 patients (63 %) reported that they were taking no more painkillers.

Conclusion: The minimally invasive treatment of patients with sacroiliac joint syndrome using the iFuse Implant System leads to significant analgesic effects over the period of one year; it also contributes significantly to improving the functioning of the patient.

Author Information

Bornemann R, Pflugmacher R, Webler M, Koch EM, Wirtz DC, Frey SP - Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn.

Dengler J - Klinik für Neurochirurgie, Charité Universitätsmedizin Berlin.

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