Clinical Data

8-18 month Follow-up (Gaetani - J Neurosurg Sci 2013)

Percutaneous Arthrodesis of Sacro-iliac Joint: A Pilot Study.

Gaetani P, Miotti D, Risso A, Bettaglio R, Bongetta D, Custodi V, Silvani V.
J Neurosurg Sci. 2013;57:297–301.

ABSTRACT

Aim. Between 15-30% of patients presenting with low back pain have some SI joint involvement. The diagnosis of SI joint involvement in low back pain is quite difficult and depends on a detailed combination of clinical manoeuvres and injection tests. In 5% of patients with SI joint pain, the joint is physically unstable (termed disruption) resulting in ineffective medical and conservative therapeutic options. In this study we present the results of the first 12 cases of SI joint disruption treated using a minimally invasive SI joint arthrodesis system in order to evaluate the safety and the efficacy of this system.

Methods. Medical charts at a single center were reviewed for demographics, perioperative metrics, patient reported outcomes for pain, function and quality of life (NRS, ODI and RDQ respectively), as well as satisfaction with surgery (yes/no) and results of postoperative CT scan.

Results. Mean age was 53 years (range 36-71) and all patients were female. Patient reported outcomes at follow up (range 8-18 months) improved clinically as well as statistically as evidenced by a mean improvement in pain on NRS of 4 points, back related function on ODI by 19.4 points, and in quality of life measured using RDQ of 13.6 points (all P=0.01). Local hematoma requiring drainage was apparent in 2 patients. Patient satisfaction was 100%. All 3 month CT scans showed initial fusion.

Conclusion. The results of this study confirm that MIS SI joint fusion using the iFuse Implant System is safe and effective method of treating patients with SI joint disruption.

Conflicts of interest. Authors declare, under their responsibility, that they have no commercial association that might create a conflict of interest in connection with the submitted manuscript.

Conflicts of interest.

Authors declare, under their responsibility, that they have no commercial association that might create a conflict of interest in connection with the submitted manuscript.

Gaetani - conducts clinical research for SI-BONE, Inc.

3,600+Treating Surgeons

95,000+iFuse Procedures Performed

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