This is a prospective, exploratory study to verify intra-operative handling and safety and to collect preliminary short-term safety and efficacy data of the Turris® Facet Fuser, a small bioresorbable device for the immediate immobilization of the facet joint. Patients eligible for study enrollment will present with degenerative lumbar spinal diseases involving the L4/L5 segment and requiring spinal fusion.
The Turris® Facet Fuser is an investigational resorbable device intended to support spinal segment fusion in individuals suffering from degenerative lumbar spinal diseases. The device is directly inserted in the facet joint of the affected segment using the BoneWelding® technology, a soft tissue sparing, ultrasound based insertion method which confers immediate stability to the implant. Aim of this prospective, exploratory study is to verify intra-operative handling and safety of the Turris® Facet Fusion System and to collect preliminary short-term safety and efficacy data on this innovative implant by observing the healing process over a period of one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Study participants will have a Turris Facet Fuser inserted into the contralateral facet joint, instead of a state of the art contralateral pedicle screw system.
Neuro- und Wirbelsäulenzentrum
Cham, CH, Switzerland
Rückenzentrum Oberaargau AG
Langenthal, Switzerland
The number, severity and causality of intra-operative and post-operative complications
Patients will be observed during hospitalization, at 6 weeks, 3 months, 6 months and 12 months
Time frame: 1 year
Fusion of the L4/L5 Segment
Time frame: within 12 months
Change from Baseline in Spine Tango Oswestry score
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Spine Tango COMI score
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Spine Tango VAS score for back- and leg-pain
Time frame: Baseline, 3 months, 6 months and 12 months
Intraoperative radiation exposure
Radiation exposure time during the insertion process of the pedicle screw system and the Turris Facet Fusion will be recorded separately
Time frame: intra-operative
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