A Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Feasibility Study to Evaluate the TURRIS Facet Fusion System as an Adjuvant to Unilateral Pedicle Screw Fixation in Lumbar Spinal Surgery

Conditions
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Spinal Disease

Intervention / Treatment
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* Device: Turris Facet Fuser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: one-level fusion at L4/L5 with dorsal instrumentation and, if required, with monolateral decompression and/or intervertebral disc removal and implantation of an intervertebral implant Exclusion Criteria: Patient had previous surgical stabilizations at the involved or adjacent levels has lytic spondylolisthesis has degenerative spondylolisthesis grade II or higher has radiographic signs of significant instability and/or hypermobility of the segment (>3mm translation, >11° rotation difference from adjacent level) has scoliosis > 10° at the involved segment has osteoporosis to a degree that spinal instrumentation would be contraindicated. has presence of active malignancy. has overt or active infection, either local or systemic is less than 18 years old is pregnant or plan a pregnancy during the study duration has a BMI > 35 has a progressive neuromuscular disease has a condition which requires postoperative medications that may interfere with bone metabolism has a history of autoimmune disease has a history of endocrine or metabolic disorders known to affect osteogenesis is mentally ill or incompetent is an alcohol and/or drug abuser is not available for follow up visits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Turris Facet Fuser<br> | Device: Turris Facet Fuser<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion of the L4/L5 Segment |  | within 12 months | 
| Change from Baseline in Spine Tango Oswestry score |  | Baseline, 3 months, 6 months and 12 months | 
| Change from Baseline in Spine Tango COMI score |  | Baseline, 3 months, 6 months and 12 months | 
| Change from Baseline in Spine Tango VAS score for back- and leg-pain |  | 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 | intra-operative |