Spinal Disease
Conditions
Brief summary
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
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.
Interventions
DEVICETurris Facet Fuser
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.
Sponsors
ISS integrated Scientific Services AG
SpineWelding AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number, severity and causality of intra-operative and post-operative complications | 1 year | Patients will be observed during hospitalization, at 6 weeks, 3 months, 6 months and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | intra-operative | Radiation exposure time during the insertion process of the pedicle screw system and the Turris Facet Fusion will be recorded separately |
Countries
Switzerland
Outcome results
None listed