Status:
TERMINATED
A Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery
Lead Sponsor:
SpineWelding AG
Collaborating Sponsors:
ISS integrated Scientific Services AG
Conditions:
Spinal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 inse...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02294669
Start Date
February 1 2015
End Date
June 18 2016
Last Update
April 4 2022
Active Locations (2)
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1
Neuro- und Wirbelsäulenzentrum
Cham, CH, Switzerland, 6330
2
Rückenzentrum Oberaargau AG
Langenthal, Switzerland, 4900