Clinical trial NCT02294669: A Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery
Official title: A Feasibility Study to Evaluate the TURRIS Facet Fusion System as an Adjuvant to Unilateral Pedicle Screw Fixation in Lumbar Spinal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Disease
Lead sponsor: SpineWelding AG
Sponsor class: INDUSTRY
Collaborators: name: ISS integrated Scientific Services AG
First posted: 2014-11-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The number, severity and causality of intra-operative and post-operative complications
timeFrame: 1 year
Secondary outcomes:
measure: Fusion of the L4/L5 Segment
timeFrame: within 12 months
measure: Change from Baseline in Spine Tango Oswestry score
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Change from Baseline in Spine Tango COMI score
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Change from Baseline in Spine Tango VAS score for back- and leg-pain
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Intraoperative radiation exposure
timeFrame: intra-operative
Other outcomes:
Locations:
city: Cham
country: Switzerland
facility: Neuro- und Wirbelsäulenzentrum
state: CH
city: Langenthal
country: Switzerland
facility: Rückenzentrum Oberaargau AG
Study officials:
affiliation: Rückenzentrum Oberaargau
name: Ulrich Berlemann, MD
role: PRINCIPAL_INVESTIGATOR
References: