Back to resultsA Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery
Primary Purpose
Spinal Disease
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Turris Facet Fuser
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Disease
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
Sites / Locations
- Neuro- und Wirbelsäulenzentrum
- Rückenzentrum Oberaargau AG
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Turris Facet Fuser
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Fusion of the L4/L5 Segment
Change from Baseline in Spine Tango Oswestry score
Change from Baseline in Spine Tango COMI score
Change from Baseline in Spine Tango VAS score for back- and leg-pain
Intraoperative radiation exposure
Radiation exposure time during the insertion process of the pedicle screw system and the Turris Facet Fusion will be recorded separately
Full Information
NCT ID
NCT02294669
First Posted
November 3, 2014
Last Updated
March 22, 2022
Sponsor
SpineWelding AG
Collaborators
ISS integrated Scientific Services AG
1. Study Identification
Unique Protocol Identification Number
NCT02294669
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Strategic reasons
Study Start Date
February 2015 (Actual)
Primary Completion Date
June 18, 2016 (Actual)
Study Completion Date
June 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SpineWelding AG
Collaborators
ISS integrated Scientific Services AG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Turris Facet Fuser
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Turris Facet Fuser
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number, severity and causality of intra-operative and post-operative complications
Description
Patients will be observed during hospitalization, at 6 weeks, 3 months, 6 months and 12 months
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Fusion of the L4/L5 Segment
Time Frame
within 12 months
Title
Change from Baseline in Spine Tango Oswestry score
Time Frame
Baseline, 3 months, 6 months and 12 months
Title
Change from Baseline in Spine Tango COMI score
Time Frame
Baseline, 3 months, 6 months and 12 months
Title
Change from Baseline in Spine Tango VAS score for back- and leg-pain
Time Frame
Baseline, 3 months, 6 months and 12 months
Title
Intraoperative radiation exposure
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Berlemann, MD
Organizational Affiliation
Rückenzentrum Oberaargau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuro- und Wirbelsäulenzentrum
City
Cham
State/Province
CH
ZIP/Postal Code
6330
Country
Switzerland
Facility Name
Rückenzentrum Oberaargau AG
City
Langenthal
ZIP/Postal Code
4900
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery
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