A Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery
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|ClinicalTrials.gov Identifier: NCT02294669|
Recruitment Status : Recruiting
First Posted : November 19, 2014
Last Update Posted : May 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Disease||Device: Turris Facet Fuser||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
|Experimental: Turris Facet Fuser||
Device: Turris 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.
- The number, severity and causality of intra-operative and post-operative complications [ Time Frame: 1 year ]Patients will be observed during hospitalization, at 6 weeks, 3 months, 6 months and 12 months
- Fusion of the L4/L5 Segment [ Time Frame: within 12 months ]
- Change from Baseline in Spine Tango Oswestry score [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
- Change from Baseline in Spine Tango COMI score [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
- Change from Baseline in Spine Tango VAS score for back- and leg-pain [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
- Intraoperative radiation exposure [ Time Frame: intra-operative ]Radiation exposure time during the insertion process of the pedicle screw system and the Turris Facet Fusion will be recorded separately
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294669
|Contact: Barbara Froesch, Ph.D.||+41 44 204 61 25|
|Contact: Joerg Mayer, Ph.D.||+41 44 204 61 28|
|Thun, Switzerland, 3600|
|Contact: Tanja Thönen +41 33 225 55 22|
|Principal Investigator: Ulrich Berlemann, MD|
|Principal Investigator:||Ulrich Berlemann, MD||Dasrückenzentrum|