A Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery

A Feasibility Study to Evaluate the TURRIS Facet Fusion System as an Adjuvant to Unilateral Pedicle Screw Fixation in Lumbar Spinal Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Disease
• Intervention / Treatment: Device: Turris Facet Fuser

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Langenthal, Switzerland, 4900
    • Rückenzentrum Oberaargau AG
  • CH
    • Cham, CH, Switzerland, 6330
      • Neuro- und Wirbelsäulenzentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Radiation exposure time during the insertion process of the pedicle screw system and the Turris Facet Fusion will be recorded separately	intra-operative

Collaborators and Investigators

• Sponsor: SpineWelding AG
• Collaborators: ISS integrated Scientific Services AG
• Investigators: Principal Investigator: Ulrich Berlemann, MD, Rückenzentrum Oberaargau

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): June 18, 2016
• Study Completion (Actual): June 18, 2016

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: Turris