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

NCT ID: NCT02294669

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-06-18

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.

Conditions

Spinal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Turris Facet Fuser

Group Type: EXPERIMENTAL

Turris Facet Fuser

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ISS integrated Scientific Services AG

UNKNOWN

Sponsor Role: collaborator

SpineWelding AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrich Berlemann, MD

Role: PRINCIPAL_INVESTIGATOR

Rückenzentrum Oberaargau

Locations

Neuro- und Wirbelsäulenzentrum

Cham, CH, Switzerland

Rückenzentrum Oberaargau AG

Langenthal, , Switzerland

Countries

Switzerland

Other Identifiers

Turris

Identifier Type: -

Identifier Source: org_study_id