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

SpineWelding

Status

Terminated

Conditions

Spinal Disease

Treatments

Device: Turris Facet Fuser

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02294669

Turris

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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