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

Spinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02294669
• Other study ID #: Turris
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 18, 2016

Study information

• Verified date: March 2022
• Source: SpineWelding AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 18, 2016
• Est. primary completion date: June 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Disease
• Spinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Neuro- und Wirbelsäulenzentrum	Cham	CH
Switzerland	Rückenzentrum Oberaargau AG	Langenthal

Sponsors (2)

Lead Sponsor	Collaborator
SpineWelding AG	ISS integrated Scientific Services AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fusion of the L4/L5 Segment		within 12 months
Secondary	Change from Baseline in Spine Tango Oswestry score		Baseline, 3 months, 6 months and 12 months
Secondary	Change from Baseline in Spine Tango COMI score		Baseline, 3 months, 6 months and 12 months
Secondary	Change from Baseline in Spine Tango VAS score for back- and leg-pain		Baseline, 3 months, 6 months and 12 months
Secondary	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