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

NCT02294669 | Terminated

• 1 other identifier: Turris
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  intra-operative

Study Arms (1)

Turris Facet Fuser

EXPERIMENTAL

Device: Turris Facet Fuser

Interventions

Turris Facet Fuser 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.

Turris Facet Fuser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SpineWelding AG: lead
• ISS integrated Scientific Services AG: collaborator

Study Sites (2)

Neuro- und Wirbelsäulenzentrum

Cham, CH, 6330, Switzerland

Location

Rückenzentrum Oberaargau AG

Langenthal, 4900, Switzerland

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ulrich Berlemann, MD

  Rückenzentrum Oberaargau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 19, 2014
• Study Start: February 1, 2015
• Primary Completion: June 18, 2016
• Study Completion: June 18, 2016
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CH (2)