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

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ClinicalTrials.gov Identifier: NCT02294669
Recruitment Status : Recruiting
First Posted : November 19, 2014
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
ISS integrated Scientific Services AG
Information provided by (Responsible Party):
SpineWelding AG

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.


Condition or disease Intervention/treatment Phase
Spinal Disease Device: Turris Facet Fuser Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate the TURRIS Facet Fusion System as an Adjuvant to Unilateral Pedicle Screw Fixation in Lumbar Spinal Surgery
Study Start Date : February 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The number, severity and causality of intra-operative and post-operative complications [ Time Frame: 1 year ]
    Patients will be observed during hospitalization, at 6 weeks, 3 months, 6 months and 12 months


Secondary Outcome Measures :
  1. Fusion of the L4/L5 Segment [ Time Frame: within 12 months ]
  2. Change from Baseline in Spine Tango Oswestry score [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
  3. Change from Baseline in Spine Tango COMI score [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
  4. Change from Baseline in Spine Tango VAS score for back- and leg-pain [ Time Frame: Baseline, 3 months, 6 months and 12 months ]
  5. Intraoperative radiation exposure [ Time Frame: intra-operative ]
    Radiation exposure time during the insertion process of the pedicle screw system and the Turris Facet Fusion will be recorded separately



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294669


Contacts
Contact: Barbara Froesch, Ph.D. +41 44 204 61 25
Contact: Joerg Mayer, Ph.D. +41 44 204 61 28

Locations
Switzerland
Dasrückenzentrum Recruiting
Thun, Switzerland, 3600
Contact: Tanja Thönen    +41 33 225 55 22      
Principal Investigator: Ulrich Berlemann, MD         
Sponsors and Collaborators
SpineWelding AG
ISS integrated Scientific Services AG
Investigators
Principal Investigator: Ulrich Berlemann, MD Dasrückenzentrum

Responsible Party: SpineWelding AG
ClinicalTrials.gov Identifier: NCT02294669     History of Changes
Other Study ID Numbers: Turris
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases