A Feasibility Study to Evaluate the TURRIS Facet Fusion S... | NCT02294669

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

NCT02294669

Sponsor

SpineWelding AG

Status

Terminated

Last Update Posted

Apr 4, 2022Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Spinal Disease

Interventions

Turris Facet Fuser

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Strategic reasons

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Jun 18, 2016Actual

Completion Date

Jun 18, 2016Actual

First Submitted Date

Nov 3, 2014

First Submission Date that Met QC Criteria

Nov 14, 2014

First Posted Date

Nov 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2022

Last Update Posted Date

Apr 4, 2022Actual

Name	Class
ISS integrated Scientific Services AG	UNKNOWN

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Turris Facet Fuser	Experimental		Device: Turris Facet Fuser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Neuro- und Wirbelsäulenzentrum		Cham	CH	6330	Switzerland
Rückenzentrum Oberaargau AG

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases