Spinal DiseaseNCT02294669
A Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery
A study testing Turris Facet Fuser in people with Spinal Disease, run by SpineWelding AG at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Disease
- What is being tested?
- Turris Facet Fuser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Feb 2015to 18 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Neuro- und Wirbelsäulenzentrum
Cham, CH, 6330
Rückenzentrum Oberaargau AG
Langenthal, 4900
About this study
Official title: A Feasibility Study to Evaluate the TURRIS Facet Fusion System as an Adjuvant to Unilateral Pedicle Screw Fixation in Lumbar Spinal Surgery
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.
Read the 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.
- Conditions
- Spinal Disease
- Being tested
- Turris Facet Fuser
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turris Facet FuserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Turris Facet Fuser | Experimental | Not described Receives: Device: Turris Facet Fuser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (5)
Fusion of the L4/L5 Segment
Measured: within 12 months
Change from Baseline in Spine Tango Oswestry score
Measured: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Spine Tango COMI score
Measured: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Spine Tango VAS score for back- and leg-pain
Measured: Baseline, 3 months, 6 months and 12 months
Intraoperative radiation exposure
Radiation exposure time during the insertion process of the pedicle screw system and the Turris Facet Fusion will be recorded separately
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completion18 Jun 2016
- Study completion18 Jun 2016
Why it stopped: Strategic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpineWelding AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ISS integrated Scientific Services AG
- Responsible party
- Sponsor
- Investigators
- Ulrich Berlemann, MD, Principal investigator, Rückenzentrum Oberaargau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294669
- Sponsor's protocol ID
- Turris
- Status last verified
- Mar 2022
- First submitted
- 3 Nov 2014
- Last updated
- 4 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the TURRIS Facet Fusion System as an Adjuvant to Unilateral Pedicle Screw Fixation in Lumbar Spinal Surgery
- ClinicalTrials.gov ID
- NCT02294669
- Acronym / sponsor ID
- Turris
- Conditions
- Spinal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic reasons
- Enrolment
- 3 participants (actual)
- Lead sponsor
- SpineWelding AGIndustry (pharma, biotech, devices)
- Collaborators
- ISS integrated Scientific Services AG
- Study start
- Feb 2015 (actual)
- Primary completion
- 18 Jun 2016 (actual)
- Study completion
- 18 Jun 2016 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Turris Facet Fuser | Experimental | Device: Turris Facet Fuser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turris Facet FuserStudy participants will have a Turris Facet Fuser inserted into the contralateral facet joint, instead of a state of the art contralateral pedicle screw system. | Device | Turris Facet Fuser |
Primary outcome
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
5 secondary outcomes
Fusion of the L4/L5 Segment
Time frame: within 12 months
Change from Baseline in Spine Tango Oswestry score
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Spine Tango COMI score
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Spine Tango VAS score for back- and leg-pain
Time frame: Baseline, 3 months, 6 months and 12 months
Intraoperative radiation exposure
Time frame: intra-operative
Results and safety
The study was stopped early (reason given: Strategic reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Berlemann, MD principal investigator
Rückenzentrum Oberaargau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turris Facet Fuser in people with Spinal Disease, run by SpineWelding AG at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Strategic reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number, severity and causality of intra-operative and post-operative complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.