Spinal FracturesSAKOSNCT02461810
Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques
A study testing Vertebral fracture surgery SpineJack® and Balloon Kyphoplasty in people with Spinal Fractures and Vertebral Compression Fractures, run by Vexim SA at 13 sites in 5 countries.
Trial summary
The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Spinal Fractures, Vertebral Compression Fractures, Back Injuries
- What is being tested?
- Vertebral fracture surgery SpineJack® and Balloon Kyphoplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Apr 2015to 20 Feb 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female with at least 50 years of age
- 1 painful VCF which at least meet all following criteria:
- Fracture due to diagnosed or presumed underlying osteoporosis
- VCF between T7 and L3
- Fracture age <3 months
- VCF shows loss of height in the anterior, mid or posterior third of the VB from estimated pre-fracture configuration of at least 15% but not more than 40% based on X-Ray at baseline
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- The Index fracture is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI (or bone scan if patient is contraindicated for MRI)
- Patient has failed conservative medical therapy, defined as either having a VAS back pain score of ≥50 mm at 6 weeks after initiation of fracture care or a VAS back pain score of ≥70mm at 2 weeks after initiation of fracture care
- Investigator believes target VB is suitable for SpineJack procedure and Balloon kyphoplasty (e.g., appropriate pedicle diameter) assessed on CT scan pre op
- Patient has an Oswestry Disability Index (ODI) score of ≥ 30/100
- Patient is mentally capable and willing to sign a study specific informed consent as documentation of the informed consent process prior to any study procedures
- The patient is willing and able to comply with all study requirements including follow-up visits and radiographic assessments.
Who cannot join
- Target VCF due to underlying or suspected tumor
- Target VCF due to high-energy trauma
- Target VCF is diagnosed as an osteonecrotic fracture
- Segmental kyphosis of target VB of >30°
- Any prior surgical treatment for a vertebral body compression fracture or other surgical procedure on target VB or adjacent level
- The patient has uncontrolled diabetes
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- Pre-existing or clinically unstable neurologic deficit
- The patient has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated
- Any physical exam evidence of myelopathy or radiculopathy
- The patient has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
- Patient not able to walk without assistance prior to fracture
- Any radiographic evidence of pedicle fracture visible on CT scan pre op
- Spondylolisthesis >Grade 1 at target VB
- Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.)
- A medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy and/or taking warfarin (Coumadin) or other anticoagulant on regular basis for coagulopathy (with a threshold for normal being INR≤1.5, PTT within lab normal range, and platelet count > 100,000)
- Pain due to any other condition that requires daily narcotic medication
- Disabling back pain due to causes other than acute fracture
- History of intolerance or allergic reaction to titanium or acrylic compounds
- Active systemic or local infection at baseline
- Body mass index >40
- Severe cardiopulmonary deficiencies
- Any other medical illness or condition that, in the investigator's opinion, is likely to impair long-term follow-up (e.g., cancer) or greatly increase the risk of surgery including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
- Any evidence of alcohol or drug abuse
- The patient has uncontrolled psychiatric illness or severe dementia
- The patient is currently on anti-cancer therapy or anti-HIV therapy
- Patient's life expectancy is less than the study duration or undergoing palliative care
- Participating in any other investigational study
- The patient is on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
- The patient is known to be involved in medical litigation including Workmen's Compensation
- Patient with contraindication for MRI
- The patient is pregnant or considering getting pregnant during study participation.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
France5 sites
Hôpital Jean Minjoz Service Neurochirurgie
Besançon
Centre Hospitalier La Cavale Blanche
Brest
CHU La Timone
Marseille
Hôpital Nord
Marseille
CHU Hôtel Dieu Service Neuro traumatologie
Nantes
Germany3 sites
Klinik und Poliklinik fur Orthopädie Universitatsklinikum
Bonn
Loretto-Krankenhaus Freiburg
Freiburg im Breisgau
Krankenhaus NEUWERK Sankt Augustinus kliniken
Mönchengladbach
Spain2 sites
Hospital Universitario Marques de Valdecilla
Santander
Hospital Clinico Universitario de Valladolid,
Valladolid
Switzerland2 sites
HFR Fribourg - Hôpital cantonal
Fribourg
Clinique Bois-Cerf
Lausanne
About this study
Official title: A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp
The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.
- Being tested
- Vertebral fracture surgery SpineJack®, Balloon Kyphoplasty
- Medical subject headings
- Spinal Fractures, Back Injuries, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertebral fracture surgery SpineJack®Device
Vertebral augmentation for one osteoporotic vertebral compression fracture
Balloon KyphoplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SpineJack® system | Experimental | VCF treatment system Vertebral fracture surgery Receives: Device: Vertebral fracture surgery SpineJack® |
| Balloon Kyphoplasty | Active comparator | VCF treatment system Vertebral fracture surgery Receives: Procedure: Balloon Kyphoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Study Success
The primary composite endpoint defines a successful subject if the following components are satisfied (safety and effectiveness):
- Reduction in VCF fracture-related pain at 12 months from baseline as measured by a 100 mm VAS scale (reduction of pain at 12 months by > 20 mm) AND,
- Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) AND,
- Absence of device-related serious adverse events, defined as device-related adverse events (device migration, recollapse, protrusion) or symptomatic cement extravasation requiring surgical re-intervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation.
Measured: 12 month post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startApr 2015
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vexim SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ACES Ing.-GmbH
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre HONTAS, Director Clinical Affairs, Study director, Vexim SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461810
- Sponsor's protocol ID
- SAKOS - EU2014-05
- Acronym
- SAKOS
- Status last verified
- Feb 2019
- First submitted
- 27 May 2015
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp
- ClinicalTrials.gov ID
- NCT02461810
- Acronym / sponsor ID
- SAKOS / SAKOS - EU2014-05
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Vexim SAIndustry (pharma, biotech, devices)
- Collaborators
- ACES Ing.-GmbH
- Study start
- Apr 2015
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 3 Jun 2015 (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.
The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SpineJack® system | Experimental | Device: Vertebral fracture surgery SpineJack®VCF treatment system Vertebral fracture surgery |
| Balloon Kyphoplasty | Active comparator | Procedure: Balloon KyphoplastyVCF treatment system Vertebral fracture surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or Female with at least 50 years of age
- 1 painful VCF which at least meet all following criteria:
- Patient has failed conservative medical therapy, defined as either having a VAS back pain score of ≥50 mm at 6 weeks after initiation of fracture care or a VAS back pain score of ≥70mm at 2 weeks after initiation of fracture care
- Investigator believes target VB is suitable for SpineJack procedure and Balloon kyphoplasty (e.g., appropriate pedicle diameter) assessed on CT scan pre op
- Patient has an Oswestry Disability Index (ODI) score of ≥ 30/100
Key exclusion criteria (31 listed)
- Target VCF due to underlying or suspected tumor
- Target VCF due to high-energy trauma
- Target VCF is diagnosed as an osteonecrotic fracture
- Segmental kyphosis of target VB of >30°
- Any prior surgical treatment for a vertebral body compression fracture or other surgical procedure on target VB or 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 |
|---|---|---|
| Vertebral fracture surgery SpineJack®Vertebral augmentation for one osteoporotic vertebral compression fracture | Device | SpineJack® system |
| Balloon Kyphoplasty | Procedure or surgery | Balloon Kyphoplasty |
Primary outcome
Proportion of Participants With Study Success
Time frame: 12 month post-op
The primary composite endpoint defines a successful subject if the following components are satisfied (safety and effectiveness): 1. Reduction in VCF fracture-related pain at 12 months from baseline as measured by a 100 mm VAS scale (reduction of pain at 12 months by > 20 mm) AND, 2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) AND, 3. Absence of device-related serious adverse events, defined as device-related adverse events (device migration, recollapse, protrusion) or symptomatic cement extravasation requiring surgical re-intervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Fractures
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Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
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Controlled Reduction of AO Spine B3 Fractures in Ankylosing Spinal Disorders Using an Inflatable Positioning Device: Technical Note and Retrospective Single-centre Case Series
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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.
Marie-Pierre HONTAS, Director Clinical Affairs study director
Vexim SA
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertebral fracture surgery SpineJack® and Balloon Kyphoplasty in people with Spinal Fractures and Vertebral Compression Fractures, run by Vexim SA at 13 sites in 5 countries.
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 12 inclusion and 31 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: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Germany, Spain, Switzerland, Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of Participants With Study Success (time frame: 12 month post-op). 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 22 Feb 2019.