Spinal FracturesNCT02657265
SpineJack® Versus Conservative Treatment Study (SPICO Study)
A study testing SpineJack system and Conservative management in people with Spinal Fractures and Vertebral Compression Fractures, run by Vexim SA at 9 sites in France.
Trial summary
This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows: 1. SpineJack® system 2. Conservative Orthopedic Management consisting of brace and pain medication. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Fractures, Vertebral Compression Fractures, Back Injuries
- What is being tested?
- SpineJack system and Conservative management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesFrance
- Study dates
- 13 Jan 2016to 25 May 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient must have signed the consent form
- Male or Female between 18 and 60 years old
- One to two painful traumatic fractures, non-pathological, traumatic vertebral fracture is less than 10 days, between T11 and L5, type A1 and A3.1 according to Magerl classification. All the fractures should meet the inclusion criteria (deformity, etiology, technical possibility of performing the procedure).
- Vertebral kyphosis angle >10°
- Patient is eligible to treatment with brace
- Technical feasibility of a SpineJack® procedure and brace 1 to 5 days after screening/baseline
Who cannot join
- Vertebral fracture more than 10 days old
- Spontaneous osteoporotic vertebral fracture
- Neurological signs or symptoms related to the vertebral fracture
- Vertebral kyphosis angle >30°
- Active systemic or local infection at baseline
- Patient with substance abuse
Show all 16Show fewer
- History of intolerance or allergic reaction to titanium or acrylic compounds
- Fracture geometry making the insertion of the implant impossible
- Malignant lesions
- 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*
- Patient on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
- Patient presenting with a non-correctable spontaneous or therapeutic coagulation disorder.
- Non-compliant patient: Impossibility to participate in the study and to be followed-up for 2 years.
- Participating in any other investigational study
- Female patients who are pregnant, breastfeeding, or planning to get pregnant during the course of the study
- Patient not affiliated to social security *: including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hopital Jean Minjoz Besancon
Besançon
CHU de Bordeaux - Hopital Pellegrin
Bordeaux
CHU Brest
Brest
Centre Hospitalier De Chambéry
Chambéry
CHU de Dijon
Dijon
APHM, Hopital Nord Marseille
Marseille
CHU de Rennes
Rennes
CHU de Rouen-Hopital Charles Nicolle
Rouen
Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire
About this study
Official title: Prospective Multicenter Randomized Study Comparing Two Standard Treatments: SpineJack® System and Conservative Orthopedic Management in Acute Traumatic Vertebral Fractures Types A1 and A3.1 According to the Magerl Classification
This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:
- SpineJack® system
- Conservative Orthopedic Management consisting of brace and pain medication.
Read the detailed description
100 subjects (18 to 60 years old) will be enrolled (1:1) with one to two painful traumatic fractures, non-pathological (types A1 and A3.1 by Magerl Classification).
Subjects will be followed at admission, procedure, discharge, 1 month, 3 months, 12 months and 24 months post Vertebral Compression Fracture (VCF) reduction procedure or the set-up of the brace.
The estimated enrollment period is 12 months and each patient should perform a 24 months follow-up period. Therefore, the total study duration is estimated to be 36 months for the complete study.
- Being tested
- SpineJack system, Conservative management
- Medical subject headings
- Spinal Fractures, Back Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpineJack systemDevice
Spine fracture management for traumatic vertebral compression fracture
Conservative managementDevice
Surgical corset according to measurement's impression, rigid corset with sternal support
| Study group | Role | What they receive |
|---|---|---|
| SpineJack® system | Experimental | Spine fracture management Receives: Device: SpineJack system |
| Conservative management | Active comparator | Surgical corset according to measurement's impression, rigid corset with sternal support Receives: Device: Conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up
Measured: 1 and 12 months follow-up
Secondary outcomes (6)
Oswestry Disability Index
Measured: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
EQ-5D
Measured: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Kyphotic angle
Measured: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Regional Kyphotic Angle
Measured: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Evaluation of safety through evaluation of adverse events
Measured: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Costs comparison of overall treatments
Measured: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start13 Jan 2016
- Primary completion27 May 2019
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vexim SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statitec
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Vital, Prof., Principal investigator, Hopital Pellegrin - Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657265
- Sponsor's protocol ID
- EU2014-09
- Status last verified
- Apr 2023
- First submitted
- 5 Jan 2016
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ould-Slimane M, Petit A, Gille O, Kaya JM, Touta A, Lebhar J, Grelat M. A prospective multicenter randomized study comparing the SpineJack system and nonsurgical management with a brace in acute traumatic vertebral fractures: the SPICO study. J Neurosurg Spine. 2024 Mar 1;40(6):790-800. doi: 10.3171/2023.12.SPINE23824. Print 2024 Jun 1.
PubMed 38427996
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Randomized Study Comparing Two Standard Treatments: SpineJack® System and Conservative Orthopedic Management in Acute Traumatic Vertebral Fractures Types A1 and A3.1 According to the Magerl Classification
- ClinicalTrials.gov ID
- NCT02657265
- Acronym / sponsor ID
- EU2014-09
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vexim SAIndustry (pharma, biotech, devices)
- Collaborators
- Statitec
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 15 Jan 2016 (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 study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:
- SpineJack® system
- Conservative Orthopedic Management consisting of brace and pain medication.
Detailed description
100 subjects (18 to 60 years old) will be enrolled (1:1) with one to two painful traumatic fractures, non-pathological (types A1 and A3.1 by Magerl Classification).
Subjects will be followed at admission, procedure, discharge, 1 month, 3 months, 12 months and 24 months post Vertebral Compression Fracture (VCF) reduction procedure or the set-up of the brace.
The estimated enrollment period is 12 months and each patient should perform a 24 months follow-up period. Therefore, the total study duration is estimated to be 36 months for the complete study.
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: SpineJack systemSpine fracture management |
| Conservative management | Active comparator | Device: Conservative managementSurgical corset according to measurement's impression, rigid corset with sternal support |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient must have signed the consent form
- Male or Female between 18 and 60 years old
- One to two painful traumatic fractures, non-pathological, traumatic vertebral fracture is less than 10 days, between T11 and L5, type A1 and A3.1 according to Magerl classification. All the fractures should meet the inclusion criteria (deformity, etiology, technical possibility of performing the procedure).
- Vertebral kyphosis angle >10°
- Patient is eligible to treatment with brace
Key exclusion criteria (16 listed)
- Vertebral fracture more than 10 days old
- Spontaneous osteoporotic vertebral fracture
- Neurological signs or symptoms related to the vertebral fracture
- Vertebral kyphosis angle >30°
- Active systemic or local infection at baseline
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 |
|---|---|---|
| SpineJack systemSpine fracture management for traumatic vertebral compression fracture | Device | SpineJack® system |
| Conservative managementSurgical corset according to measurement's impression, rigid corset with sternal support | Device | Conservative management |
Primary outcome
VAS
Time frame: 1 and 12 months follow-up
Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up
6 secondary outcomes
Oswestry Disability Index
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
EQ-5D
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Kyphotic angle
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Regional Kyphotic Angle
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Evaluation of safety through evaluation of adverse events
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Costs comparison of overall treatments
Time frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
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 20 Apr 2023.
- Derived from this study: PubMed 38427996Ould-Slimane M, Petit A, Gille O, Kaya JM, Touta A, Lebhar J, Grelat M. A prospective multicenter randomized study comparing the SpineJack system and nonsurgical management with a brace in acute traumatic vertebral fractures: the SPICO study. J Neurosurg Spine. 2024 Mar 1;40(6):790-800. doi: 10.3171/2023.12.SPINE23824. Print 2024 Jun 1.
- Individual participant dataSharing planned: No
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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.
Jean-Marc Vital, Prof. principal investigator
Hopital Pellegrin - Bordeaux
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpineJack system and Conservative management in people with Spinal Fractures and Vertebral Compression Fractures, run by Vexim SA at 9 sites in France.
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 6 inclusion and 16 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 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
VAS (time frame: 1 and 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657265, which also lists 1 linked publication.
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 20 Apr 2023.