SpineJack® Versus Conservative Treatment Study (SPICO Study)
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
1 other identifier
interventional
100
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2016
CompletedStudy Start
First participant enrolled
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2020
CompletedApril 20, 2023
April 1, 2023
3.4 years
January 5, 2016
April 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
VAS
Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up
1 and 12 months follow-up
Secondary Outcomes (6)
Oswestry Disability Index
Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
EQ-5D
Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Kyphotic angle
Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Regional Kyphotic Angle
Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Evaluation of safety through evaluation of adverse events
Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
- +1 more secondary outcomes
Study Arms (2)
SpineJack® system
EXPERIMENTALSpine fracture management
Conservative management
ACTIVE COMPARATORSurgical corset according to measurement's impression, rigid corset with sternal support
Interventions
Spine fracture management for traumatic vertebral compression fracture
Surgical corset according to measurement's impression, rigid corset with sternal support
Eligibility Criteria
You may qualify if:
- Patient must have signed the consent form
- Male or Female between 18 and 60 years old
- 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
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Hopital Jean Minjoz Besancon
Besançon, France
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, France
CHU Brest
Brest, France
Centre Hospitalier De Chambéry
Chambéry, France
CHU de Dijon
Dijon, France
APHM, Hopital Nord Marseille
Marseille, France
CHU de Rennes
Rennes, France
CHU de Rouen-Hopital Charles Nicolle
Rouen, France
Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, France
Related Publications (1)
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.
PMID: 38427996DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marc Vital, Prof.
Hopital Pellegrin - Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2016
First Posted
January 15, 2016
Study Start
January 13, 2016
Primary Completion
May 27, 2019
Study Completion
May 25, 2020
Last Updated
April 20, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share