Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Trauma
Conditions
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.
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.
Interventions
DEVICESpineJack system
Spine fracture management for traumatic vertebral compression fracture
DEVICEConservative management
Surgical corset according to measurement's impression, rigid corset with sternal support
Sponsors
Statitec
Vexim SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patient must have signed the consent form 2. Male or Female between 18 and 60 years old 3. 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). 4. Vertebral kyphosis angle \>10° 5. Patient is eligible to treatment with brace 6. Technical feasibility of a SpineJack® procedure and brace 1 to 5 days after screening/baseline
Exclusion criteria
1. Vertebral fracture more than 10 days old 2. Spontaneous osteoporotic vertebral fracture 3. Neurological signs or symptoms related to the vertebral fracture 4. Vertebral kyphosis angle \>30° 5. Active systemic or local infection at baseline 6. Patient with substance abuse 7. History of intolerance or allergic reaction to titanium or acrylic compounds 8. Fracture geometry making the insertion of the implant impossible 9. Malignant lesions 10. 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\* 11. Patient on long-term steroid therapy (steroid dose ≥ 30 mg /day for \> 3 months) 12. Patient presenting with a non-correctable spontaneous or therapeutic coagulation disorder. 13. Non-compliant patient: Impossibility to participate in the study and to be followed-up for 2 years. 14. Participating in any other investigational study 15. Female patients who are pregnant, breastfeeding, or planning to get pregnant during the course of the study 16. Patient not affiliated to social security \*: including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS | 1 and 12 months follow-up | Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Costs comparison of overall treatments | Screening/baseline, immediat post-op, 1, 3, 12 and 24 months |
Countries
France
Outcome results
None listed