Trauma Clinical Trial
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
NCT number | NCT02657265 |
Other study ID # | EU2014-09 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 13, 2016 |
Est. completion date | May 25, 2020 |
Verified date | April 2023 |
Source | Vexim SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 25, 2020 |
Est. primary completion date | May 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | 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 |
Lead Sponsor | Collaborator |
---|---|
Vexim SA | Statitec |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS | Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up | 1 and 12 months follow-up | |
Secondary | Oswestry Disability Index | Screening/baseline, immediat post-op, 1, 3, 12 and 24 months | ||
Secondary | EQ-5D | Screening/baseline, immediat post-op, 1, 3, 12 and 24 months | ||
Secondary | Kyphotic angle | Screening/baseline, immediat post-op, 1, 3, 12 and 24 months | ||
Secondary | Regional Kyphotic Angle | Screening/baseline, immediat post-op, 1, 3, 12 and 24 months | ||
Secondary | Evaluation of safety through evaluation of adverse events | Screening/baseline, immediat post-op, 1, 3, 12 and 24 months | ||
Secondary | Costs comparison of overall treatments | Screening/baseline, immediat post-op, 1, 3, 12 and 24 months |
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