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| Name | Class |
|---|---|
| Statitec | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpineJack® system | Experimental | Spine fracture management |
|
| Conservative management | Active Comparator | Surgical corset according to measurement's impression, rigid corset with sternal support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpineJack system | Device | Spine fracture management for traumatic vertebral compression fracture |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS | Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up | 1 and 12 months follow-up |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc Vital, Prof. | Hopital Pellegrin - Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Jean Minjoz Besancon | Besançon | France | ||||
| CHU de Bordeaux - Hopital Pellegrin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38427996 | Derived | 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. |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Conservative management | Device | Surgical corset according to measurement's impression, rigid corset with sternal support |
|
| 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 |
| 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 |