SpineJackĀ® Versus Conservative Treatment Study (SPICO Study) (NCT02657265) | Clinical Trial Compass
CompletedNot Applicable
SpineJackĀ® Versus Conservative Treatment Study (SPICO Study)
France100 participantsStarted 2016-01-13
Plain-language 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. SpineJackĀ® system
2. Conservative Orthopedic Management consisting of brace and pain medication.
Who can participate
Age range18 Years ā 60 Years
SexALL
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Inclusion criteria
ā. Patient must have signed the consent form
ā. Male or Female between 18 and 60 years old
ā. 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).
ā. Vertebral kyphosis angle \>10Ā°
ā. Patient is eligible to treatment with brace
ā. Technical feasibility of a SpineJackĀ® procedure and brace 1 to 5 days after screening/baseline
Exclusion criteria
ā. Vertebral fracture more than 10 days old
ā. Spontaneous osteoporotic vertebral fracture
ā. Neurological signs or symptoms related to the vertebral fracture
ā. Vertebral kyphosis angle \>30Ā°
ā. Active systemic or local infection at baseline
ā. Patient with substance abuse
ā. History of intolerance or allergic reaction to titanium or acrylic compounds