SpineJack® Versus Conservative Treatment Study (SPICO Study)

Study Overview
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Brief Summary
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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: SpineJack® system Conservative Orthopedic Management consisting of brace and pain medication.

Detailed Description
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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.

Official Title
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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

Conditions
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Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Trauma

Intervention / Treatment
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* Device: SpineJack system
* Device: Conservative management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have signed the consent form Male or Female between 18 and 60 years old 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). 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 Exclusion Criteria: 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 Patient not affiliated to social security *: including but not limited to patients with contraindications for general anesthesia (surgeon expertise)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpineJack® system<br>Spine fracture management | Device: SpineJack system<br>* Spine fracture management for traumatic vertebral compression fracture<br>|
| Active Comparator: Conservative management<br>Surgical corset according to measurement's impression, rigid corset with sternal support | Device: Conservative management<br>* Surgical corset according to measurement's impression, rigid corset with sternal support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |