Clinical trial NCT02657265: SpineJack® Versus Conservative Treatment Study (SPICO Study)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Fractures
Vertebral Compression Fractures
Back Injuries
Trauma
Lead sponsor: Vexim SA
Sponsor class: INDUSTRY
Collaborators: name: Statitec
First posted: 2016-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: VAS
timeFrame: 1 and 12 months follow-up
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
measure: EQ-5D
timeFrame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
measure: Kyphotic angle
timeFrame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
measure: Regional Kyphotic Angle
timeFrame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
measure: Evaluation of safety through evaluation of adverse events
timeFrame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
measure: Costs comparison of overall treatments
timeFrame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Hopital Jean Minjoz Besancon
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hopital Pellegrin
city: Brest
country: France
facility: CHU Brest
city: Chambéry
country: France
facility: Centre Hospitalier De Chambéry
city: Dijon
country: France
facility: CHU de Dijon
city: Marseille
country: France
facility: APHM, Hopital Nord Marseille
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen-Hopital Charles Nicolle
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Privé Saint Grégoire
Study officials:
affiliation: Hopital Pellegrin - Bordeaux
name: Jean-Marc Vital, Prof.
role: PRINCIPAL_INVESTIGATOR
References: