NCT02657265

SpineJack® Versus Conservative Treatment Study (SPICO Study)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Vexim SA · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Fractures
• Vertebral Compression Fractures
• Back Injuries
• Trauma

Interventions

Type	Name	Description
DEVICE	SpineJack system	Spine fracture management for traumatic vertebral compression fracture
DEVICE	Conservative management	Surgical corset according to measurement's impression, rigid corset with sternal support

Timeline

• Start date: 2016-01-13
• Primary completion: 2019-05-27
• Completion: 2020-05-25
• First posted: 2016-01-15
• Last updated: 2023-04-20

Locations

9 sites across 1 country: France