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SpineJack® Versus Conservative Treatment Study (SPICO Study)

NCT02657265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-04-20

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Statitec

    collaborator INDUSTRY

  • Vexim SA

    lead INDUSTRY

Principal Investigators

  • Jean-Marc Vital, Prof. · Hopital Pellegrin - Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-13
Primary Completion
2019-05-27
Completion
2020-05-25

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657265 on ClinicalTrials.gov