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

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Spinal Fractures; Back Injuries; Vertebral Compression Fractures
• Intervention / Treatment: Device: SpineJack system; Device: Conservative management

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • Hopital Jean Minjoz Besancon
  • Bordeaux, France
    • CHU de Bordeaux - Hôpital Pellegrin
  • Brest, France
    • CHU Brest
  • Chambéry, France
    • Centre Hospitalier de Chambéry
  • Dijon, France
    • CHU de Dijon
  • Marseille, France
    • APHM, Hopital Nord Marseille
  • Rennes, France
    • CHU de Rennes
  • Rouen, France
    • CHU de Rouen-Hopital Charles Nicolle
  • Saint-Grégoire, France
    • Centre Hospitalier Privé Saint Grégoire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Vexim SA
• Collaborators: Statitec
• Investigators: Principal Investigator: Jean-Marc Vital, Prof., Hôpital Pellegrin - Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2016
• Primary Completion (Actual): May 27, 2019
• Study Completion (Actual): May 25, 2020

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Fractures, Bone; Spinal Fractures; Fractures, Compression; Back Injuries
• Other Study ID Numbers: EU2014-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No