SpineJack® Versus Conservative Treatment Study (SPICO Study)

Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657265
• Other study ID #: EU2014-09
• Status: Completed
• Phase: N/A
• Start date: January 13, 2016
• Est. completion date: May 25, 2020

Study information

• Verified date: April 2023
• Source: Vexim SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 25, 2020
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• SpineJack system
Spine fracture management for traumatic vertebral compression fracture
• Conservative management
Surgical corset according to measurement's impression, rigid corset with sternal support

Locations

Country	Name	City	State
France	Hopital Jean Minjoz Besancon	Besançon
France	CHU de Bordeaux - Hopital Pellegrin	Bordeaux
France	CHU Brest	Brest
France	Centre Hospitalier De Chambéry	Chambéry
France	CHU de Dijon	Dijon
France	APHM, Hopital Nord Marseille	Marseille
France	CHU de Rennes	Rennes
France	CHU de Rouen-Hopital Charles Nicolle	Rouen
France	Centre Hospitalier Privé Saint Grégoire	Saint-Grégoire

Sponsors (2)

Lead Sponsor	Collaborator
Vexim SA	Statitec

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up	1 and 12 months follow-up
Secondary	Oswestry Disability Index		Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Secondary	EQ-5D		Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Secondary	Kyphotic angle		Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Secondary	Regional Kyphotic Angle		Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Secondary	Evaluation of safety through evaluation of adverse events		Screening/baseline, immediat post-op, 1, 3, 12 and 24 months
Secondary	Costs comparison of overall treatments		Screening/baseline, immediat post-op, 1, 3, 12 and 24 months