SpineJack® Versus Conservative Treatment Study (SPICO Study)

Not Applicable

Completed

• Conditions: Trauma; Spinal Fractures; Back Injuries; Vertebral Compression Fractures
• Interventions: Device: SpineJack system; Device: Conservative management

• Registration Number: NCT02657265
• Lead Sponsor: Vexim SA

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.

Study Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-12
• Study Start: 2016-01-13
• Study First Posted: 2016-01-15
• Primary Completion: 2019-05-27
• Study Completion: 2020-05-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SpineJack® system	SpineJack system	Spine fracture management
Conservative management	Conservative management	Surgical corset according to measurement's impression, rigid corset with sternal support

Primary Outcome Measures

Name	Time	Method
VAS	1 and 12 months follow-up	Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up

Secondary Outcome Measures

Name	Time	Method
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
Costs comparison of overall treatments	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

Trial Locations

Locations (9)

Hopital Jean Minjoz Besancon; 🇫🇷 Besançon, France

CHU de Bordeaux - Hopital Pellegrin; 🇫🇷 Bordeaux, France

Centre Hospitalier De Chambéry; 🇫🇷 Chambéry, France

CHU Brest; 🇫🇷 Brest, 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, France