SpineJack® Versus Conservative Treatment Study (SPICO Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-13

Study Completion Date

2020-05-25

Brief Summary

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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.

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Detailed Description

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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

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Spinal Fractures Vertebral Compression Fractures Back Injuries Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SpineJack® system

Spine fracture management

Group Type EXPERIMENTAL

SpineJack system

Intervention Type DEVICE

Spine fracture management for traumatic vertebral compression fracture

Conservative management

Surgical corset according to measurement's impression, rigid corset with sternal support

Group Type ACTIVE_COMPARATOR

Conservative management

Intervention Type DEVICE

Surgical corset according to measurement's impression, rigid corset with sternal support

Interventions

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SpineJack system

Spine fracture management for traumatic vertebral compression fracture

Intervention Type DEVICE

Conservative management

Surgical corset according to measurement's impression, rigid corset with sternal support

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient must have signed the consent form
2. Male or Female between 18 and 60 years old
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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No