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SpineJack® Versus Conservative Treatment Study (SPICO Study)

Primary Purpose

Spinal Fractures, Vertebral Compression Fractures, Back Injuries

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

SpineJack system

Conservative management

About this trial

This is an interventional treatment trial for Spinal Fractures

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient must have signed the consent form
Male or Female between 18 and 60 years old
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).
Vertebral kyphosis angle >10°
Patient is eligible to treatment with brace
Technical feasibility of a SpineJack® procedure and brace 1 to 5 days after screening/baseline

Exclusion Criteria:

Vertebral fracture more than 10 days old
Spontaneous osteoporotic vertebral fracture
Neurological signs or symptoms related to the vertebral fracture
Vertebral kyphosis angle >30°
Active systemic or local infection at baseline
Patient with substance abuse
History of intolerance or allergic reaction to titanium or acrylic compounds
Fracture geometry making the insertion of the implant impossible
Malignant lesions
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*
Patient on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
Patient presenting with a non-correctable spontaneous or therapeutic coagulation disorder.
Non-compliant patient: Impossibility to participate in the study and to be followed-up for 2 years.
Participating in any other investigational study
Female patients who are pregnant, breastfeeding, or planning to get pregnant during the course of the study
Patient not affiliated to social security *: including but not limited to patients with contraindications for general anesthesia (surgeon expertise)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SpineJack® system

Conservative management

Arm Description

Spine fracture management

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

Outcomes

Primary Outcome Measures

VAS

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

Secondary Outcome Measures

Oswestry Disability Index

EQ-5D

Kyphotic angle

Regional Kyphotic Angle

Evaluation of safety through evaluation of adverse events

Costs comparison of overall treatments

Full Information

NCT ID

NCT02657265

First Posted

January 5, 2016

Last Updated

April 17, 2023

Sponsor

Vexim SA

Collaborators

Statitec

1. Study Identification

Unique Protocol Identification Number

NCT02657265

Brief Title

SpineJack® Versus Conservative Treatment Study (SPICO Study)

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

January 13, 2016 (Actual)

Primary Completion Date

May 27, 2019 (Actual)

Study Completion Date

May 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vexim SA

Collaborators

Statitec

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: SpineJack® system 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SpineJack® system

Arm Type

Experimental

Arm Description

Spine fracture management

Arm Title

Conservative management

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

SpineJack system

Intervention Description

Spine fracture management for traumatic vertebral compression fracture

Intervention Type

Device

Intervention Name(s)

Conservative management

Intervention Description

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

Primary Outcome Measure Information:

Title

VAS

Description

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

Time Frame

1 and 12 months follow-up

Secondary Outcome Measure Information:

Title

Oswestry Disability Index

Time Frame