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SpineJack® Versus Conservative Treatment Study

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ClinicalTrials.gov Identifier: NCT02657265
Recruitment Status : Active, not recruiting
First Posted : January 15, 2016
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
MedPass International
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Spinal Fractures Vertebral Compression Fractures Back Injuries Trauma Device: SpineJack system Device: Conservative management Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. VAS [ Time Frame: Mean Visual Analogue Scale (VAS) back pain score: change from baseline to 12 months follow-up ]

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  2. EQ-5D [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  3. Kyphotic angle [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  4. Regional Kyphotic Angle, [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  5. Evaluation of safety through evaluation of adverse events [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  6. Costs comparison of overall treatments [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657265


Locations
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France
VEXIM SA
Balma, France, 31130
Sponsors and Collaborators
Vexim SA
MedPass International
Investigators
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Study Director: Marie-Pierre HONTAS Vexim SA

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Responsible Party: Vexim SA
ClinicalTrials.gov Identifier: NCT02657265     History of Changes
Other Study ID Numbers: EU2014-09
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Compression
Spinal Fractures
Back Injuries
Wounds and Injuries
Spinal Injuries