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SpineJack® Versus Conservative Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date January 25, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
VAS [ Time Frame: Mean Visual Analogue Scale (VAS) back pain score: change from baseline to 12 months follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02657265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Oswestry Disability Index [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  • EQ-5D [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  • Kyphotic angle [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  • Regional Kyphotic Angle, [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  • Evaluation of safety through evaluation of adverse events [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
  • Costs comparison of overall treatments [ Time Frame: Screening/baseline, immediat post-op, 1, 3, 12 and 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SpineJack® Versus Conservative Treatment Study
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Fractures
  • Vertebral Compression Fractures
  • Back Injuries
  • Trauma
Intervention  ICMJE
  • Device: SpineJack system
    Spine fracture management for traumatic vertebral compression fracture
  • Device: Conservative management
    Surgical corset according to measurement's impression, rigid corset with sternal support
Study Arms  ICMJE
  • Experimental: SpineJack® system
    Spine fracture management
    Intervention: Device: SpineJack system
  • Active Comparator: Conservative management
    Surgical corset according to measurement's impression, rigid corset with sternal support
    Intervention: Device: Conservative management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 12, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657265
Other Study ID Numbers  ICMJE EU2014-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vexim SA
Study Sponsor  ICMJE Vexim SA
Collaborators  ICMJE MedPass International
Investigators  ICMJE
Study Director: Marie-Pierre HONTAS Vexim SA
PRS Account Vexim SA
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP