Published Clinical Evidence

Eur Spine J (2013) 22:1030–1036
The high-risk discectomy patient: prevention of reherniation in patients with large anular defects using an anular closure device
GJ Bouma, M Barth, D Ledic, M Vilendecic Abstract »

Korean J Spine 9(4):340-347, 2012 
Primary Limited Lumbar Discectomy with an Annulus Closure Device: One-Year Clinical and Radiographic Results from a Prospective, Multi-Center Study 
M Lequin, M Barth, C Thomé, GJ Bouma Abstract »

J Neurol Surg A Cent Eur Neurosurg. 2013 May 13, DOI: 10.1055/s-0033-134116
Cost Savings Associated with Prevention of Recurrent Lumbar Disc Herniation: A Multi-Center Prospective Cohort Study 
SL Parker, G Grahovac, D Vukas, D Ledic, M Vilendecic, MJ McGirt Abstract »

BSD Journal of Spinal Disorders and Techniques Publish Ahead of Print; DOI:10.1097/BSD.0b013e3182956ec5
Effect of a novel annular closure device (Barricaid) on same level recurrent disc herniation and disc height loss after primary lumbar discectomy: Two-year results of a multi-center prospective cohort study
Parker et al Abstract »

Clin Neurol Neurosurg. 2013, DOI: 10.1016/j.clineuro.2013.01.007
Protecting Facet Joints Post-Lumbar Discectomy: Barricaid Annular Closure Device Reduces Risk of Facet Degeneration.
M Trummer, S Eustacchio, M Barth, PD Klassen, S Stein Abstract »

Spine (2013) 38(10) pp E587–E593
Can prevention of a re-herniation be investigated?: Establishment of a herniation model and experiments with an anular closure device 
HJ Wilke, L Widmann, F Heuer, N Graf, S Rath Abstract »

J Neurol Surg A Cent Eur Neurosurg. DOI: 10.1055/s-0034-1393930
Effect of Anular Closure on Disk Height Maintenance and Reoperated Recurrent Herniation Following Lumbar Diskectomy: Two-Year Data. 
D Ledić, D Vukas, G Grahovac, M Barth, GJ Bouma, M Vilendecic Abstract »




PUBLISHED EVIDENCE FOR THE BARRICAID®

Please click here to download complete list of published clinical evidence for Barricaid®.



ONE AND TWO-YEAR OUTCOME SETS FROM PUBLISHED PROSPECTIVE STUDIES


Results

With a minimum follow-up of 12 months, Barricaid® patients have statistically superior outcomes in two important endpoints for discectomy - recurrence risk and disc height maintenance.

DISC HEIGHT MAINTENANCE

*Compared to pre-op disc height

IMPROVED PATIENT REPORTED OUTCOMES

While the studies were not powered to demonstrate significant improvement in patient directed outcomes, strong trends and significant improvements with the Barricaid® are emerging.

VAS LOW BACK

VAS IPSILATERAL LEG SCORE

OSWESTRY DISABILITY INDEX

All p-values calculated by Wilcoxon-Rank sum (non-parametric)

Overall Success at 1 Year

With complete data at 1 year for all studies, patient success measured in terms of accepted minimal clinically significant improvement is statistically in favor of Barricaid® use.

p-value based on 1-sided Fisher’s Exact

Ongoing Clinical Trials

In Europe

Multi-Center, Multi-National, Randomized, Prospective, Controlled Superiority Study of the Barricaid® vs. Limited Discectomy Alone

In December 2010, Intrinsic Therapeutics initiated one of the largest spine studies ever run to demonstrate the clear benefit of using the Barricaid® in limited discectomy patients.

Contributing centers

Between 15-20 clinical centers are contributing to the trial in Germany, the Netherlands, Belgium, Austria and potentially other nations.

Patient population

The trial is a 1:1 intra-operative randomized trial comparing Barricaid® versus limited discectomy alone. The trial uses a Bayesian statistical plan which allows for the enrollment of between 400 – 800 patients. 

Enrolled patients include those with maximum potential to benefit from preservation of their remaining disc with the Barricaid® and will have a minimum disc height as well as a minimum defect size, lack of a reoperation and reherniation at the target level.

Endpoints

To be judged a success, Barricaid® patients will need to demonstrate statistical superiority in the study´s two co-primary endpoints:

  • Reherniation free survival
  • A composite endpoint of patient outcomes including improvement in leg pain, Oswestry Disability Index (ODI), maintenance of disc height, and lack of a reoperation at the target level.

Follow-up

This study will be the most comprehensive study of discectomy patients performed to date, collecting all relevant clinical as well as radiographic data. The resulting data set will serve not only to demonstrate the superiority of the Barricaid®, but to analyze the impact of pre-operative data and intra-operative technique on the outcomes of discectomy.

Discussion

More information on this trial can be found at www.Barricaid-Study.eu

Intrinsic Therapeutics is also committed to assisting interested centers in conducting both reimbursement studies and independent performance trials. Please contact us via our Contact form and we will have someone get back to you to discuss your interests.
 

 

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