gms | German Medical Science

Objective: The results of clinical trials are often difficult to extrapolate to the eventual use of a therapy in a less controlled setting. A single German hospital was an early adopter of an anular closure prosthesis, participating in a randomized, clinical trial (RCT) setting and using the device commercially in "real world" use. Thus, this site is uniquely positioned to evaluate and compare: 1) discectomy only patients via the RCT; 2) patients implanted with Barricaid in the RCT and 3) patients implanted with Barricaid in a non-trial setting. The objective of this study is to evaluate reoperation and symptomatic reherniation rates for these three patient populations.

Method: The "Barricaid" is an anular closure prosthesis aimed at reducing reherniation rates by mechanically covering the anular defect through which a herniation has occurred. A German hospital has been enrolling patients in a multi-national RCT under specific inclusion/exclusion criteria, including minimum VAS leg pain and Oswestry Disability Index (ODI) ≥40/100 and 6 weeks of conservative care. This same site has implanted additional patients through ist normal standard of care for herniation patients. These "real world" patients included patients which met all RCT criteria as well as some that were operated on outside of study inclusion criteria.

Results: Data from the ongoing RCT were derived from a safety analysis performed in October 2014. 21 control (Group RCT-C) and 19 Barricaid (Group RCT-B) patients were enrolled since 2011. 174 real world patients (Group RW-B) were implanted with the Barricaid since 2009. The average latest follow-up was slightly longer in the RCT patients. Reoperation and symptomatic reherniation rates are shown in the table below, with the RCT-B and RW-B groups exhibiting lower rates in comparison to RCT-C. RCT-C RCT-B RW-B Symptomatic Reherniation Rate 6/21 (29%) 0/19 (0%) 7/174 (4%) Reoperation Rate 4/21 (19%) 0/19 (0%) 9/174 (5%) Average Latest Follow-up (range, months) 15.5 (1.5 - 24) 16.6 (3 - 24) 12 (0 - 46).

Conclusions: RCT-B patients exhibited lower reherniation and reoperation rates and greater improvements in clinical outcomes over both RCT-C and RW-B patients. Relative to RCT-C, these data support the effectiveness and safety of the Barricaid. Relative to RW-B, the data support the notion that the "ideal" conditions and patient selection experienced in a clinical trial are difficult to translate to actual practice.