Integra LifeSciences Holdings Corporation (Integra Lifesciences) has suspended the patient enrollment in the clinical study of DuraGen Plus Adhesion Barrier Matrix. The goal of the study is to evaluate the safety and effectiveness as an adhesion barrier in spinal surgery. The company analyzed the interim results of the clinical trial.
The conclusion from the analysis is that a significantly larger number of patients than originally estimated for in the current protocol would be necessary to demonstrate a statistically significant difference between the control arm (surgery alone) and the study arm (DuraGen Plus Adhesion Barrier Matrix) for either of the two primary endpoints, pain/functional outcomes and the formation of scar as determined by magnetic resonance imaging (MRI).
Accordingly, the company has suspended recruitment and enrollment of new patients into the trial. The company is engaged in talk with the US Food and Drug Administration (FDA) to determine the extent to which the trial will continue for patients already enrolled, and with the investigators to determine the potentially significant scientific value in data developed in the trial to date.
The safety profile of the DuraGen product was well-characterized during the study, and safety considerations played no part in the decision to suspend new enrollment in the clinical trial.
This result does not disprove the fundamental science behind the collagen matrix technology, which is known to suppress the scar response. After the settlement of obligations, the company plans to conduct other possible studies to prove the effectiveness of its collagen matrix technology for spinal surgery or related indications.
An independent group of statisticians conducted the interim futility analysis in order to monitor the progress of the clinical trial and to determine whether the study will meet the objectives of the co-primary endpoints that were established under the protocol for the clinical trial and approved by the FDA under an Investigational Device Exemption (IDE).