Enrollment is now closed in this study to assess the safety and efficacy of Augment for the treatment of foot and ankle fusions as compared to autograft, the current gold standard for bone grafting in this type of surgery.
The study was designed to enroll 396 patients, however enrollment in the trial continued through December 31, 2008 to accommodate those additional patients who had already been consented into the study and scheduled for surgery.
The North American pivotal study is designed as a randomized controlled non-inferiority trial comparing Augment to autograft, with the two treatments randomized 2:1, respectively. The primary endpoint of the study is the percent of patients fused, as measured by CT scans, at six months.
Secondary endpoints include clinical assessment, plain film radiographic evaluation and several functional and pain assessments. The evaluation of all CT scans and X-rays will be done by a blinded, independent radiologist, who will assess the key parameters of radiographic fusion (bone healing).
Samuel Lynch, president and CEO of BioMimetic Therapeutics, said: We expect to be able to file the clinical data with the FDA in the fourth quarter of 2009 as the last element of our modular premarket approval (PMA) filing. The other two sections of the PMA, the preclinical and the quality/manufacturing sections, are on schedule to be filed this spring allowing time for the agency to review these data in advance of the clinical data.