Using OsteoCleanse(TM), the resultant autografts
are placed in a custom container, shipped to LifeNet Health, disinfected, labeled, and stored until re-implantation.
Assessment of computerized tomography (CT) scans at six weeks demonstrated 39% of GEM OS1 patients versus 33% of autograft
patients exhibited fusion as defined by osseous bridging of greater than 50% of the joint surface, while at 12 weeks 69% of GEM OS1 and 50% of autograft
patients had fused.
The data available thus far support the primary objective of the study which is to find a safe and effective alternative to autograft
in foot and ankle fusion surgeries.
Our distribution partner, Joint Solutions, has already begun the process of familiarizing orthopedic surgeons with Augment Bone Graft and the patient benefits of using Augment as an alternative to performing a second surgery to collect autograft
There are alternatives to autograft
and its associated risks, some of which may be more effective in the formation of bridging bone," said Dr.
In November 2009, BioMimetic received approval from Health Canada to begin marketing Augment as an alternative to the use of autograft
in foot and ankle fusion indications in Canada.
Nicholas Abidi will discuss results of a study identifying the costs related to harvesting autograft
in foot and ankle fusions.
4] is a new therapeutic alternative to autograft
for Foot and Ankle surgery, which avoids secondary surgical sites necessary to harvest autograft
tissue," said Tom Popeck, Vice President and General Manager, Stryker Foot and Ankle.
The study is a randomized controlled non-inferiority trial comparing Augment Injectable to autograft
, with the two treatments randomized 2:1, respectively.
The PMA application is supported by data from a pivotal clinical trial comparing i-FACTOR bone graft to autograft
in anterior cervical discectomy and fusion (ACDF) procedures.
Daniels commented on the results of the trial, "Augment Injectable Bone Graft demonstrated at least equivalent, and potentially faster, healing outcomes compared to autograft
in this study.
The purpose of the study described in this article was to evaluate the results of autograft
temporalis fascia myringoplasty with a superiorly based meatal skin and tympanic membrane epithelium flap.