Surgeons clearly need contemporary prospective studies, like this one, that provide evidence that a specific DBM can, in fact, be used as an autograft
bone extender, as it has commonly been used in surgical procedures for years.
Of equal importance is the fact that Healos is being evaluated against autograft
, the 'gold standard' for spinal fusion procedures," he added.
We believe this product has the potential to change the way orthopedic procedures are performed and eliminate the pain and risks associated with autograft
Through the OsteoCleanse(TM) autograft
cleaning service, LifeNet Health is continuing to advance technology and offer solutions to help restore health and save lives," said Rony Thomas, LifeNet Health CEO and President.
is the only bone graft material that is taken from a patient's own body.
Donor site pain was eliminated by avoiding autograft
and operating room procedure time shortened by nearly 20% (26 minutes) with the use of the GEM OS1.
As announced previously, the study is designed as a randomized controlled non-inferiority trial comparing GEM OS1 to autograft
, with the two treatments randomized 2:1, respectively.
Lowe, who performs 400 ACL reconstructions each year, typically recommends one of three surgical procedures - the patellar tendon autograft
, the hamstring tendon autograft
or the cadaver tendon allograft.
The second abstract is entitled "Anterior Cervical Arthrodesis Without Autograft
, Allograft, or BMP-2: 75 Patients Treated with Beta-Tricalcium Phosphate Impregnated with Local Bone Marrow Aspirate.
According to preliminary analysis of the trial results, treatment with i-FACTOR showed statistically significant non-inferiority to the autograft
control group for fusion rate, neck disability index (NDI) scores, and neurological outcomes.
The primary clinical endpoint was autograft
engraftment or "take" two weeks after autograft
The study randomized 319 patients to either i-FACTOR bone graft or autograft
inside of a structural allograft ring for single-level instrumented ACDF procedures.
While effective, the use of autograft
creates significant morbidities at a previously asymptomatic harvest site.
In November 2009, BioMimetic received approval from Health Canada to begin the marketing of Augment as an alternative to the use of autograft
in foot and ankle fusion indications in Canada.
We continue to lead the effort to identify and develop innovative biologic bone graft products that may replace or augment the use of autograft
and this new study shows promise for our proprietary technology in PLIF patients.