Austin Neurosurgeons Clinical Research Study on P-15L Bone Graft
- Austin Neurosurgeons
- Nov 20, 2020
- 2 min read
P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Dr. Daniel Peterson is a board-certified neurosurgeon with over 13 years of clinical research experience and 27 years of clinical practice treating conditions of the spine.
Under Dr. Peterson’s leadership, Austin Neurosurgeons is currently enrolling patients in a variety of clinical research trials. The trials are being conducted to investigate a variety of medical devices and surgical techniques; such as synthetic bone graft, fusion cages, and artificial disc replacements.
Dr. Peterson is constantly looking for the best ways to treat his patients and is leading the way in research and development of such medical breakthroughs. One exciting study that is now available to his patients is that of a new bone graft designed for instrumented interbody fusion of the lumbar spine .
The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery.
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.
If you are interested in learning more, schedule an appointment with our office at 512-314-3888
To learn more about the study please visit:
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