stereoisomers of PLA has been shown to decrease these soft-tissue reactions. The incidence of infections has also been shown to be comparable in patients with resorbable implants compared with traditional metallic implant devices. 2 Animal Spine Studies Interbody cages for human spinal fusion have been used successfully for several years. High fusion rates have been achieved with their use in single-level applications and in two-level procedures supplemented with posterior instrumentation. 1, 11, 35, 41, 44 The use of interbody cages or spacers in conjunction with bone
Alexander R. Vaccaro and Luke Madigan
Matthew M. Robbins, Alexander R. Vaccaro and Luke Madigan
The use of bioabsorbable implants in spine surgery is expanding at a rapid pace. These implants are mimicking the roles of traditional metallic devices and are demonstrating similar efficacy in terms of maintaining stability and acting as carriers for grafting substances. Biomechanical studies have demonstrated their ability to stabilize effectively a degenerative cervical and lumbar motion segment. In numerous animal models, researchers have illustrated the ability of bioabsorbable implants to function satisfactorily as an interbody spacer and to achieve satisfactory bone fusion. Investigators have explored various opportunities for these implants to replace their metallic counterparts in clinical studies conducted in humans. The gradual resorption of these implants appears effectively to transfer gradual loads to the grafting substances promoting the biological mechanisms of fusion.
Novel uses of bioabsorbable technology are constantly evolving. Their future as a carrier of biological agents such as bone morphogenetic proteins and bone graft extenders, their radiolucency, and their eventual resorption make them an ideal implant for use in spinal degenerative disease.
Gregory D. Schroeder, Christopher K. Kepler, MD MBA and Alexander R. Vaccaro
none of these patients were undergoing deformity surgery. Similarly, the revision rate for axial interbody fusion is similar to that identified in the multicenter prospective, randomized, controlled investigational device exemption study of the FlexiCore artificial disc (Stryker Spine). 24 Sasso et al. reported a 35% revision rate at 2 years in patients who had undergone an ALIF, and in the current study only 14.42% of patients who had undergone axial interbody fusion required a revision. Even patients in the prospective subgroup analysis (22.56%) and the
Pascal Jabbour, Michael Fehlings, Alexander R. Vaccaro and James S. Harrop
younger patients, the geriatric population often cannot tolerate this technique due to airway and swallowing dysfunction as well as the significant weight of these devices on their frames. An additional difficulty with this fracture in the elderly is the significant incidence of pseudarthrosis, even despite rigid (halo vest) immobilization techniques. Therefore, many surgeons have advocated rigid internal fixation to promote the highest rates of arthrodesis. Nevertheless, the use of a cervical collar is still an option for older patients, as long as the surgeon and
Alpesh A. Patel, Peter G. Whang, Andrew P. White, Michael G. Fehlings and Alexander R. Vaccaro
a manuscript detailing the outcomes of a new medical device. As required, the researcher and all coauthors submit signed documentation disclosing all financial relationships including those related to the investigational device. The article undergoes peer review and is accepted for publication. Shortly after publishing the article, the journal editors are contacted by both the individuals and the institutions involved with the study. The coinvestigators voice concerns over the accuracy of the data presented in the final paper. The academic institution of the
Alexander R. Vaccaro, John A. Carrino, Benjamin H. Venger, Todd Albert, Peter M. Kelleher, Alan Hilibrand and Kush Singh
–bone surfaces required to heal as well as the increased instability/micromotion that results from multilevel disc excision. 22, 23 Well-designed controlled prospective clinical trials have shown that the addition of a static ACP has resulted in an improved fusion rate with less graft subsidence. 41, 42 A new trend in anterior plating technology is the concept of dynamization through a collapsing anterior fixation device. 9 This may occur through plate on screw sliding, or the use of nonlocked variable-angle screws or a telescoping plate. The value of this technology is
Alexander R. Vaccaro, Matthew M. Robbins, Luke Madigan, Todd J. Albert, William Smith and Alan S. Hilibrand
In this pilot study the authors assessed the efficacy of bioabsorbable interbody spacers in the treatment of cervical degenerative disease. Metallic cages or interbody spacers have been widely used in the treatment of degenerative and traumatic cervical disease. Bioabsorbable technology has been used to develop a resorbable cage that can eliminate the complications and drawbacks seen with the use of traditional metallic implants. In general clinical practice bioabsorbable implants have shown the ability to degrade safely while demonstrating optimal imaging characteristics as a result of their radiolucency, and these devices eliminate stress shielding by their gradual dissolution.
This study is a retrospective evaluation of charts and x-ray films obtained in the first eight patients who underwent an anterior cervical decompression and fusion procedure with placement of a bioabsorbable interbody spacer and anterior cervical plate. All patients were treated in one surgeon's practice and had a minimum follow-up period of at least 6 months. At a follow-up interval of approximately 7 months, five patients exhibited an excellent result and three had a good result; no patient was noted to have a satisfactory or poor outcome according to the Odom criteria at their most recent follow-up visit. Seventeen (94%) of 18 grafted levels appeared to be solidly fused. One patient experienced a perisurgical complication consisting of a symptomatic hematoma, which was successfully drained.
Bioabsorbable interbody spacers appear to be a safe and effective interbody implant in terms of clinical outcome and radiographically confirmed healing.
Joseph H. Piatt Jr.
, and government entities. They might also have mentioned the plaintiffs' bar and the press. Responsibility for the management of commercial bias is diffusely distributed among these entities, and events continue to demonstrate the ineffectuality of existing oversight mechanisms. A cornerstone of the scientific process is that, if methods are clearly described, new results can be confirmed or refuted by independent investigators. In the study of new drugs and especially new devices, this safeguard is largely crippled by the prohibitive costs of clinical trials
Myles Luszczyk, Justin S. Smith, Jeffrey S. Fischgrund, Steven C. Ludwig, Rick C. Sasso, Christopher I. Shaffrey and Alexander R. Vaccaro
locked plate fixation. The patient group was composed of the “control” groups from 5 separate prospective randomized FDA investigational device exemption (IDE) studies evaluating the use of an anterior cervical disc replacement device to treat cervical radiculopathy (Bryan [Medtronic Sofamor Danek], Prestige ST [Medtronic Sofamor Danek], ProDisc-C [DePuy Synthes], CerviCore [Stryker Spine], and PCM [Cervitech]). Each of these 5 studies used anterior cervical fusion with allograft and a locked anterior cervical plate as the control group. Data were obtained directly
Chang Ju Hwang, Alexander R. Vaccaro, Joseph Hong, James P. Lawrence, Jeffrey S. Fischgrund, Moulay Hicham Alaoui-Ismaili and Dean Falb
samples collected over the course of a prospective, randomized, controlled, multicenter pivotal study investigating the safety and efficacy of rhOP-1. Methods Study Design This study was performed as part of a controlled, open-label, randomized, prospective multicenter trial conducted under an FDA-approved Investigational Device Exemption. All patients had degenerative lumbar spondylolisthesis (Grade I or II, Meyerding classification) with coexistent spinal stenosis and symptoms of neurogenic claudication, as confirmed by history, physical examination, and