The 35th president of the United States, John F. Kennedy (JFK), experienced chronic back pain beginning in his early 20s. He underwent a total of 4 back operations, including a discectomy, an instrumentation and fusion, and 2 relatively minor surgeries that failed to significantly improve his pain. The authors examined the nature and etiology of JFK’s back pain and performed a detailed investigation into the former president’s numerous medical evaluations and treatment modalities. This information may lead to a better understanding of the profound effects that JFK’s chronic back pain and its treatment had on his life and presidency, and even his death.
T. Glenn Pait and Justin T. Dowdy
Todd H. Lanman, J. Kenneth Burkus, Randall G. Dryer, Matthew F. Gornet, Jeffrey McConnell and Scott D. Hodges
The aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF).
A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted at 30 US centers, comparing the low-profile titanium ceramic composite-based Prestige LP ADR (n = 209) at 2 levels with ACDF (n = 188). Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative intervals to 84 months. The primary end point was overall success, a composite variable that included key safety and efficacy considerations.
At 84 months, the Prestige LP ADR demonstrated statistical superiority over fusion for overall success (observed rate 78.6% vs 62.7%; posterior probability of superiority [PPS] = 99.8%), Neck Disability Index success (87.0% vs 75.6%; PPS = 99.3%), and neurological success (91.6% vs 82.1%; PPS = 99.0%). All other study effectiveness measures were at least noninferior for ADR compared with ACDF. There was no statistically significant difference in the overall rate of implant-related or implant/surgical procedure–related adverse events up to 84 months (26.6% and 27.7%, respectively). However, the Prestige LP group had fewer serious (Grade 3 or 4) implant- or implant/surgical procedure–related adverse events (3.2% vs 7.2%, log hazard ratio [LHR] and 95% Bayesian credible interval [95% BCI] −1.19 [−2.29 to −0.15]). Patients in the Prestige LP group also underwent statistically significantly fewer second surgical procedures at the index levels (4.2%) than the fusion group (14.7%) (LHR −1.29 [95% BCI −2.12 to −0.46]). Angular range of motion at superior- and inferior-treated levels on average was maintained in the Prestige LP ADR group to 84 months.
The low-profile artificial cervical disc in this study, Prestige LP, implanted at 2 adjacent levels, maintains improved clinical outcomes and segmental motion 84 months after surgery and is a safe and effective alternative to fusion.
Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)
Ralph J. Mobbs, Marc Coughlan, Robert Thompson, Chester E. Sutterlin III and Kevin Phan
There has been a recent renewed interest in the use and potential applications of 3D printing in the assistance of surgical planning and the development of personalized prostheses. There have been few reports on the use of 3D printing for implants designed to be used in complex spinal surgery.
The authors report 2 cases in which 3D printing was used for surgical planning as a preoperative mold, and for a custom-designed titanium prosthesis: one patient with a C-1/C-2 chordoma who underwent tumor resection and vertebral reconstruction, and another patient with a custom-designed titanium anterior fusion cage for an unusual congenital spinal deformity.
In both presented cases, the custom-designed and custom-built implants were easily slotted into position, which facilitated the surgery and shortened the procedure time, avoiding further complex reconstruction such as harvesting rib or fibular grafts and fashioning these grafts intraoperatively to fit the defect. Radiological follow-up for both cases demonstrated successful fusion at 9 and 12 months, respectively.
These cases demonstrate the feasibility of the use of 3D modeling and printing to develop personalized prostheses and can ease the difficulty of complex spinal surgery. Possible future directions of research include the combination of 3D-printed implants and biologics, as well as the development of bioceramic composites and custom implants for load-bearing purposes.