The aim of this study was to investigate complication rates and types following allograft reconstruction and discuss unique considerations for management. Methods: Seventy-four consecutive patients underwent large segment allograft reconstruction following resection of primary musculoskeletal tumors from 1991 to 2016. Mean patient age was 32 ± 20 years (range, 5-71 years). Minimum follow-up was 2 years unless patients were lost to disease prior. Mean follow-up was 105 months. Results: Thirty-five patients had complications requiring subsequent surgery at a mean of 30 months (range, 1-146 months) post-operatively. Individual complication rates were 29%, 50%, and 42% for Allograft Prosthetic Composite, Intercalary, and Osteoarticular allograft reconstruction, respectively. Risk factors for complication included age less than 30 (OR 4.5; p = 0.002), male gender (OR 2.8; p = 0.031), chemotherapy (OR 4.4; p = 0.003), lower extremity disease (OR 3.4; p = 0.025). In patients with complications, limb-retention rate was 91% and mean MSTS scores were 23.6. Conclusion: Despite considerable complication rates, management with a systematic approach results in successful outcomes with limb-retention greater than 90% and mean MSTS scores of 79%. In carefully selected patients, allografts provide a reliable method of reconstruction with treatable complications occurring at a mean of 30 months.
BackgroundCustomizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient’s surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place.PurposeThe objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol.MethodsAn institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013–2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval.ResultsThe average patient age was 12 years old (7–21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7–21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7–19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act’s expanded access provisions.ConclusionsEstablishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated process of obtaining customizable orthopaedic implants for orthopaedic oncology patients.Level of evidenceRetrospective case series, Level IV. See the Guidelines for authors for a complete description of levels of evidence.
Background: Orthopaedic surgeons rely on radiographs to assist in the evaluation and treatment of patients. The technological advances of smartphones have allowed data to be transferred quickly and viewed from remote locations. The diagnostic accuracy of viewing radiographs on smartphones remains unproven. As such, this study aimed to evaluate the ability of smartphones to allow surgeons to correctly diagnose and interpret radiographs of ankle fractures on one of the most popular smartphones, an Apple iPhone 4S (Apple Inc, Cupertino, CA, USA). Methods: Using the smartphone, individual pictures were taken of anteroposterior, mortise, and lateral radiographs of 20 ankle fractures. These images were then evaluated through 10 questions that included acceptable quality, presence and displacement of fibula, medial malleolus, and posterior malleolar fractures, ankle subluxation, syndesmotic disruption, Lauge-Hansen classification, and the need for open reduction and internal fixation. Results were compared to the same radiographs viewed on a picture archiving and communication system (PACS) workstation. Results: Ten orthopaedic surgery residents and five orthopaedic surgery attendings evaluated the radiographs and answered a total of 6000 questions. When comparing the responses between those images viewed on the smartphone versus those viewed on the PACS workstation, 826 differences were found. After analysis of both interobserver and intraobserver reliability, a significant difference was found between viewing modalities, with the smartphone found to be not as reliable as the PACS workstation. However, when looking at the single question of whether or not the fracture would require operative fixation, no significant difference was found between the use of a smartphone or PACS workstation. Conclusions: The smartphone images demonstrated a reliable prediction of the proper treatment for the 20 ankle fractures despite noted differences between the two viewing modalities.
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