Complications following allograft reconstruction for primary bone tumors: Considerations for management.

INTRODUCTION: 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 ±â€¯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.

Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.

BACKGROUND: Customizable 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. PURPOSE: The 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. METHODS: An 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. RESULTS: The 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. CONCLUSIONS: Establishment 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 EVIDENCE: Retrospective case series, Level IV. See the Guidelines for authors for a complete description of levels of evidence.

Heterotopic Ossification and Entrapment of the Tibial Nerve Within the Tarsal Tunnel: A Case Report.

Heterotopic ossification has been reported to occur after musculoskeletal trauma (including orthopedic procedures). This has been known to cause nerve entrapment syndromes and persistent pain, limiting joint mobility. We present a case of a 19-year old female collegiate athlete who had previously undergone ankle arthroscopy and arthrotomy to remove 2 ossicles. At approximately 1 year postoperatively, the patient developed pain when planting and pivoting her foot. Imaging revealed a radiodense lesion at the posteromedial ankle consistent with heterotopic ossification and entrapment of the tibial nerve within the tarsal tunnel. The patient underwent surgical resection and postoperative indomethacin prophylaxis. At the 1-year follow-up visit, the patient remained asymptomatic, without evidence of recurrence of the heterotopic ossification. In our review of the published data, we found no previously reported cases of heterotopic ossification causing entrapment of the tibial nerve within the tarsal tunnel. In the present case report, we describe this rare case and the postulated etiologies and pathophysiology of this disease process. In addition, we discuss the clinical signs and symptoms and recommended imaging modalities and treatment.