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NCT07221916
A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
NCT06238076
Fibula free flap is the gold standard for mandibular reconstruction. The shape of the fibula requires osteotomy that can be performed with a custom surgical guide. The use of surgical guide shorten surgical time, enhances the precision of the surgeon and reduces morbidity. Since 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements, which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide. The aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide.
NCT05672056
Stock reconstruction plates have been used for decades and represent a tried-and-true alternative to custom plating. Stock plates are readily available, are cost effective, and can be accurately bent before surgery, particularly when using stereolithographic models. Unfortunately, the use of stock plates typically precludes the utilization of predictive holes; this can make inset more difficult as the plates do not precisely match the native mandibular contour. Previous descriptions of fabricating predictive holes with stock plates have been inaccurate and inefficient. We aim with conducting this research to improve on the ability of pre-bent stock plates of reproducing the VSP in the operating theater allowing accurate native mandible fixation, accurate fibular segments harvest and accurate inset of the reconstruction in lieu of using the expensive alternative of PSI, thus expanding the use of VSP in mandibular reconstruction in resource limited institutions.
NCT04219683
Segmental mandibulectomy, often employed for resection of a tumour, and occasionally for trauma, osteoradionecrosis, or osteomyelitis, adversely affects patient's quality of life (QoL) to a varying degree. It inflicts a significant defect in the head and neck region, impacting on facial appearance, and the functions of speech, malocclusion, mastication, swallowing, and health-related QoL. Mandible resection thus creates a significant impact on a patient's life, both aesthetically as well as functionally. Restoration of the defects following resection of any part of the mandible presents a challenging problem for reconstructive surgeons. Since the introduction of fibula free flap (FFF) by Taylor in 1975, it has become the most popular choice for mandible reconstruction. Hidalgo popularized the FFF, and reported on its versatility with satisfactory outcomes. The utility and techniques of free flap mandible reconstruction have advanced in the past 2 decades, with success rate up from 82.6% to 100%. As the longest bone segment available for reconstructive purpose, FFF is known for its wide variety of applications, following mandible resection, including angle-to-angle reconstruction. The fibula-free flap is currently considered the most popular, 'the gold standard and the workhorse flap' for mandibular reconstruction. However, because of the limited diameter of the fibula flap compared with the height of the mandible, vertical distance between the reconstructed segment and the occlusal plane can be substantial. This is a particular problem in the dentate mandible, especially when rehabilitation with dental implants or an implant-borne denture is contemplated. Insufficient bone height leads to overloading of osteointegrated implants and endangers the longevity of the prosthetic restoration. Insufficient bone height and poor soft tissue overlying the bone flap also create an unfavourable environment for the tissue-borne prosthesis. Such issues are particularly acute in patients with intact alveolar bone and dentition at healthy sites. The double-barrel technique, distraction osteogenesis, non-vascularized bone grafts, and guided-bone regeneration have all been used to resolve this. The double-barrel technique is a good method, but drawbacks include excess height of the neomandible and the considerable time required to contour and adapt the upper barrel. Distraction osteogenesis is a valuable and predictable treatment option; however, its wide application is limited by complexity of the surgery and the need for additional secondary surgery. To Overcome these challenges the investigators design a technique for mandibular reconstruction where free vascularized fibula flap is splitted and non-vascularized fibula graft is harvest from same leg and is placed between two splitted parts of free fibula flap to increase vertical height of fibula.