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Keywords = direct skeletal fixation

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34 pages, 2140 KB  
Review
Mechanical Design Maturity and Validation Pathways of Patient-Specific Subperiosteal Implants for Oral and Maxillofacial Rehabilitation: A Scoping Review
by Luigi Angelo Vaira, Hareem Qadeer, Andrea Biglio, Jerome R. Lechien, Fabio Maglitto, Giuseppe Consorti, Stefania Troise, Giulio Cirignaco, Giovanni Salzano, Valentino Vellone, Łukasz Woźniak, Marco Roy and Giacomo De Riu
Appl. Sci. 2026, 16(15), 7721; https://doi.org/10.3390/app16157721 - 3 Aug 2026
Viewed by 258
Abstract
Contemporary patient-specific subperiosteal implants (SPIs) have re-emerged as digitally planned, additively manufactured solutions for oral and maxillofacial rehabilitation when conventional endosseous implants are limited by severe atrophy, anatomical constraints, or reconstructive defects. Unlike conventional implants, SPIs behave as fixation-based skeletal frameworks whose performance [...] Read more.
Contemporary patient-specific subperiosteal implants (SPIs) have re-emerged as digitally planned, additively manufactured solutions for oral and maxillofacial rehabilitation when conventional endosseous implants are limited by severe atrophy, anatomical constraints, or reconstructive defects. Unlike conventional implants, SPIs behave as fixation-based skeletal frameworks whose performance depends on passive fit, screw fixation, anchorage, framework architecture, material properties, manufacturing accuracy, and prosthetic load transfer. This scoping review evaluated the maturity of mechanical design and validation evidence for contemporary SPIs. Following a predefined internal protocol and PRISMA-ScR, MEDLINE/PubMed, Scopus, Web of Science, Embase, and the Cochrane Library were searched from inception to 13 June 2026. Reference-list screening and citation tracking supplemented the electronic search. Two reviewers independently screened records against predefined eligibility criteria. Data were charted using a predefined extraction form and synthesized descriptively by evidence type, engineering domain, validation stage, and translational status. No meta-analysis was undertaken because of methodological heterogeneity, and no formal risk-of-bias grading was applied. Across 65 included records, the evidence was dominated by descriptive technical studies and comparative computational analyses, whereas direct mechanical testing, fatigue assessment, manufacturing verification, and clinical correlation were limited. Finite element analysis was useful for comparing design alternatives and identifying stress concentrations, but models were heterogeneous and often insufficiently validated. Design modifications generally redistributed stress across the implant–prosthesis–bone system rather than reducing it globally. Titanium and Ti6Al4V were the most established framework materials, whereas polymeric, ceramic, and scaffold-assisted strategies remained preliminary. The principal contribution of this review is a cross-domain appraisal of progression from anatomical feasibility and comparative modeling to manufacturing verification, experimental testing, and clinical validation. An evidence map, minimum reporting checklist, and integrated validation pathway are provided to support reproducible device development. Full article
(This article belongs to the Special Issue Mechanical Design and Modeling for Medical Devices and Simulators)
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15 pages, 11419 KB  
Article
Reconstructive Strategies in Post-Traumatic Osteomyelitis of the Lower Limb: A Case Series and Surgical Algorithm Analysis
by Marta Jagosz, Piotr Węgrzyn, Michał Chęciński, Maja Smorąg, Jędrzej Króliński, Szymon Manasterski, Patryk Ostrowski and Ahmed Elsaftawy
J. Clin. Med. 2025, 14(19), 6746; https://doi.org/10.3390/jcm14196746 - 24 Sep 2025
Cited by 4 | Viewed by 4216
Abstract
Background: Post-traumatic osteomyelitis (PTO) of the lower extremity is among the most demanding problems in orthoplastic reconstructive surgery. It typically follows open fractures, failed osteosynthesis, or implant infection. Effective management requires coordinated infection control, stable skeletal fixation, and timely vascularized soft-tissue coverage. Methods: [...] Read more.
Background: Post-traumatic osteomyelitis (PTO) of the lower extremity is among the most demanding problems in orthoplastic reconstructive surgery. It typically follows open fractures, failed osteosynthesis, or implant infection. Effective management requires coordinated infection control, stable skeletal fixation, and timely vascularized soft-tissue coverage. Methods: We conducted a retrospective case series of 20 consecutive patients with PTO of the lower limb treated between 2021 and 2024 at a tertiary orthoplastic center. All patients underwent radical debridement, culture-directed intravenous antibiotic administration, and soft-tissue reconstruction using local muscle, fasciocutaneous, or free flaps; vascularized bone flaps were used to select nonunion cases. The primary outcomes were flap survival, complications, infection resolution, and limb salvage. Exploratory analyses included descriptive subgroup summaries by flap category. Results: Among 20 patients (15 men, 5 women; mean age 53.6 years), reconstructions included reverse/pedicled sural flaps (n = 9), hemisoleus muscle flaps (n = 7), medial gastrocnemius muscle flaps (n = 2), peroneus brevis muscle flaps (n = 2), and free flaps (n = 6), which comprised anterolateral thigh (ALT), medial femoral condyle (MFC) osteoperiosteal, deep circumflex iliac artery (DCIA) osteocutaneous, and radial forearm free flaps (RFFFs). Single-flap reconstructions were performed in 13 cases, whereas multistage/multiflap strategies were used in 7. Overall flap survival was 90%. Major flap complications comprised partial necrosis in two reverse sural flaps and one complete loss of a reverse sural flap; two patients had minor wound dehiscence. Infection resolved in 18/20 patients (90%; 95% CI ≈ 0.70–0.97). One patient requested below-knee amputation due to persistent nonunion associated with a pathological fracture. At a mean 10-month follow-up, all limb-salvaged patients were ambulatory. Conclusions: Effective reconstruction of PTO is improved by using a patient-specific algorithm that considers the defect location, vascular status, and host comorbidities. Local muscle and fasciocutaneous flaps remain dependable for most defects, with free or vascularized bone flaps reserved for composite or recalcitrant cases. Early referral to high-volume centers, radical debridement, and orthoplastic collaboration are critical for optimizing limb salvage. Our findings should be interpreted in light of the study’s retrospective design and small sample size. Full article
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19 pages, 4573 KB  
Article
A Real Time Delphi Study on the Challenges and Adverse Events to Percutaneous Osseointegrated Implant Integration and Long-Term Fixation in Limb Amputation
by Kirstin Ahmed and Max Ortiz-Catalan
Prosthesis 2024, 6(5), 1262-1280; https://doi.org/10.3390/prosthesis6050091 - 21 Oct 2024
Cited by 3 | Viewed by 4209
Abstract
Percutaneous Osseointegrated Implants (POI) affix artificial limbs to the body after amputation. Several adverse events challenge mainstream uptake of this technology. This study aims to achieve a consensus regarding “the challenges and adverse events to POI integration and long-term fixation in limb [...] Read more.
Percutaneous Osseointegrated Implants (POI) affix artificial limbs to the body after amputation. Several adverse events challenge mainstream uptake of this technology. This study aims to achieve a consensus regarding “the challenges and adverse events to POI integration and long-term fixation in limb amputation”. We sought a panel of clinical experts divided by profession into surgical, clinical, or clinical academic categories. We used a real time eDelphi method to develop consensus on both the challenges and adverse event items, enabling anonymity, iteration, controlled feedback, and statistical aggregation of group responses. The full panel agreed that the most impactful items are amongst 10 key challenges and eight adverse events. Panellists were in consensus regarding the five most impactful challenges, which were, in decreasing order: patient selection, absence of a multidisciplinary team, design of the implant, soft tissue stability and an experienced surgical team. Panellists considered the five most impactful adverse events, in decreasing order, to be the following: no biological fixation, deep infection, aseptic loosening, no mechanical fixation, and implant breakage. Consensus was obtained on implant breakage and deep infection items. The proportion of consensus from the whole panel across all items was in line with the literature, and we observed an improvement in consensus once the panel was stratified based on job, expertise and implant system. Full article
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18 pages, 4010 KB  
Article
Intramedullary Skeletal Distraction Robot: Novel Design and Optimization of Implantable Lengthening Nail
by ShiKeat Lee, Zhenguo Nie, Handing Xu, Kai Hu, Hanwei Lin, Fugui Xie and Xin-jun Liu
Machines 2022, 10(10), 843; https://doi.org/10.3390/machines10100843 - 23 Sep 2022
Viewed by 3944
Abstract
Leg Length Discrepancy (LLD) is a critical problem which not only impacts the quality of life but also causes other physical ailments such as limping and severe back pain. Most people had a non-negligible difference in the length of their two legs, and [...] Read more.
Leg Length Discrepancy (LLD) is a critical problem which not only impacts the quality of life but also causes other physical ailments such as limping and severe back pain. Most people had a non-negligible difference in the length of their two legs, and 0.1% of the population with differences of 20 mm or more are diagnosed as a difference in limb length. The Ilizarov external fixator is commonly used in treating LLD as conventional therapeutic equipment, but often causes serious complications that cannot be prevented. Therefore, intramedullary leg-lengthening treatment has become popular in distraction osteogenesis to eliminate extracorporeal surgery. This paper presents a study on the design and optimization of a novel electromagnetic-driven Intramedullary Skeletal Distraction Robot (ISDR) with robust mechanical stiffness and surplus electromagnetic driving force. Compared with PRECICE, the split structure of ISDR eases the optimal design and manufacturing difficulties to strengthen mechanical stiffness, and the electromagnetic configuration allows improving the distraction force by adjusting the Permanent Magnet Brushless Direct Current (PMBLDC) motor parameters. ISDR, which is implanted in the medullary cavity, has the Von-Mises stress of 952.15 MPa, and the first mode of natural frequency is 28.823 Hz indicating that it can withstand the load during the walking gait phases. On the other hand, the ISDR distraction force encounters resistance from muscle fibers, and an average driving torque of 9 Nmm ensures its distraction. Based on the results, ISDR is proven secure and reliable during and after leg-lengthening treatment, which can significantly reduce lifestyle disruption and medical complications. Full article
(This article belongs to the Topic Advanced Electrical Machines and Drives Technologies)
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10 pages, 5757 KB  
Case Report
Limb Salvage after Lower-Leg Fracture and Popliteal Artery Transection—The Role of Vessel-First Strategy and Bone Fixation Using the Ilizarov External Fixator Device: A Case Report
by Vincenzo Giordano, Felipe Serrão Souza, William Dias Belangero and Robinson Esteves Pires
Medicina 2021, 57(11), 1220; https://doi.org/10.3390/medicina57111220 - 9 Nov 2021
Cited by 3 | Viewed by 7239
Abstract
Open traumatic lesion of the popliteal artery is relatively rare. Ischemia time longer than 6 h and severity of limb ischemia have been shown to be associated with an increased risk of limb loss. Severe local infection is critical in the presence of [...] Read more.
Open traumatic lesion of the popliteal artery is relatively rare. Ischemia time longer than 6 h and severity of limb ischemia have been shown to be associated with an increased risk of limb loss. Severe local infection is critical in the presence of major soft tissue trauma or open fractures. We report the case of a young female who suffered a traumatic transection of the popliteal artery associated with an open fracture of the distal tibia and fibula managed by direct vessel reconstruction with an end-to-end repair and skeletal stabilization initially with half-pin external fixation, then replaced by an Ilizarov circular frame. The patient had a very satisfactory outcome, but the fracture healed malunited, later corrected by open reduction and internal fixation with lag-screwing and a neutralization plate. Full article
(This article belongs to the Special Issue Malunion of Fractures of the Lower Extremity)
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