Episode 5: Custom Implants, Built to Fit – Unstandardized: Built for One скачать в хорошем качестве

Episode 5: Custom Implants, Built to Fit – Unstandardized: Built for One

Custom implants are no longer just salvage solutions for rare cases. From the early modular stems of the 1960s to the triflange acetabular implant that transformed pelvic reconstruction, and from hospital-based design labs to modern AI-driven workflows, this episode traces the rise of personalization in orthopedics. We explore how additive manufacturing, regulatory clarity, and clinical data are converging to make patient-specific implants not just possible, but practical — with proven benefits in function, complications, recovery, and cost. The future of implants isn’t about choosing the best tray. It’s about designing the only one that fits. Timestamps 00:00 – The need for personalization in orthopedics 02:24 – Rethinking implant design philosophy 05:42 – The evolution of modularity 08:37 – Custom implants born from oncology and trauma 10:05 – The triflange revolution in acetabular reconstruction 12:30 – In-house design at HSS and hospital-based workflows 14:55 – Conformis: custom implants for everyone 17:19 – Additive manufacturing and AI in design 20:38 – Regulatory clarity for patient-specific devices 23:07 – Data proving personalization works 28:25 – The cost-effectiveness of custom implants 31:47 – Barriers: trials, reimbursement, and training 34:00 – Beyond metal: BioRSA and biologics Modularity and the Rise of Configurability The Sivash stem (1956, Soviet Union) was one of the first modular hips, introducing a titanium cementless stem-sleeve design that laid the foundation for modern modularity. The S-ROM stem, derived from Sivash’s work in the 1980s, expanded modular sleeve-stem technology and has demonstrated +90% survivorship at 10–15 years in complex and revision cases. (https://www.upoj.org/wp-content/uploa..., https://journals.healio.com/doi/abs/1..., https://journals.plos.org/plosone/art... ) Oncology as the Birthplace of Custom Implants By the late 1970s–1980s, limb salvage replaced amputation in many malignant bone tumors. Bulk allografts were widely used but carried high rates of fracture, resorption, and infection. Modular tumor prostheses and eventually custom megaprostheses improved stability, function, and survival. Early work in India, the UK, and the US established leaders in CAD-CAM custom design. (https://journals.lww.com/jaaos/fullte..., https://ascopubs.org/doi/abs/10.1200/..., https://www.thieme-connect.com/produc..., https://journals.sagepub.com/doi/abs/..., https://link.springer.com/article/10...., https://link.springer.com/article/10.... ) Hospital-Based Custom Development (Stanmore & RNOH) Stanmore Implants, developed at the Royal National Orthopaedic Hospital (RNOH), pioneered modular and extendible custom endoprostheses in the 1980s, particularly for pediatric and adult oncology limb salvage. ( https://boneandjoint.org.uk/article/1... , https://link.springer.com/chapter/10.... ) Triflange Acetabular Implants Triflange acetabular components were introduced in the 1990s (Tecmedica, later Biomet) to treat Paprosky 3A/3B defects and pelvic discontinuity. CT-based planning with ilium/ischium/pubis flanges provided rigid fixation and restored hip center. Long-term studies of 241 hips show ~81–89% survivorship at 15–30 years, Harris Hip Score improvements (30 → 75), and complication rates comparable or superior to cages. ( https://link.springer.com/article/10.... , https://www.ncbi.nlm.nih.gov/pmc/arti... , https://pmc.ncbi.nlm.nih.gov/articles... , https://www.sciencedirect.com/science... , https://link.springer.com/article/10.... , https://pmc.ncbi.nlm.nih.gov/articles... , https://eor.bioscientifica.com/view/j... , https://boneandjoint.org.uk/article/1... , https://onlinelibrary.wiley.com/doi/a... ) Point-of-Care and Hospital-Based 3D Printing Hospitals like HSS, Mayo, and Cleveland Clinic pioneered point-of-care labs for anatomical models, guides, and implants, cutting prototyping costs from $500–$1000 to $30–$50 and turnaround from weeks to days. LimaCorporate’s ProMade facility at HSS became the first FDA-registered in-hospital AM site. ( https://www.hss.edu/newsroom_on-site-... , https://pubs.rsna.org/doi/10.1148/rg...., https://pubmed.ncbi.nlm.nih.gov/35988... , https://doi.org/10.1097/SCS.000000000... , https://www.mdpi.com/2306-5354/12/5/494 , https://www.sciencedirect.com/science... , https://doi.org/10.1016/j.jse.2023.04... , https://www.hss.edu/research/innovati... )