Modular Osteotomy System for Tibial Slope Correction
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Solution Overview
Problem
Current open wedge osteotomy techniques are challenging due to lack of precision, high surgical learning curve, frequent use of fluoroscopy, and complications such as nonunion and loss of correction, primarily because they rely on hand-guided methods and static internal fixation plates that stress-shield the osteotomy site.
Innovation Solution
An instrument-guided, modular open wedge osteotomy system comprising a positioning guide, cutting guide, mechanical jack, and multi-part implant that allows precise bone resection, accurate correction of the anterior-to-posterior tibial slope, and minimizes the need for fluoroscopy, using a mechanical jack to open the osteotomy void and a multi-part implant to support the osteotomy site with customizable components for optimal bone growth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If hand-guided guidewires and bone resecting tools are used, then the surgeon can perform the osteotomy procedure, but precision and reproducibility are compromised leading to surgical errors
Solution Approach 1:
The surgical system is divided into multiple specialized components: positioning guide for establishing alignment, cutting guide for precise bone resection, mechanical jack for controlled wedge opening, and multi-part implant for stabilization. Each component performs a specific function with high precision, eliminating the need for the surgeon to master complex hand-guided techniques while maintaining surgical simplicity through modular assembly
Solution Approach 2:
The positioning guide and cutting guide act as intermediaries between the surgeon's intent and the actual bone resection. These guides translate preoperative planning into precise intraoperative execution by providing physical constraints and reference surfaces, thereby achieving high measurement precision without requiring complex surgical skills
2Strength
If static internal fixation plates are used to support the osteotomy site, then fixation stability is achieved, but stress-shielding occurs leading to nonunion and loss of correction
Solution Approach 1:
The fixation system transitions from static rigid plates to a dynamic progressive loading system. The mechanical jack allows controlled opening of the wedge to achieve precise correction, and the multi-part implant with gradual load transfer enables progressive bone healing. This dynamic approach maintains fixation stability while avoiding stress-shielding by allowing controlled micromotion and load transfer that stimulates bone union
Solution Approach 2:
The system changes the mechanical parameters at the osteotomy site from complete rigidity to controlled flexibility. The multi-part implant design allows for gradual load transfer and progressive stabilization, adjusting the mechanical environment to promote bone healing while maintaining correction stability
3Measurement precision
If frequent fluoroscopy is used to monitor the procedure, then surgical accuracy can be verified, but surgical time increases and radiation exposure occurs
Solution Approach 1:
All alignment and positioning decisions are made during preoperative planning using patient-specific imaging and computational tools. The positioning guide and cutting guide are designed based on preoperative measurements, allowing the surgeon to execute the procedure without frequent intraoperative fluoroscopy. This preliminary action eliminates the need for repeated verification imaging during surgery
4Ease of operation
If hand-guided osteotomes are used to open the wedge, then the procedure can be performed, but surgical errors and complications increase
Solution Approach 1:
The manual mechanical system of hand-guided osteotomes is replaced with a controlled mechanical jack system. The jack provides precise, incremental opening of the osteotomy wedge with controlled force application, eliminating the variability and error potential of hand-guided techniques while maintaining ease of operation through a simple cranking mechanism
Data Source
AI summary
A system and method for performing an opening wedge osteotomy in a tibia, the system and method comprising (i) a positioning guide configured for aligning a portion of the positioning guide with a joint line of the tibia and for fixing the positioning guide to the tibia; (ii) a cutting guide configured to direct a cutting blade into the tibia so as to form a bone cut therein; (iii) a mechanical jack configured for placement into the bone cut in the tibia so as to distract the tibia at the bone cut; and (iv) a multi-part implant for supporting the open wedge osteotomy in the tibia, with a first component for disposition in a posterior portion of the open wedge osteotomy, a second component for disposition in an anterior portion of the open wedge osteotomy, and a connection device for selectively connecting the components to one another.