Abstract:Objective To explore the feasibility and accuracy of a novel 3D-Printed Patient-Specific Instrument(PSI) based on “H”Point for medial opening-wedge high tibial osteotomy(OWHTO) in a prospective cadaver study.Methods Twenty-four entire fresh-frozen lower limbs from twelve cadavers were collected,including 5 males and 7 females and aged 53~72 years old with mean age of (60.92±5.92).All lower limbs were randomly divided into two groups:(1)PSI group (n=14) treated with 3D virtual preoperative planning and a novel 3D-Printed PSI;(2)control group (n=10) with 2D planning and standard technique.Utilizing medical software and three-dimensional design software,3D models were reversely reconstructed for preoperative surgical planning,guide plate design,and simulated osteotomy.Both the preoperative design and the actual operation,“H” point bony bulge was used as the positioning mark of the PSI guide.All specimens recorded the parameters including preoperative mechanicalmedial proximal tibial angle(mMPTA),pre-and postoperative mechanical femorotibial angle(mFTA),pre-and postoperative posterior tibial slope(PTS),the number of intraoperative fluoroscopy and operation time.Results There was no statistical difference between the two groups in mFTA (P=0.553) and PTS (P=0.813) after operation.But the absolutecorrection error of mFTA and PTS were significantly smaller in the PSI group.The effective rate of mFTA in the PSI group was more concentrated with absolute correction error within 1° for 85.7% compared to 60% in the control group.The effective rate of PTS in the PSI group was more concentrated with absolute correction error within 1° and within 2° for 57.1% and 92.9%,compared to 20% and 50% in the control group.The total operation time,positioning osteotomy time,distraction correction time and fluoroscopy dose in the PSI group were significantly less than those in the control group.Conclusion The novel 3D-Printed PSI based on "H"point is feasibility and accuracy with advantages in terms ofoperation time and radiation exposure for HTO.
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