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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 155 - 155
1 May 2016
Zumbrunn T Malchau H Rubash H Muratoglu O Varadarajan K
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INTRODUCTION. In native knees the anterior cruciate ligament (ACL) plays a major role in joint stability and kinematics. Sacrificing the ACL in contemporary total knee arthroplasty (TKA) is known to cause abnormal knee motion, and reduced function. Hence, there is growing interest in the development of ACL retaining TKA implants. Accommodation of ACL insertion around the tibial eminence is a challenge with these designs. Therefore, a reproducible and practical test setup is necessary to characterize the strength of the ACL/bone construct in ACL retaining implants. Seminal work showed importance of loading the ACL along its anatomical orientation. However, prior setups designed for this purpose are complex and difficult to incorporate into a standardized test for wide adoption. The goal of this study was to develop a standardized and anatomically relevant test setup for repeatable strength assessment of ACL construct using basic force-displacement testing equipment. METHODS. Cadaver knees were positioned with the ACL oriented along the loading axis and being the only connection between femur and tibia. 15° knee flexion was selected based on highest ACL tensions reported in literature. Therefore, the fixtures were adjusted accordingly to retain 15° knee flexion when the ACL was tensioned. The test protocol included 10 cycles of preconditioning between 6N and 60N at 1mm/s, followed by continuous distraction at 1mm/s until failure (Fig. 1). Eleven cadaveric knees (4 male, 7 female; 70.9 yrs +/−13.9 yrs) were tested using this setup to characterize a baseline ACL pullout strength (peak load to failure) in native knees. RESULTS. The average ACL pullout strength was 935.6N +/−327.5N with the extremes ranging from a minimum of 346N to a maximum of 1425N. There were five failure modes observed: [1] ACL avulsion from the femur with bony attachment (one knee), [2] ACL pull-off from the femur w/o bony attachment (two knees), [3] ACL tear (three knees), [4] ACL pull-off from the tibia w/o bony attachment (one knee), [5] ACL avulsion from the tibia with bony attachment (three knees). One knee showed a combined failure mode of 2 & 4, meaning part of the ACL was pulled off the femur and part pulled off the tibia. CONCLUSION. There was a large variation in failure load between specimens. The knee with the minimum failure load had severe arthritis, osteophytes and signs of ACL deficiency. The average failure load (935.6N +/−327.5N) is in line with those published in literature for a comparable age group. This indicates that failure loads and modes obtained with more complex setups could be reproduced by using standard uniaxial load frames and simple fixtures. The failure modes in our experiment were evenly spread between mid-substance, and insertions (either femur or tibia). This test could be used as a standardized method to investigate the strength of the ACL complex following procedures such as ACL reconstruction, partial- and total knee arthroplasty. In particular, this setup provides a reliable mechanism for evaluation of the ACL-bone construct in bi-cruciate retaining (BCR) TKA, which is likely required for regulatory pathways


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 117 - 117
1 Jul 2020
Fletcher J Neumann V Wenzel L Richards G Gueorguiev B Gill H Whitehouse M Preatoni E
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Nearly a quarter of screws cause damage during insertion by stripping the bone, reducing pullout strength by over 80%. Studies assessing surgically achieved tightness have predominately shown that variations between individual surgeons can lead to underpowered investigations. Further to the variables that have been previously explored, several basic aspects related to tightening screws have not been evaluated with regards to how they affect screw insertion. This study aims to identify the achieved tightness for several variables, firstly to better understand factors related to achieving optimal intraoperative screw purchase and secondly to establish improved methodologies for future studies. Two torque screwdrivers were used consecutively by two orthopaedic surgeons to insert 60 cortical, non-locking, stainless-steel screws of 3.5 mm diameter through a 3.5 mm plate, into custom-made 4 mm thick 20 PCF sheets of Sawbone, mounted on a custom-made jig. Screws were inserted to optimal tightness subjectively chosen by each surgeon. The jig was attached to a bench for vertical screw insertion, before a further 60 screws were inserted using the first torque screwdriver with the jig mounted vertically, enabling horizontal screw insertion. Following the decision to use the first screwdriver to insert the remaining screws in the vertical position for the other variables, the following test parameters were assessed with 60 screws inserted per surgeon: without gloves, double surgical gloves, single surgical gloves, non-sterile nitrile gloves and, with and then without augmented feedback (using digitally displayed real-time achieved torque). For all tests, except when augmented feedback was used, the surgeon was blinded to the insertion torque. Once the stopping torque was reached, screws were tightened until the stripping torque was found, this being used to calculate tightness (stopping/stripping torque ratio). Screws were recorded to have stripped the material if the stopping torque was greater than the stripping torque. Following tests of normality, Mann-Whitney-U comparisons were performed between and combining both surgeons for each variable, with Bonferroni corrections for multiple comparisons. There was no significant (p=0.29) difference in the achieved tightness between different torque screw drivers nor different jig positions (p=0.53). The use of any gloves led to significant (p < 0 .001) increases in achieved tightness compared to not using gloves for one surgeon but made no difference for the other (p=0.38–0.74). Using augmented feedback was found to virtually eliminate stripping. For one surgeon average tightness increased significantly (p < 0 .001) when torque values were displayed from 55 to 75%, whilst for the other, this was associated with significantly decreases (p < 0 .001), 72 to 57%, both surgeons returned to their pre-augmentation tightness when it was removed. Individual techniques make a considerable difference to the impact from some variables involved when inserting screws. However, the orientation of screws insertion and the type of screwdriver did not affect achieved screw tightness. Using visual feedback reduces rates of stripping and investigating ways to incorporate this into clinical use are recommended. Further work is underway into the effect of other variables such as bone density and cortical thickness


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 18 - 18
1 Feb 2020
Valiadis J
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Introduction. From 2004 to 2015, elective lumbar fusions increased by 62% in the US. The largest increases were for among age 65 or older (139% in volume) and scoliosis (187%) [1]. Age is a well known factor of osteoporosis. The load-sharing may exceed the pedicular screws constructs in aging spine and lead to non-union and re-do. Surgical options may increase the screw purchase (e.g.: augmentation, extensions) at supplementary risks. Pedicular screw are known to cause vascular, nerve root or cord injuries. Facing these pitfalls, the surgeon's experience and rule of thumbs are the most deciding factors for the surgical planning. The aim of this study is to assess the accuracy of a patient specific tool, designed to plan a safe pedicular trajectory and to provide an intraoperative screw pullout strength estimate. Materials and Methods. Clinical QCT were taken for nine cadaveric spines (82 y. [61; 87], 6 females, 3 males). The experimental maximum axial pullout resistance (FMax) of twenty-seven pedicular screws inserted (nine T12, nine L4 and nine L5) was obtained as described in a previous study [2]. A custom 3D-WYSIWYG software simulated a medio-lateral surgical insertion technique in the QCTs coordinates reference, respecting the cortical walls. Repeatable density, morphometric and hardware parameters were recorded for each vertebrae. A statistical model was built to match predictive and experimental data. Preliminary results. Experimental FMax(N) were [104;953] (359 ±223). A further displacement of 1,81mm ±0,35 halved the experimental FMax. Predictive FMax(N) were [142;862] (359 ±220). A high positive correlation between experimental and predictive FMax was revealed (Pearson, ρ = 0.93, R2 = 0.87, p < .001, figure 1). Absolute differences ranged between 3N and 177N. Discussion. A high screw purchase in primary fixation is paramount to achieve spine surgical procedures (e.g.: kyphosis, scoliosis) and postoperative stability for vertebrae fusion. High losses of screw purchase by bone plastic deformation, begin with tiny pullouts. Theses unwanted intraoperative millimetric over-displacements are hard to avoid when monitoring at the same time tens of screws surrounded by bleedings. This advocates for including predictive FMax for each implantable pedicular screw in the surgical planning decision making process to prevent failures and assess risks. For the first time, this study presents an experimentally validated statistical model for FMax prediction with a safe trajectory definition tool, including patients’ vertebrae and hardware properties and referring to the patient's clinical 3D quantitative imagery. The model was able to differentiate between bone quality and vertebrae variations. More extensive model validation is currently ongoing to interface with robotics & navigation systems and to produce meshes for 3D printing of sterilizable insertion guides