A New Augmentation Method for Improved Screw Fixation in Fragile Bone

Deepak Bushan Raina, Vetra Markevičiūtė, Mindaugas Stravinskas, Joeri Kok, Ida Jacobson, Yang Liu, Erdem Aras Sezgin, Hanna Isaksson, Stefan Zwingenberger, Magnus Tägil, Šarūnas Tarasevičius, Lars Lidgren, Deepak Bushan Raina, Vetra Markevičiūtė, Mindaugas Stravinskas, Joeri Kok, Ida Jacobson, Yang Liu, Erdem Aras Sezgin, Hanna Isaksson, Stefan Zwingenberger, Magnus Tägil, Šarūnas Tarasevičius, Lars Lidgren

Abstract

Pertrochanteric fractures (TF) due to osteoporosis constitute nearly half of all proximal femur fractures. TFs are treated with a surgical approach and fracture fixation is achieved using metallic fixation devices. Poor quality cancellous bone in osteoporotic patients makes anchorage of a fixation device challenging, which can lead to failure of the fracture fixation. Methods to reinforce the bone-implant interface using bone cement (PMMA) and other calcium phosphate cements in TFs have been described earlier but a clear evidence on the advantage of using such biomaterials for augmentation is weak. Furthermore, there is no standardized technique for delivering these biomaterials at the bone-implant interface. In this study, we firstly describe a method to deliver a calcium sulphate/hydroxyapatite (CaS/HA) based biomaterial for the augmentation of a lag-screw commonly used for TF fixation. We then used an osteoporotic Sawbones model to study the consequence of CaS/HA augmentation on the immediate mechanical anchorage of the lag-screw to osteoporotic bone. Finally, as a proof-of-concept, the method of delivering the CaS/HA biomaterial at the bone-implant interface as well as spreading of the CaS/HA material at this interface was tested in patients undergoing treatment for TF as well as in donated femoral heads. The mechanical testing results indicated that the CaS/HA based biomaterial increased the peak extraction force of the lag-screw by 4 times compared with un-augmented lag-screws and the results were at par with PMMA. The X-ray images from the patient series showed that it was possible to inject the CaS/HA material at the bone-implant interface without applying additional pressure and the CaS/HA material spreading was observed at the interface of the lag-screw threads and the bone. Finally, the spreading of the CaS/HA material was also verified on donated femoral heads and micro-CT imaging indicated that the entire length of the lag-screw threads was covered with the CaS/HA biomaterial. In conclusion, we present a novel method for augmenting a lag-screw in TFs, which could potentially reduce the risk of fracture fixation failure and reoperation in fragile osteoporotic patients.

Keywords: biomaterial; hip fracture; implant augmentation; implant integration; osteoporosis.

Conflict of interest statement

LL is a board member and founder of Bonesupport, AB, Sweden and board member of OrthoCell Ltd. Australia. LL, MT, and DBR hold shares in Moroxite AB, Sweden. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Raina, Markevičiūtė, Stravinskas, Kok, Jacobson, Liu, Sezgin, Isaksson, Zwingenberger, Tägil, Tarasevičius and Lidgren.

Figures

FIGURE 1
FIGURE 1
CaS/HA biomaterial-based augmentation of a lag-screw in an osteoporotic Sawbones model. An overview of experimental steps is provided in the radiological time-lapse images starting from (i) the partial placement of the lag-screw followed by (ii) insertion of the injection device through the lag-screw (ii). (iii) CaS/HA biomaterial filled in the pre-drilled canal and (iv) the final position of the lag-screw surrounded by the CaS/HA material. Dashed black lines in (i) and (ii) indicate the approximate position of the pre-drilled region. Scale bar = approximately 1.3 cm.
FIGURE 2
FIGURE 2
A schematic indicating the current praxis used for the surgical management of pertrochanteric fractures (top) and the proposed solution of augmenting the lag-screw with a CaS/HA biomaterial to reduce fracture fixation device failure (bottom).
FIGURE 3
FIGURE 3
A surgical method of delivering a CaS/HA biomaterial through a cannulated lag-screw in a patient undergoing treatment for pertrochanteric fracture. (i) X-ray showing a pertrochanteric fracture. (ii) A photograph of the injection cannula being connected to a regular injection syringe containing the CaS/HA biomaterial. (iii) Placement of the titanium cannula at the most distal end of the pre-drilled canal via the cannulated lag-screw visualized radiographically. (iv) Radiographic image of the CaS/HA biomaterial being injected into the pre-drilled canal in-front of the lag-screw. (v) Radiograph of the final position of the lag-screw with the biomaterial around. Scale bar in panels iii-v is ∼1.3 cm.
FIGURE 4
FIGURE 4
Mechanical effects of CaS/HA augmentation on lag-screw anchorage in Sawbones (Top) Shows photographs of the Sawbones block and the lag-screw after the pull-out test. Notice the spreading of the CaS/HA material in the pre-drilled hole and the presence of both CaS/HA and PMMA biomaterial-Sawbones composite on the lag-screws after pull-out testing (Bottom) Scatter plots showing mean peak force to pull-out the screw, the stiffness and work required until the failure of the screws in the Sawbones model. * Indicates p < 0.05, ** indicates p < 0.01 and **** indicates p < 0.0001. ns indicates not significant. Scale bar indicates 1.3 cm.
FIGURE 5
FIGURE 5
CaS/HA spreading around the lag-screw and bone interface in cadaver femoral head as observed by micro-CT and a digital photograph taken after removal of the lag screw. Scale bar indicates ∼0.5 cm.
FIGURE 6
FIGURE 6
CaS/HA spreading around the lag-screw in patients undergoing pertrochanteric fracture fixation using a sliding lag-screw and a femoral plate. Arrows indicate the radio dense CaS/HA material around the lag-screw-bone interface. Scale bar indicates ∼1.3 cm.

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