Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Non-Union Treatment in the Foot, Ankle, and Lower Leg: A Multicenter Retrospective Study Comparing Conventional Treatment with the Human Allogeneic Cortical Bone Screw (Shark Screw®)

Version 1 : Received: 1 March 2024 / Approved: 4 March 2024 / Online: 4 March 2024 (14:04:54 CET)

A peer-reviewed article of this Preprint also exists.

Labmayr, V.; Huber, E.; Wenzel-Schwarz, F.; Holweg, P.; Ornig, M.; Jakob, G.; Palle, W.; Borchert, G.H.; Pastl, K. Non-Union Treatment in the Foot, Ankle, and Lower Leg: A Multicenter Retrospective Study Comparing Conventional Treatment with the Human Allogeneic Cortical Bone Screw (Shark Screw®). J. Pers. Med. 2024, 14, 352. Labmayr, V.; Huber, E.; Wenzel-Schwarz, F.; Holweg, P.; Ornig, M.; Jakob, G.; Palle, W.; Borchert, G.H.; Pastl, K. Non-Union Treatment in the Foot, Ankle, and Lower Leg: A Multicenter Retrospective Study Comparing Conventional Treatment with the Human Allogeneic Cortical Bone Screw (Shark Screw®). J. Pers. Med. 2024, 14, 352.

Abstract

Addressing non-unions involves stabilizing the affected area through osteosynthesis and improving bone biology using bone grafts. However, there is no consensus on the optimal treatment method. This study aims to compare outcomes of non-union revision using conventional treatment methods (metal hardware ± graft) versus osteosynthesis with the human, allogeneic cortical bone screw (Shark Screw®). Thirty-four patients underwent conventional treatment, while 28 cases received Shark Screws®. Patient demographics, bone healing, time to bone healing, and complications were assessed. Results revealed a healing rate of 96.4% for the Shark Screw® group, compared to 82.3% for the conventionally treated group. The Shark Screw® group exhibited a tendency for faster bone healing (9.4±3.2 vs. 12.9±8.5 weeks, p=0.05061). Hardware irritations led to six metal removals in the conventional group versus two in the Shark Screw® group. The Shark Screw® emerges as a promising option for personalized non-union treatment in the foot, ankle, and select lower leg cases, facilitating effective osteosynthesis and grafting within a single construct, promoting high union rates, low complications, and a rapid healing process.

Keywords

bone healing; non-union; human allogeneic cortical bone screw; Shark Screw®; allograft; pseudarthrosis; foot and ankle; time to union; delayed union; return to work; hardware removal; health care costs

Subject

Medicine and Pharmacology, Orthopedics and Sports Medicine

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