Chorny V. Osteosynthesis with magnesium-based alloy implants.

Українська версія

Thesis for the degree of Doctor of Science (DSc)

State registration number

0521U100838

Applicant for

Specialization

  • 14.01.21 - Травматологія та ортопедія

09-04-2021

Specialized Academic Board

Д 64.607.01

SI "Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine"

Essay

Object: bioresorbable magnesium-based alloys; the effect of magnesium alloys on the body; bone regeneration under conditions of use for osteosynthesis of implants based on magnesium alloys. Aim: to create a scientific and theoretical basis for the medical use of magnesium-based alloys, to develop new bioresorbable implants for osteosynthesis and to conduct their clinical trial. Methods: clinical; metallographic analysis (light, electron scanning microscopy, fractographic and phase analysis); mechanical; experimental studies of bone regeneration; biochemical; bacteriological; statistical. For the first time, experimental data on the dynamics of resorption of magnesium-based alloys ML-5, ML-10 in physiological solutions were obtained, and it was found that within 3 months ML-5 samples lose 43.5 % of their strength, and ML-10 - 46.8 %. According to the results of the study, the technological development of a new, silver-modified magnesium alloy MS-10 (TУ У 24.4-14307794-270: 2018), which has a longer resorption period (18.3 %) than ML-10. For the first time, according to the morphological study, it was found that the biodegradation products of implants from a modified alloy based on magnesium MS-10 do not affect the regeneration of bone tissue of laboratory rabbits. Biochemical studies have shown that the bioresorption products of the developed alloy MS-10 do not affect the organism of laboratory rats - no signs of intoxication, and do not lead to changes in behavior, do not have a neurotoxic effect. It was first researched bactericidal effect of bioresorption products of the developed MS-10 alloy on cultures reference test strains of S. aureus, E. coli and P. aeruginosa, clinical strains of the family Enterobacteriaceae, non-fermenting gram-negative microorganisms A. baumannii and P. aeruginosa, staphylococci and enterococci. Experimental clinical trials have shown that the use of maleolar screw from the developed magnesium-based alloy MS-10 does not affect the time of regeneration of the medial bone fractures and does not cause complications of the wound process. Based on the data obtained in the experiment, devices for osteosynthesis were developed: maleolar screws, interference screws and anchor screws. All devices have received the production certificate. Tools for osteosynthesis with implants made of MS-10 alloy have been developed and put into the clinical practice. The indications for the use of structures in clinics have been clarified. Clinical testing of structures made from the developed magnesium-based alloy (MS-10) revealed high efficacy in bone fractures due to positive effects on osteoraparation, lack of toxicological reactions, high biocompatibility. The advantage of the designed structures is their bioresorption with synchronous replacement with bone tissue. A package of documents has been prepared to obtain a decision on the possibility of clinical use of metal structures for osteosynthesis. The results of the study were introduced into clinical practice in the departments of traumatology and orthopedics of the LLC "Motor Sich Clinic", Communal non-profit enterprise "City Hospital of Emergency and Ambulance Medicine" of the Zaporizhzhia City Council, Communal non-profit enterprise "Zaporizhzhia Regional Clinical Hospital" of the Zaporizhzhia Regional Council. Traumatology and Orthopaedics.

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