jktoКафедра травматологии и ортопедииDepartment of Traumatology and Orthopaedics2226-2016ПРОФИЛЬ — 2С10.17238/2226-2016-2024-2-19-25jkto-45Research ArticleОРИГИНАЛЬНОЕ ИССЛЕДОВАНИЕORIGINAL RESEARCHДИЗАЙН И ОБОСНОВАНИЕ ПРОСПЕКТИВНОГО РАНДОМИЗИРОВАННОГО ИССЛЕДОВАНИЯ БИОЛОГИЧЕСКОЙ АУГМЕНТАЦИИ АРТРОСКОПИЧЕСКОЙ РЕКОНСТРУКЦИИ РАЗРЫВОВ ВРАЩАТЕЛЬНОЙ МАНЖЕТЫ ПЛЕЧА КОНЦЕНТРАТОМ АСПИРАТА КОСТНОГО МОЗГА (BMAC)DESIGN AND RATIONALE OF A PROSPECTIVE RANDOMIZED TRIAL OF BIOLOGIC AUGMENTATION WITH BONE MARROW ASPIRATE CONCENTRATE (BMAC) IN ARTHROSCOPIC RECONSTRUCTION OF ROTATOR CUFF TEARВетошкинА. А.VetoshkinA. A.,

Ветошкин Александр Александрович – канд. мед. наук, доцент, врач-травматолог-ортопед, отд. травматологии и ортопедии

ул. Акад. Лебедева, д.4/2, Санкт-Петербург, 194044

Aleksandr A. Vetoshkin – PhD Med. Sci. Associate Prof., orthopedic trauma surgeon, traumatology and orthopedics department

Academica Lebedeva Str., 4/2, St. Petersburg, 194044

totoalex5@gmail.comВасильченкоН. В.VasilchenkoN. V/

Васильченко Никита Вадимович – врач травматолог-ортопед, отд. травматологии и реабилитации

ул. Староволынская, д.10, Москва, 121352

Nikita V. Vasilchenko – traumatologist-orthopedist, department of traumatology and rehabilitation, Federal state budgetary institution Clinical hospital No. 1»

Starovolynskaya Str., 10, Moscow, 121352

infosustav@ya.ruГусевС. С.GusevS. S.

Гусев Сергей Сергеевич – врач травматолог-ортопед, отд. травматологии и ортопедии

ул. Староволынская, д.10, Москва, 121352

Sergei S. Gusev – traumatologist-orthopedist, department of traumatology and orthopedics

Starovolynskaya Str., 10, Moscow, 121352

dr.sergeygusev@gmail.comУчеваткинА. А.UchevatkinA. A.

Учеваткин Андрей Алексеевич – к.м.н., заведующий Учебным центром

ул. Петровка, д.24 стр.1, Москва, 12705

Andrey A. Uchevatkin – Radiologist, Head of Educational Department

Petrovka Str., 24-1, Moscow, 127051

uchevatkin@mail.ruФГБУ Всероссийский центр экстренной и радиационной медицины им. А.М. Никифорова МЧС РоссииРоссияFederal State Public Enterprise Nikiforov’s All-Russian Center for Emergency and Radiation Medicine of the Emergencies Ministry of RussiaRussian FederationФГБУ Клиническая больница №1 Управления делами Президента РФРоссияFederal state budgetary institution Clinical hospital No. 1» (Volynskaya) of the Office of the President of the Russian FederationRussian FederationФГБУ Всероссийский центр экстренной и радиационной медицины им. А.М. Никифорова МЧС РоссииРоссияFederal state budgetary institution Clinical hospital No. 1» (Volynskaya) of the Office of the President of the Russian FederationRussian FederationГБУЗ Научно-практический клинический центр диагностики и телемедицинских технологий Департамента здравоохранения города МосквыРоссияState budgetary health care institution of the Moscow city Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies Department of Health of the City of MoscowRussian Federation202413032026021925Copyright © Ветошкин А.А., Васильченко Н.В., Гусев С.С., Учеваткин А.А., 20262026Ветошкин А.А., Васильченко Н.В., Гусев С.С., Учеваткин А.А.Vetoshkin A.A., Vasilchenko N.V., Gusev S.S., Uchevatkin A.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.jkto.moscow/jour/article/view/45

Обоснование. Распространенность разрывов вращательной манжеты плеча остается на высоком уровне в популяции, достигая 20 %, при этом тенденции к снижению данного показателя не наблюдается. Несмотря на очевидный прогресс в диагностике и хирургическом лечении достижение желаемых воспроизводимых клинических результатов не всегда возможно.Цель исследования ‒ сравнительный анализ эффективности стандартной артроскопической методики восстановления средних и больших разрывов вращательной манжеты плеча и дополненного использованием концентрата аспирата костного мозга (BMAC).Материалы и методы. Проспективное рандомизированное исследование включит пациентов с диагнозом средних и больших разрывов сухожилий вращательной манжеты плеча, подходящих под критерии исследования. Пациенты (n = 80) будут распределены (1:1) случайным образом в экспериментальную группу (артроскопический шов сухожилий вращательной манжеты совместно с интраоперационным введением BMAC) и контрольную группу (артроскопический шов сухожилий вращательной манжеты без BMAC). Наблюдение за пациентами в течение 12 месяцев на этапах и 3, 6, 12 месяцев после операции с выполнением МРТ исследования и оценкой динамики функциональных результатов по шкалам ASES, DASH, UCLA и SST.Результаты. Гипотеза исследования – артроскопическое восстановление разрывов вращательной манжеты плеча, дополненное использованием (BMAC), позволит добиться лучших показателей восстановления целостности тканей, при этом динамика снижения выраженности болевого синдрома и улучшения функции сустава будет сопоставимой.Заключение. Прогресс в результатах восстановления вращательной манжеты связан с разработкой комбинации клеточных или биологических технологий с возможностями хирургической реконструкции. Планируемое проспективное исследование позволит определить роль биологической аугментации артроскопической реконструкции повреждений.

Introduction. Rotator cuff tears are a common shoulder pathology with an increasing incidence, reaching up to 20% in the population, while currently no downward trend is observed. Although we have witnessed remarkable advances in the diagnosis and surgical treatment based on solid science and extensive clinical practice, considerable controversy remains over the optimal reproducible clinical outcomes.Purpose is to compare the effects of the arthroscopic treatment for medium to large rotator cuff tears with and without bone marrow aspirate concentrate (BMAC) augmentation.Materials and methods: The prospective randomized trial will enroll eligible patients (n = 80). Patients will be randomly assigned (1:1) to the experimental group (arthroscopic rotator cuff suture repair with BMAC application) and the control group (arthroscopic rotator cuff suture repair without BMAC application). Outcomes will be assessed at 3, 6, 12 months after surgery by magnetic resonance imaging and with respect to functional scores using the scoring systems ASES, DASH, UCLA and SST.Results: The hypothesis of the study is that the arthroscopic repair of rotator cuff tears augmented by BMAC will improve tissue integrity, while the rates of reducing pain and improving function will be comparable.Discussion: Remarkable advances in rotator cuff repair involve the combination of cell-based and biological therapies and advanced surgical approaches. The planned prospective trial will determine the role of biological augmentation in outcomes of arthroscopic rotator tears repair.

вращательная манжетааспират костного мозгаBMACартроскопия плечевого суставареконструкция манжеты ротаторовrotator cuffbone marrow aspirateBMACshoulder arthroscopyrotator cuff reconstructionReferencesMinagawa H., Yamamoto N., Abe H., Fukuda M., Seki N., Kikuchi K., Kijima H., Itoi E. Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: from mass-screening in one village. J Orthop. 2013;10(1):8–12. doi: 10.1016/j.jor.2013.01.008.Minagawa H., Yamamoto N., Abe H., Fukuda M., Seki N., Kikuchi K., Kijima H., Itoi E. Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: from mass-screening in one village. J Orthop. 2013;10(1):8–12. doi: 10.1016/j.jor.2013.01.008.Oh LS., Wolf BR., Hall MP., Levy BA., Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007;455:52–63. doi: 10.1097/BLO.0b013e31802fc175.Oh LS., Wolf BR., Hall MP., Levy BA., Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007;455:52–63. doi: 10.1097/BLO.0b013e31802fc175.Kang SW., Park CK., Woo SH., Kim TW., Moon MH., Yang JH., Choi MH. Factors Influencing the Size of a Non-Traumatic Full-Thickness Rotator Cuff Tear: Focusing on Socioeconomic Factors. Int J Environ Res Public Health. 2022 May 18;19(10):6137. doi: 10.3390/ijerph19106137.Kang SW., Park CK., Woo SH., Kim TW., Moon MH., Yang JH., Choi MH. Factors Influencing the Size of a Non-Traumatic Full-Thickness Rotator Cuff Tear: Focusing on Socioeconomic Factors. Int J Environ Res Public Health. 2022 May 18;19(10):6137. doi: 10.3390/ijerph19106137.Lapner P., Henry P., Athwal G., Moktar J., McNeil D., MacDonald P. Canadian Shoulder and Elbow Society (CSES). Position statement: management of rotator cuff tears in adults. Can J Surg. 2023 Apr 21;66(2):E190-E195. doi: 10.1503/cjs.022221.Lapner P., Henry P., Athwal G., Moktar J., McNeil D., MacDonald P. Canadian Shoulder and Elbow Society (CSES). Position statement: management of rotator cuff tears in adults. Can J Surg. 2023 Apr 21;66(2):E190-E195. doi: 10.1503/cjs.022221.Yamamoto N., Mineta M., Kawakami J., Sano H., Itoi E. Risk factors for tear progression in symptomatic rotator cuff tears: A prospective study of 174 shoulders. Am. J. Sports Med. 2017, 45, 2524–2531. doi: 10.1177/0363546517709780. Epub 2017 Jun 13.Yamamoto N., Mineta M., Kawakami J., Sano H., Itoi E. Risk factors for tear progression in symptomatic rotator cuff tears: A prospective study of 174 shoulders. Am. J. Sports Med. 2017, 45, 2524–2531. doi: 10.1177/0363546517709780. Epub 2017 Jun 13.Longo UG., Carnevale A., Piergentili I., Berton A., Candela V., Schena E., Denaro V. Retear rates after rotator cuff surgery: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2021 Aug 31;22(1):749. doi: 10.1186/s12891-021-04634-6.Longo UG., Carnevale A., Piergentili I., Berton A., Candela V., Schena E., Denaro V. Retear rates after rotator cuff surgery: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2021 Aug 31;22(1):749. doi: 10.1186/s12891-021-04634-6.Zhao J., Luo M., Pan J., Liang G., Feng W., Zeng L., Yang W., Liu J. Risk factors affecting rotator cuff retear after arthroscopic repair: A metaanalysis and systematic review. J. Shoulder Elb. Surg. 2021;30:2660–2670. doi: 10.1016/j.jse.2021.05.010.Zhao J., Luo M., Pan J., Liang G., Feng W., Zeng L., Yang W., Liu J. Risk factors affecting rotator cuff retear after arthroscopic repair: A metaanalysis and systematic review. J. Shoulder Elb. Surg. 2021;30:2660–2670. doi: 10.1016/j.jse.2021.05.010.Parikh N., Martinez DJ., Winer I., Costa L., Dua D., Trueman P. Direct and indirect economic burden associated with rotator cuff tears and repairs in the US. Curr Med Res Opin. 2021 Jul;37(7):1199-1211. doi: 10.1080/03007995.2021.1918074. Epub 2021 May 19.Parikh N., Martinez DJ., Winer I., Costa L., Dua D., Trueman P. Direct and indirect economic burden associated with rotator cuff tears and repairs in the US. Curr Med Res Opin. 2021 Jul;37(7):1199-1211. doi: 10.1080/03007995.2021.1918074. Epub 2021 May 19.Rognoni C., Nherera LM., Garofalo R., Guerra E., Longo UG., Taverna E., Tarricone R. Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy. Adv Ther. 2023 Dec;40(12):5271-5284. doi: 10.1007/s12325-023-02686-9.Rognoni C., Nherera LM., Garofalo R., Guerra E., Longo UG., Taverna E., Tarricone R. Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy. Adv Ther. 2023 Dec;40(12):5271-5284. doi: 10.1007/s12325-023-02686-9.Goutallier D., Postel JM., Bernageau J., Lavau L., Voisin MC. Fatty infiltration of disrupted rotator cuff muscles. Rev Rhum Engl Ed. 1995 Jun;62(6):415-22. doi: 10.1097/00003086– 199407000–00014.Goutallier D., Postel JM., Bernageau J., Lavau L., Voisin MC. Fatty infiltration of disrupted rotator cuff muscles. Rev Rhum Engl Ed. 1995 Jun;62(6):415-22. doi: 10.1097/00003086– 199407000–00014.Patte D. Classification of Rotator Cuff Lesions. Clinical Orthopaedics and Related Research 254(): p 81-86, May 1990.Patte D. Classification of Rotator Cuff Lesions. Clinical Orthopaedics and Related Research 254(): p 81-86, May 1990.Narulla R., Song M., Karunaratne S., Smithers C., Petchell J. Trends in shoulder surgery patient-reported outcome measures. JSES Int. 2023 Apr 8;7(4):653-661. doi: 10.1016/j.jseint.2023.03.010.Narulla R., Song M., Karunaratne S., Smithers C., Petchell J. Trends in shoulder surgery patient-reported outcome measures. JSES Int. 2023 Apr 8;7(4):653-661. doi: 10.1016/j.jseint.2023.03.010.Sugaya H., Maeda K., Matsuki K., Moriishi J. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: singlerow versus dual-row fixation. Arthroscopy. 2005 Nov;21(11):1307-16. doi: 10.1016/j.arthro.2005.08.011.Sugaya H., Maeda K., Matsuki K., Moriishi J. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: singlerow versus dual-row fixation. Arthroscopy. 2005 Nov;21(11):1307-16. doi: 10.1016/j.arthro.2005.08.011.Kovacevic D., Suriani RJ., Jr, Grawe BM., Yian EH., Gilotra MN., Hasan SA., Srikumaran U., Hasan SS., Cuomo F., Burks RT., et al. Management of irreparable massive rotator cuff tears: a systematic review and meta-analysis of patient-reported outcomes, reoperation rates, and treatment response. J Shoulder Elb Surg / Am Shoulder Elb Surg [et al 2020;29(12):2459–75. doi: 10.1016/j.jse.2020.07.030.Kovacevic D., Suriani RJ., Jr, Grawe BM., Yian EH., Gilotra MN., Hasan SA., Srikumaran U., Hasan SS., Cuomo F., Burks RT., et al. Management of irreparable massive rotator cuff tears: a systematic review and meta-analysis of patient-reported outcomes, reoperation rates, and treatment response. J Shoulder Elb Surg / Am Shoulder Elb Surg [et al 2020;29(12):2459–75. doi: 10.1016/j.jse.2020.07.030.Kuan FC., Shih CA., Su WR., Garcia AV., Kuroiwa T., Iida N., Hsu KL. Definition of irreparable rotator cuff tear: a scoping review of prospective surgical therapeutic trials to evaluate current practice. BMC Musculoskelet Disord. 2023 Dec 8;24(1):952. doi: 10.1186/s12891-023-07067-5.Kuan FC., Shih CA., Su WR., Garcia AV., Kuroiwa T., Iida N., Hsu KL. Definition of irreparable rotator cuff tear: a scoping review of prospective surgical therapeutic trials to evaluate current practice. BMC Musculoskelet Disord. 2023 Dec 8;24(1):952. doi: 10.1186/s12891-023-07067-5.Щербак С. Г., Макаренко С. В., Шнейдер О.В., Камилова Т. А., Голота А. С. Регенеративная реабилитация при повреждениях сухожилий // Физическая и реабилитационная медицина, медицинская реабилитация. 2021;3(2): 192–206. doi: https://doi.org/10.36425/rehab70760.Sсherbak S.G., Makarenko S.V., Shneider O.V., Kamilova T.A., Golota A.S. Regenerative Rehabilitation in Injuries of Tendons // Physical and rehabilitation medicine, medical rehabilitation. 2021; 3(2): 192–206. doi: 10.36425/rehab70760.Bono OJ., Jenkin B., Forlizzi J., Mousad A., Le Breton S., MacAskill M., Mandalia K., Mithoefer K., Ramappa A., Ross G., Shah SS. Evidence for Utilization of Injectable Biologic Augmentation in Primary Rotator Cuff Repair: A Systematic Review of Data From 2010 to 2022. Orthop J Sports Med. 2023 Feb 3;11(2):23259671221150037. doi: 10.1177/23259671221150037.Bono OJ., Jenkin B., Forlizzi J., Mousad A., Le Breton S., MacAskill M., Mandalia K., Mithoefer K., Ramappa A., Ross G., Shah SS. Evidence for Utilization of Injectable Biologic Augmentation in Primary Rotator Cuff Repair: A Systematic Review of Data From 2010 to 2022. Orthop J Sports Med. 2023 Feb 3;11(2):23259671221150037. doi: 10.1177/23259671221150037.Prabhakar A., Kanthalu Subramanian JN., Swathikaa P., Kumareswaran SI., Subramanian KN. Current concepts on management of cuff tear. J Clin Orthop Trauma. 2022 Feb 18; 28:101808. doi: 10.1016/j.jcot.2022.101808.Prabhakar A., Kanthalu Subramanian JN., Swathikaa P., Kumareswaran SI., Subramanian KN. Current concepts on management of cuff tear. J Clin Orthop Trauma. 2022 Feb 18; 28:101808. doi: 10.1016/j.jcot.2022.101808.Goldenberg BT., Lacheta L., Dekker TJ., Spratt JD., Nolte PC., Millett PJ. Biologics to Improve Healing in Large and Massive Rotator Cuff Tears: A Critical Review. Orthop Res Rev. 2020 Oct 13;12:151-160. doi: 10.2147/ORR.S260657.Goldenberg BT., Lacheta L., Dekker TJ., Spratt JD., Nolte PC., Millett PJ. Biologics to Improve Healing in Large and Massive Rotator Cuff Tears: A Critical Review. Orthop Res Rev. 2020 Oct 13;12:151-160. doi: 10.2147/ORR.S260657.Cole BJ., Kaiser JT., Wagner KR., Sivasundaram L., Otte RS., Tauro TM., White GM., Ralls ML., Yanke A.B, Forsythe B., Romeo AA., Verma NN. Prospective Randomized Trial of Biologic Augmentation With Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair. Am J Sports Med. 2023 Apr;51(5):1234-1242. doi: 10.1177/03635465231154601. Epub 2023 Feb 22.Cole BJ., Kaiser JT., Wagner KR., Sivasundaram L., Otte RS., Tauro TM., White GM., Ralls ML., Yanke A.B, Forsythe B., Romeo AA., Verma NN. Prospective Randomized Trial of Biologic Augmentation With Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair. Am J Sports Med. 2023 Apr;51(5):1234-1242. doi: 10.1177/03635465231154601. Epub 2023 Feb 22.Zou J., Yang W., Cui W., Li C., Ma C., Ji X., Hong J., Qu Z., Chen J., Liu A., Wu H. Therapeutic potential and mechanisms of mesenchymal stem cell-derived exosomes as bioactive materials in tendon-bone healing. J Nanobiotechnology. 2023 Jan 16;21(1):14. doi: 10.1186/s12951-023-01778-6.Zou J., Yang W., Cui W., Li C., Ma C., Ji X., Hong J., Qu Z., Chen J., Liu A., Wu H. Therapeutic potential and mechanisms of mesenchymal stem cell-derived exosomes as bioactive materials in tendon-bone healing. J Nanobiotechnology. 2023 Jan 16;21(1):14. doi: 10.1186/s12951-023-01778-6.Zhong W., Sumita Y., Ohba S., et al. In vivo comparison of the bone regeneration capability of human bone marrow concentrates vs. plateletrich plasma. PLoS One. 2012;7. doi: 10.1371/journal.pone.0040833.Zhong W., Sumita Y., Ohba S., et al. In vivo comparison of the bone regeneration capability of human bone marrow concentrates vs. plateletrich plasma. PLoS One. 2012;7. doi: 10.1371/journal.pone.0040833.Schoch BS., Werner BC., Shapiro SA., Camp CL., Chalmers PN., Cancienne JM. Effect of Bone Marrow Aspirate Concentrate and Platelet-Rich Plasma Augmentation on the Rate of Revision Rotator Cuff Repair. Orthop J Sports Med. 2022 Nov 3;10(11):23259671221127004. doi: 10.1177/23259671221127004.Schoch BS., Werner BC., Shapiro SA., Camp CL., Chalmers PN., Cancienne JM. Effect of Bone Marrow Aspirate Concentrate and Platelet-Rich Plasma Augmentation on the Rate of Revision Rotator Cuff Repair. Orthop J Sports Med. 2022 Nov 3;10(11):23259671221127004. doi: 10.1177/23259671221127004.Piuzzi NS., Hussain ZB., Chahla J., Cinque ME., Moatshe G., Mantripragada VP., Muschler G.F, LaPrade RF. Variability in the Preparation, Reporting, and Use of Bone Marrow Aspirate Concentrate in Musculoskeletal Disorders: A Systematic Review of the Clinical Orthopaedic Literature. J Bone Joint Surg Am. 2018 Mar 21;100(6):517-525. doi: 10.2106/JBJS.17.00451.Piuzzi NS., Hussain ZB., Chahla J., Cinque ME., Moatshe G., Mantripragada VP., Muschler G.F, LaPrade RF. Variability in the Preparation, Reporting, and Use of Bone Marrow Aspirate Concentrate in Musculoskeletal Disorders: A Systematic Review of the Clinical Orthopaedic Literature. J Bone Joint Surg Am. 2018 Mar 21;100(6):517-525. doi: 10.2106/JBJS.17.00451.Kovacevic D., Suriani RJ. Jr., Levine WN., Thomopoulos S. Augmentation of Rotator Cuff Healing With Orthobiologics. J Am Acad Orthop Surg. 2022 Mar 1;30(5):e508-e516. doi: 10.5435/JAAOSD-20-01011.Kovacevic D., Suriani RJ. Jr., Levine WN., Thomopoulos S. Augmentation of Rotator Cuff Healing With Orthobiologics. J Am Acad Orthop Surg. 2022 Mar 1;30(5):e508-e516. doi: 10.5435/JAAOSD-20-01011.Voss A., McCarthy MB., Bellas N., Kellner R., Beitzel K., Dyrna F., Imhoff AB., Mazzocca AD., Muench LN., Berthold DP. Significant Improvement in Shoulder Function and Pain in Patients Following Biologic Augmentation of Revision Arthroscopic Rotator Cuff Repair Using an Autologous Fibrin Scaffold and Bone Marrow Aspirate Derived From the Proximal Humerus. Arthrosc Sports Med Rehabil. 2021 Oct 30;3(6):e1819-e1825. doi: 10.1016/j.asmr.2021.08.009.Voss A., McCarthy MB., Bellas N., Kellner R., Beitzel K., Dyrna F., Imhoff AB., Mazzocca AD., Muench LN., Berthold DP. Significant Improvement in Shoulder Function and Pain in Patients Following Biologic Augmentation of Revision Arthroscopic Rotator Cuff Repair Using an Autologous Fibrin Scaffold and Bone Marrow Aspirate Derived From the Proximal Humerus. Arthrosc Sports Med Rehabil. 2021 Oct 30;3(6):e1819-e1825. doi: 10.1016/j.asmr.2021.08.009.

The authors declare that there are no conflicts of interest present.