Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis

Официальное название

Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis: Randomized Trial.

Обзор

This is a randomized trial with 1:1 allocation. The aim of the study is to evaluate clinical and radiographic outcomes in patients with developmental age idiopathic scoliosis treated with mini invasive scoliosis surgery (MIS) technique versus posterior spinal fusion (PSF) technique through clinical and radiographic evaluations.

Подробное описание

Patients with developmental age idiopathic scoliosis will be included in a randomized trial in which one group of patients will be treated with mini invasive scoliosis surgery technique , and one group will be treated instead with traditional posterior spinal fusion arthrodesis. The study design involves a noninferiority evaluation, assuming that MIS does not produce inferior results to the classic technique from the point of view of curve correction. This result would be important, because with equal curve correction success, the risk/benefit balance for minimally invasive surgery is superior, as it reduces the risk of transfusion and postoperative pain. The results of this study could therefore give important guidance for surgeons on choosing the optimal treatment for patients.

Patients will be evaluated by clinical examination, before the surgical procedure and at subsequent follow-ups as per clinical practice: at 2, 6, 12, 24, 60 months after treatment by medical personnel.

During the selection visit, patients will also be evaluated with radiographic examination for measurements necessary to decide the indication for surgical treatment. The patient also undergoes postoperative radiographic examination before discharge, as well as at follow-ups at 2, 6, 12, 24, and 60 months.

Вмешательства

• Процедура mini invasive scoliosis surgery
  The minimally invasive technique, involves two small median skin incisions that allow the deep structures to be exposed. The muscle fibers are separated from the bony insertion by the process of subperiosteal "skeletonization." The Investigators then proceed with the arthrectomy of the levels to be instrumented and the infiltration of pedicle screw pairs of the appropriate caliber according to the "free-hand" technique. After amplioscopic control of proper screw placement, osteotomies of the pos
• Процедура posterior spinal fusion technique
  The standard open technique involves a longitudinal incision along the midline extended along the entire thoracolumbar spine, the paravertebral muscles are incised and spread apart to expose the posterior vertebral structures, in a stretch extending more than 30 cm. The series of facetectomies are performed first, and then pairs of pedicle screws are infixed freehand. After performing the osteotomies necessary to mobilize the vertebral metameres at the apex of the deformity, correction by derot

Первичные конечные точки

• Cobb angle measurement [Срок оценки: 12 months follow-up]

Вторичные конечные точки (8)

• Cobb angle measurement [Срок оценки: baseline (post-surgery), 2 months, 6 months, 24 months and 60 months follow-up]
• NRS (Numeric Rating Scale) [Срок оценки: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up]
• SRS-22 (Scoliosis Research Society-22) [Срок оценки: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up]
• Oswestry Disability Index (ODI) [Срок оценки: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up]
• Final treatment opinion [Срок оценки: 2 months, 6 months, 12 months, 24 months and 60 months follow-up]
• Screw malposition rate [Срок оценки: 6 months]
• Incidence of mechanical complications [Срок оценки: 2 months, 6 months, 12 months, 24 months and 60 months of follow-up]
• Intraoperative and immediate postoperative outcomes [Срок оценки: through study completion, up to 5 years]

Критерии участия

Критерии включения

• Patients with AIS
• Age between 12 and 25 years;
• Site of scoliotic curve: thoracic and/or lumbar;
• Preoperative radiographic range of the main scoliotic curve between 40° and 70° according to Cobb;
• Ability and consent of patients/parents to actively participate in the study and clinical follow-up.

Критерии исключения

• Patients already treated surgically for scoliosis;
• Site of the scoliotic curve: cervical;
• Patients with scoliosis other than adolescent idiopathic scoliosis;
• Patients who do not fall within the described parameters;
• Unbalanced sagittal profile;
• Patients unable to consent or perform follow-ups.
• Pregnant women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Istituto Ortopedico Rizzoli — Bologna

Публикации

• Shakil H, Iqbal ZA, Al-Ghadir AH. Scoliosis: review of types of curves, etiological theories and conservative treatment. J Back Musculoskelet Rehabil. 2014;27(2):111-5. doi: 10.3233/BMR-130438. PMID 24284269
• Sarwahi V, Horn JJ, Kulkarni PM, Wollowick AL, Lo Y, Gambassi M, Amaral TD. Minimally Invasive Surgery in Patients With Adolescent Idiopathic Scoliosis: Is it Better than the Standard Approach? A 2-Year Follow-up Study. Clin Spine Surg. 2016 Oct;29(8):331-40. doi: 10.1097/BSD.0000000000000106. PMID 24852384
• Sarwahi V, Galina JM, Hasan S, Atlas A, Ansorge A, De Bodman C, Lo Y, Amaral TD, Dayer R. Minimally Invasive Versus Standard Surgery in Idiopathic Scoliosis Patients: A Comparative Study. Spine (Phila Pa 1976). 2021 Oct 1;46(19):1326-1335. doi: 10.1097/BRS.0000000000004011. PMID 34517401
• Alhammoud A, Alborno Y, Baco AM, Othman YA, Ogura Y, Steinhaus M, Sheha ED, Qureshi SA. Minimally Invasive Scoliosis Surgery Is a Feasible Option for Management of Idiopathic Scoliosis and Has Equivalent Outcomes to Open Surgery: A Meta-Analysis. Global Spine J. 2022 Apr;12(3):483-492. doi: 10.1177/2192568220988267. Epub 2021 Feb 9. PMID 33557618
• Neradi D, Kumar V, Kumar S, Sodavarapu P, Goni V, Dhatt SS. Minimally Invasive Surgery versus Open Surgery for Adolescent Idiopathic Scoliosis: A Systematic Review and Meta-Analysis. Asian Spine J. 2022 Apr;16(2):279-289. doi: 10.31616/asj.2020.0605. Epub 2021 May 11. PMID 33966365
• Si G, Li T, Wang Y, Liu X, Li C, Yu M. Minimally invasive surgery versus standard posterior approach for Lenke Type 1-4 adolescent idiopathic scoliosis: a multicenter, retrospective study. Eur Spine J. 2021 Mar;30(3):706-713. doi: 10.1007/s00586-020-06546-w. Epub 2020 Jul 27. PMID 32720126
• Maccaferri B, Filardo G, Cini C, Gasbarrini A, Vommaro F. Adolescent idiopathic scoliosis: a prospective randomised trial protocol comparing clinical and radiological outcomes in minimally invasive surgery versus standard posterior spinal fusion in a single-centre, the Rizzoli Orthopaedic Institute, Bologna, Italy. BMJ Open. 2024 Jul 16;14(7):e075802. doi: 10.1136/bmjopen-2023-075802. PMID 39013643

Идентификаторы

NCT: NCT05860673 · MISpro

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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