Clinical trial NCT05860673: Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis
Official title: Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis: Randomized Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: posterior spinal fusion
mini invasive scoliosis surgery
Adolescent Idiopathic Scoliosis
randomized trial
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 126
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized trial with 1:1 allocation.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Cobb angle measurement
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Cobb angle measurement
timeFrame: baseline (post-surgery), 2 months, 6 months, 24 months and 60 months follow-up
measure: NRS (Numeric Rating Scale)
timeFrame: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
measure: SRS-22 (Scoliosis Research Society-22)
timeFrame: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
measure: Oswestry Disability Index (ODI)
timeFrame: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
measure: Final treatment opinion
timeFrame: 2 months, 6 months, 12 months, 24 months and 60 months follow-up
measure: Screw malposition rate
timeFrame: 6 months
measure: Incidence of mechanical complications
timeFrame: 2 months, 6 months, 12 months, 24 months and 60 months of follow-up
measure: Intraoperative and immediate postoperative outcomes
timeFrame: through study completion, up to 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli - Chirurgia vertebrale
name: Alessandro Gasbarrini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Ortopedico Rizzoli -Chirurgia Vertebrale
name: Bruna Maccaferri, MD
role: STUDY_CHAIR
affiliation: Istituto Ortopedico Rizzoli -Chirurgia Vertebrale
name: Francesco Vommaro, MD
role: STUDY_CHAIR
affiliation: Istituto Ortopedico Rizzoli -Chirurgia Vertebrale
name: Giovanni Ciani, MD
role: STUDY_CHAIR
affiliation: Istituto Ortopedico Rizzoli -Chirurgia Vertebrale
name: Lucrezia Leggi, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.