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

NCT05860673 | Recruiting

• 1 other identifier: MISpro
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

posterior spinal fusion; mini invasive scoliosis surgery; Adolescent Idiopathic Scoliosis; randomized trial

Outcome Measures

Primary Outcomes (1)

• Cobb angle measurement

  Cobb's angle represents the gold standard for measuring the extent of the scoliotic curve; it is identified as the angle between the two lines passing through the upper limiting vertebra and the lower limiting vertebra on an antero-posterior radiogram of the spine.

  12 months follow-up

Secondary Outcomes (8)

• Cobb angle measurement

  baseline (post-surgery), 2 months, 6 months, 24 months and 60 months follow-up

• NRS (Numeric Rating Scale)

  baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up

• SRS-22 (Scoliosis Research Society-22)

  baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up

• Oswestry Disability Index (ODI)

  baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up

• Final treatment opinion

  2 months, 6 months, 12 months, 24 months and 60 months follow-up

Study Arms (2)

mini invasive scoliosis surgery (MIS)

EXPERIMENTAL

This technique involves making small, noncontiguous, midline skin incisions at the levels to be instrumented, usually proximal and distal to the area of arthrodesis. A median fascial incision is then made to expose the vertebral segments on which to thread the screws while the bar is inserted submuscularly in a cranio-caudal direction, after appropriate maneuvers to correct the deformity.

Procedure: mini invasive scoliosis surgery

posterior spinal fusion technique (PSF)

ACTIVE COMPARATOR

This technique is the surgical gold standard. It consists of an instrumented arthrodesis with posterior access and requires a wide median incision with extensive muscle dissection.

Procedure: posterior spinal fusion technique

Interventions

mini invasive scoliosis surgery PROCEDURE

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 posterior elements are performed to facilitate correction of the metameres.

mini invasive scoliosis surgery (MIS)

posterior spinal fusion technique PROCEDURE

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 derotation maneuvers is continued, and the obtained correction is fixed with pre-shaped bars that are then connected to the screws and tightened to the nuts by dynamometric technique. Almost all vertebral levels of the thoracolumbar tract are included in the arthrodesis

posterior spinal fusion technique (PSF)

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

Study Officials

• Alessandro Gasbarrini, MD

  Istituto Ortopedico Rizzoli - Chirurgia vertebrale

  PRINCIPAL INVESTIGATOR

• Bruna Maccaferri, MD

  Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

  STUDY CHAIR

• Francesco Vommaro, MD

  Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

  STUDY CHAIR

• Giovanni Ciani, MD

  Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

  STUDY CHAIR

• Lucrezia Leggi, MD

  Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

  STUDY CHAIR

Central Study Contacts

Alessandro Gasbarrini, MD

CONTACT

6366528; alessandro.gasbarrini@ior.it

Bruna Maccaferri, MD

CONTACT

6366567; bruna.maccaferri@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized trial with 1:1 allocation.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 16, 2023
• Study Start: July 15, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2032
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

IT (1)