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

NCT ID: NCT05860673

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2032-06-30

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mini invasive scoliosis surgery (MIS)

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.

Group Type: EXPERIMENTAL

mini invasive scoliosis surgery

Intervention Type: 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.

posterior spinal fusion technique (PSF)

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.

Group Type: ACTIVE_COMPARATOR

posterior spinal fusion technique

Intervention Type: 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

Interventions

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 posterior elements are performed to facilitate correction of the metameres.

Intervention Type: PROCEDURE

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 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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Gasbarrini, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli - Chirurgia vertebrale

Bruna Maccaferri, MD

Role: STUDY_CHAIR

Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

Francesco Vommaro, MD

Role: STUDY_CHAIR

Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

Giovanni Ciani, MD

Role: STUDY_CHAIR

Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

Lucrezia Leggi, MD

Role: STUDY_CHAIR

Istituto Ortopedico Rizzoli -Chirurgia Vertebrale

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessandro Gasbarrini, MD

Role: CONTACT

alessandro.gasbarrini@ior.it

6366528 ext. 051

Bruna Maccaferri, MD

Role: CONTACT

bruna.maccaferri@ior.it

6366567 ext. 051

Facility Contacts

Alessandro Gasbarrini, MD

Role: primary

alessandro.gasbarrini@ior.it

Bruna Maccaferri, MD

Role: backup

bruna.maccaferri@ior.it

References

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.

Reference Type: BACKGROUND

PMID: 24284269 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24852384 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34517401 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33557618 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33966365 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32720126 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39013643 (View on PubMed)

Other Identifiers

MISpro

Identifier Type: -

Identifier Source: org_study_id