NCT05860673

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
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

Timeline

• Start date: 2023-07-15
• Primary completion: 2027-06-01
• Completion: 2032-06-01
• First posted: 2023-05-16
• Last updated: 2025-06-04

Locations

1 site across 1 country: Italy