RecruitingNot ApplicableNCT05860673

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.


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

126 participants

Start Date

Jul 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 25 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria7

  • 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.

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Interventions

PROCEDUREmini 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.

PROCEDUREposterior 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


Locations(1)

Istituto Ortopedico Rizzoli

Bologna, Italy

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NCT05860673


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