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

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Adolescent Idiopathic Scoliosis

Treatments: Procedure: mini invasive scoliosis surgery; Procedure: posterior spinal fusion technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05860673

MISpro

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

mini invasive scoliosis surgery (MIS)

Experimental group

Description:

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.

Treatment:

Procedure: mini invasive scoliosis surgery

posterior spinal fusion technique (PSF)

Active Comparator group

Description:

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.

Treatment:

Procedure: posterior spinal fusion technique