About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
mini invasive scoliosis surgery
Procedure/SurgeryThe 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
Procedure/SurgeryThe 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
NRS (Numeric Rating Scale)
NRS is a quantitative one-dimensional numerical scale, used to measure pain intensity, involves the practitioner asking the patient to select the number that best describes the intensity of his or her pain, from 0 to 10, at that specific time.
SRS-22 (Scoliosis Research Society-22)
SRS-22 is a questionnaire that is the most common measure for assessing quality of life in patients with spinal deformities. assesses five domains: 1. function 2. pain 3. mental health 4. self-image 5. satisfaction/ dissatisfaction Each domain contains five questions, except for the last one, which has two questions. The score for each question ranges from 1 to 5. The sum of the first four domains forms an initial partial score, which can be up to 100. The total score is given by adding the last item as well, for a maximum score of 110. The purpose of the SRS-22 is to provide an assessment of pathology and patient perception regarding both the consequences of treatment choices and the effectiveness of treatment.
Oswestry Disability Index (ODI)
The ODI index is a valuable tool for assessing patient satisfaction in view of the patient's current clinical picture. It consists of ten sections investigating the influence of spinal pathology on different aspects of daily life: (pain intensity; personal hygiene; lifting weights; walking; sitting; standing; sleeping; sexual life; social life; traveling). Each section contains within it 6 possible answers with scores ranging from 0 to 5 where 0 corresponds to no difficulty or pain while 5 inability to perform the activity or disabling pain
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