Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis
- Conditions
- Adolescent Idiopathic Scoliosis
- Interventions
- Procedure: posterior spinal fusion techniqueProcedure: mini invasive scoliosis surgery
- Registration Number
- NCT05860673
- Lead Sponsor
- Istituto Ortopedico Rizzoli
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description posterior spinal fusion technique (PSF) posterior spinal fusion technique 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. mini invasive scoliosis surgery (MIS) mini invasive scoliosis surgery 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.
- Primary Outcome Measures
Name Time Method Cobb angle measurement 12 months follow-up 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 Outcome Measures
Name Time Method NRS (Numeric Rating Scale) baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up 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.
Cobb angle measurement baseline (post-surgery), 2 months, 6 months, 24 months and 60 months follow-up 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.
Screw malposition rate 6 months Screw malposition rate will be evaluated by a CT scan and the Brantigan score will be applied to document screw fusion.
Intraoperative and immediate postoperative outcomes through study completion, up to 5 years Differences in terms of operative time, blood loss, length of stay, time to verticalization, drug use
SRS-22 (Scoliosis Research Society-22) baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up 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) baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up 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 painFinal treatment opinion 2 months, 6 months, 12 months, 24 months and 60 months follow-up The patient should indicate satisfaction and relative degree with treatment. All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse".
Incidence of mechanical complications 2 months, 6 months, 12 months, 24 months and 60 months of follow-up Rod Fracture, screw loosening or junctional kyphosis will be evaluated with radiographs
Trial Locations
- Locations (1)
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy