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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860673
• Other study ID #: MISpro
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: June 2032

Study information

• Verified date: June 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Alessandro Gasbarrini, MD
• Phone: 6366528
• Email: alessandro.gasbarrini[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: June 2032
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Alhammoud A, Alborno Y, Baco AM, Othman YA, Ogura Y, Steinhaus M, Sheha ED, Qureshi SA. Minimally Invasive Scoliosis Surgery Is a Feasible Option for Management of Idiopathic Scoliosis and Has Equivalent Outcomes to Open Surgery: A Meta-Analysis. Global Spine J. 2022 Apr;12(3):483-492. doi: 10.1177/2192568220988267. Epub 2021 Feb 9. — View Citation

Neradi D, Kumar V, Kumar S, Sodavarapu P, Goni V, Dhatt SS. Minimally Invasive Surgery versus Open Surgery for Adolescent Idiopathic Scoliosis: A Systematic Review and Meta-Analysis. Asian Spine J. 2022 Apr;16(2):279-289. doi: 10.31616/asj.2020.0605. Epub 2021 May 11. — View Citation

Sarwahi V, Galina JM, Hasan S, Atlas A, Ansorge A, De Bodman C, Lo Y, Amaral TD, Dayer R. Minimally Invasive Versus Standard Surgery in Idiopathic Scoliosis Patients: A Comparative Study. Spine (Phila Pa 1976). 2021 Oct 1;46(19):1326-1335. doi: 10.1097/BRS.0000000000004011. — View Citation

Sarwahi V, Horn JJ, Kulkarni PM, Wollowick AL, Lo Y, Gambassi M, Amaral TD. Minimally Invasive Surgery in Patients With Adolescent Idiopathic Scoliosis: Is it Better than the Standard Approach? A 2-Year Follow-up Study. Clin Spine Surg. 2016 Oct;29(8):331-40. doi: 10.1097/BSD.0000000000000106. — View Citation

Shakil H, Iqbal ZA, Al-Ghadir AH. Scoliosis: review of types of curves, etiological theories and conservative treatment. J Back Musculoskelet Rehabil. 2014;27(2):111-5. doi: 10.3233/BMR-130438. — View Citation

Si G, Li T, Wang Y, Liu X, Li C, Yu M. Minimally invasive surgery versus standard posterior approach for Lenke Type 1-4 adolescent idiopathic scoliosis: a multicenter, retrospective study. Eur Spine J. 2021 Mar;30(3):706-713. doi: 10.1007/s00586-020-06546-w. Epub 2020 Jul 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months follow-up
Secondary	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.	baseline (post-surgery), 2 months, 6 months, 24 months and 60 months follow-up
Secondary	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.	baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
Secondary	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: function; pain; mental health; self-image; 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.	baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
Secondary	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	baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
Secondary	Final treatment opinion	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".	2 months, 6 months, 12 months, 24 months and 60 months follow-up
Secondary	Screw malposition rate	Screw malposition rate will be evaluated by a CT scan and the Brantigan score will be applied to document screw fusion.	6 months
Secondary	Incidence of mechanical complications	Rod Fracture, screw loosening or junctional kyphosis will be evaluated with radiographs	2 months, 6 months, 12 months, 24 months and 60 months of follow-up
Secondary	Intraoperative and immediate postoperative outcomes	Differences in terms of operative time, blood loss, length of stay, time to verticalization, drug use	through study completion, up to 5 years