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NCT Number: NCT05860673

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

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Alessandro Gasbarrini, MD

CONTACT

[email protected]

Alessandro Gasbarrini, MD

PRINCIPAL_INVESTIGATOR

Bruna Maccaferri, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

mini invasive scoliosis surgery

Procedure

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

Procedure

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

Primary outcomes

  1. Cobb angle measurement

    Time frame: 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 outcomes

  1. Cobb angle measurement

    Time frame: 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.

  2. NRS (Numeric Rating Scale)

    Time frame: 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.

  3. SRS-22 (Scoliosis Research Society-22)

    Time frame: 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:

    • 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.

  4. Oswestry Disability Index (ODI)

    Time frame: 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 pain

  5. Final treatment opinion

    Time frame: 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".

  6. Screw malposition rate

    Time frame: 6 months

    Screw malposition rate will be evaluated by a CT scan and the Brantigan score will be applied to document screw fusion.

  7. Incidence of mechanical complications

    Time frame: 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

  8. Intraoperative and immediate postoperative outcomes

    Time frame: through study completion, up to 5 years

    Differences in terms of operative time, blood loss, length of stay, time to verticalization, drug use

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Gasbarrini, MD

CONTACT

[email protected]

6366528 ext. 051

Bruna Maccaferri, MD

CONTACT

[email protected]

6366567 ext. 051

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2032
First posted
May 16, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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