Adolescent Idiopathic ScoliosisNCT05860673
Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis
A study testing mini invasive scoliosis surgery and posterior spinal fusion technique in people with Adolescent Idiopathic Scoliosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- mini invasive scoliosis surgery and posterior spinal fusion technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2023to Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Alessandro Gasbarrini, MD, alessandro.gasbarrini@ior.it
Bruna Maccaferri, MD, bruna.maccaferri@ior.it
About this study
Official title: Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis: Randomized 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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- mini invasive scoliosis surgery, posterior spinal fusion technique
- Keywords
- posterior spinal fusion, mini invasive scoliosis surgery, Adolescent Idiopathic Scoliosis, randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini invasive scoliosis surgeryProcedure or 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 techniqueProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| mini invasive scoliosis surgery (MIS) | Experimental | 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. Receives: Procedure: mini invasive scoliosis surgery |
| posterior spinal fusion technique (PSF) | Active comparator | 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. Receives: Procedure: posterior spinal fusion technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months follow-up
Secondary outcomes (8)
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.
Measured: baseline (post-surgery), 2 months, 6 months, 24 months and 60 months follow-up
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.
Measured: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
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.
Measured: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
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
Measured: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
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".
Measured: 2 months, 6 months, 12 months, 24 months and 60 months follow-up
Screw malposition rate
Screw malposition rate will be evaluated by a CT scan and the Brantigan score will be applied to document screw fusion.
Measured: 6 months
Incidence of mechanical complications
Rod Fracture, screw loosening or junctional kyphosis will be evaluated with radiographs
Measured: 2 months, 6 months, 12 months, 24 months and 60 months of follow-up
Intraoperative and immediate postoperative outcomes
Differences in terms of operative time, blood loss, length of stay, time to verticalization, drug use
Measured: through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Jul 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized trial with 1:1 allocation.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Gasbarrini, MD, Principal investigator, Istituto Ortopedico Rizzoli - Chirurgia vertebraleBruna Maccaferri, MD, Study chair, Istituto Ortopedico Rizzoli -Chirurgia VertebraleFrancesco Vommaro, MD, Study chair, Istituto Ortopedico Rizzoli -Chirurgia VertebraleGiovanni Ciani, MD, Study chair, Istituto Ortopedico Rizzoli -Chirurgia VertebraleLucrezia Leggi, MD, Study chair, Istituto Ortopedico Rizzoli -Chirurgia Vertebrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860673
- Sponsor's protocol ID
- MISpro
- Status last verified
- Jun 2025
- First submitted
- 8 May 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24284269Sarwahi 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.
PubMed 24852384Sarwahi 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.
PubMed 34517401Alhammoud 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.
PubMed 33557618Neradi 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.
PubMed 33966365Si 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.
PubMed 32720126Maccaferri B, Filardo G, Cini C, Gasbarrini A, Vommaro F. Adolescent idiopathic scoliosis: a prospective randomised trial protocol comparing clinical and radiological outcomes in minimally invasive surgery versus standard posterior spinal fusion in a single-centre, the Rizzoli Orthopaedic Institute, Bologna, Italy. BMJ Open. 2024 Jul 16;14(7):e075802. doi: 10.1136/bmjopen-2023-075802.
PubMed 39013643
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis: Randomized Trial.
- ClinicalTrials.gov ID
- NCT05860673
- Acronym / sponsor ID
- MISpro
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- posterior spinal fusion, mini invasive scoliosis surgery, Adolescent Idiopathic Scoliosis, randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized trial with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| mini invasive scoliosis surgery (MIS) | Experimental | Procedure: mini invasive scoliosis surgeryThis 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. |
| posterior spinal fusion technique (PSF) | Active comparator | Procedure: posterior spinal fusion techniqueThis 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. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mini invasive scoliosis 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. | Procedure or surgery | mini invasive scoliosis surgery (MIS) |
| posterior spinal fusion techniqueThe 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 | Procedure or surgery | posterior spinal fusion technique (PSF) |
Primary outcome
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.
8 secondary outcomes
Cobb angle measurement
Time frame: baseline (post-surgery), 2 months, 6 months, 24 months and 60 months follow-up
NRS (Numeric Rating Scale)
Time frame: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
SRS-22 (Scoliosis Research Society-22)
Time frame: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
Oswestry Disability Index (ODI)
Time frame: baseline, 2 months, 6 months, 12 months, 24 months and 60 months follow-up
Final treatment opinion
Time frame: 2 months, 6 months, 12 months, 24 months and 60 months follow-up
Screw malposition rate
Time frame: 6 months
Incidence of mechanical complications
Time frame: 2 months, 6 months, 12 months, 24 months and 60 months of follow-up
Intraoperative and immediate postoperative outcomes
Time frame: through study completion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 24284269Shakil 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.
- Background: PubMed 24852384Sarwahi 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.
- Background: PubMed 34517401Sarwahi 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.
- Background: PubMed 33557618Alhammoud 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.
- Background: PubMed 33966365Neradi 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.
- Background: PubMed 32720126Si 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.
- Derived from this study: PubMed 39013643Maccaferri B, Filardo G, Cini C, Gasbarrini A, Vommaro F. Adolescent idiopathic scoliosis: a prospective randomised trial protocol comparing clinical and radiological outcomes in minimally invasive surgery versus standard posterior spinal fusion in a single-centre, the Rizzoli Orthopaedic Institute, Bologna, Italy. BMJ Open. 2024 Jul 16;14(7):e075802. doi: 10.1136/bmjopen-2023-075802.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro Gasbarrini, MD principal investigator
Istituto Ortopedico Rizzoli - Chirurgia vertebrale
Bruna Maccaferri, MD study chair
Istituto Ortopedico Rizzoli -Chirurgia Vertebrale
Francesco Vommaro, MD study chair
Istituto Ortopedico Rizzoli -Chirurgia Vertebrale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mini invasive scoliosis surgery and posterior spinal fusion technique in people with Adolescent Idiopathic Scoliosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Gasbarrini, MD (6366528 ext. 051, alessandro.gasbarrini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle measurement (time frame: 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05860673, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.