Paralytic ScoliosisNCT07594574
Posterior Minimally Invasive Surgery for Treating Paralytic Scoliosis With Pelvic Obliquity in Children Following Spinal Cord Injury
A study testing Posterior Minimally Invasive Correction Surgery and Conventional Posterior Spinal Fusion in people with Paralytic Scoliosis and Pelvic Obliquity, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This randomized controlled trial compares posterior minimally invasive correction surgery with conventional posterior spinal fusion for children with paralytic scoliosis and severe pelvic obliquity following spinal cord injury. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Paralytic Scoliosis, Pelvic Obliquity, Spinal Cord Injury
- What is being tested?
- Posterior Minimally Invasive Correction Surgery and Conventional Posterior Spinal Fusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2024to 1 Sep 2026
- 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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6 to 20 years at the time of enrollment.
- Diagnosis of paralytic scoliosis secondary to spinal cord injury during childhood.
- Severe pelvic obliquity, defined as pelvic obliquity angle greater than 15 degrees on sitting full-spine anteroposterior radiographs.
- Major coronal scoliosis curve with Cobb angle greater than 40 degrees, or progressive deformity considered to require surgical correction by the treating spine deformity team.
- Nonambulatory status or severe lower-limb motor dysfunction after spinal cord injury.
- Planned surgical correction requiring spinopelvic fixation.
- Ability to undergo sitting full-spine radiographic assessment before surgery and during follow-up.
- Written informed consent provided by the parent or legal guardian, with participant assent when applicable.
Who cannot join
- Idiopathic scoliosis, congenital scoliosis, syndromic scoliosis, or spinal deformity caused by etiologies other than spinal cord injury.
- Neuromuscular scoliosis caused by cerebral palsy, spinal muscular atrophy, muscular dystrophy, myelomeningocele, poliomyelitis, or other primary neuromuscular diseases.
- Previous spinal deformity correction surgery or previous long-segment spinal fusion.
- Active systemic infection or uncontrolled local infection at the planned surgical site.
- Severe pressure ulcer, osteomyelitis, or soft tissue condition that precludes safe posterior spinal surgery.
- Severe cardiopulmonary, hematologic, hepatic, renal, or other systemic disease that makes the participant unsuitable for major spinal surgery.
Show all 9Show fewer
- Coagulation disorder or other condition associated with unacceptable bleeding risk.
- Inability to complete the planned follow-up schedule.
- Participation in another interventional trial that may affect the outcomes of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
About this study
This randomized controlled trial compares posterior minimally invasive correction surgery with conventional posterior spinal fusion for children with paralytic scoliosis and severe pelvic obliquity following spinal cord injury. Conventional posterior spinal fusion is widely used for severe neuromuscular or paralytic scoliosis but is associated with substantial surgical trauma, blood loss, transfusion requirements, and perioperative morbidity. The minimally invasive approach uses limited posterior incisions, posterior instrumentation, and spinopelvic fixation with second sacral alar-iliac screws. The study will evaluate whether minimally invasive surgery provides comparable correction of pelvic obliquity and spinal deformity while reducing perioperative surgical burden, complications, hospital stay, and medical costs.
Read the detailed description
Paralytic scoliosis following spinal cord injury in childhood is a specific subtype of neuromuscular scoliosis. Patients are often nonambulatory and may develop progressive long C-shaped thoracolumbar or lumbar curves, severe pelvic obliquity, impaired sitting balance, pain, hip dysplasia or subluxation, and functional limitation of the upper limbs due to the need for hand support while sitting. Surgical treatment aims to restore sitting balance, level the pelvis, improve trunk alignment, reduce pain caused by imbalance, and preserve or improve functional independence.
Conventional posterior spinal fusion can correct spinal deformity and pelvic obliquity but usually requires extensive posterior exposure and long-segment fusion, which may increase operative time, blood loss, transfusion volume, wound complications, intensive care unit admission, and hospitalization costs. A posterior minimally invasive correction technique using limited incisions and spinopelvic fixation may reduce surgical trauma while maintaining adequate deformity correction.
This is a prospective, single-center, randomized, parallel-group controlled trial. Eligible participants will be randomized in a 1:1 ratio to receive either posterior minimally invasive correction surgery or conventional posterior spinal fusion. Radiographic outcomes, including pelvic obliquity angle, coronal Cobb angle, regional kyphosis, and coronal balance, will be assessed preoperatively, postoperatively, and during follow-up. Perioperative outcomes, complications, reoperations, health-related quality of life, and medical costs will also be recorded.
The study protocol was approved by the institutional ethics committee before participant enrollment. The trial was registered after enrollment had begun because of an administrative oversight. No interim efficacy analysis was performed before trial registration.
- Being tested
- Posterior Minimally Invasive Correction Surgery, Conventional Posterior Spinal Fusion
- Keywords
- Posterior minimally invasive surgery, Posterior spinal fusion, Second sacral alar-iliac screw, S2AI screw, Pediatric spinal deformity, Spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Minimally Invasive Correction SurgeryProcedure or surgery
The posterior minimally invasive correction procedure is performed under general anesthesia with intraoperative neuromonitoring. Limited posterior incisions are made at the proximal thoracic region and the distal lumbosacral region. Proximal pedicle screw fixation and distal lumbosacral and pelvic fixation with second sacral alar-iliac screws are performed according to the planned construct. Precontoured rods are inserted through the incisions and passed subcutaneously or through a minimally invasive soft tissue tunnel, with connectors used as required. Deformity correction is performed to improve spinal alignment and pelvic obliquity. Limited fusion or bone grafting is performed at planned fixation areas according to the surgical protocol.
Conventional Posterior Spinal FusionProcedure or surgery
The conventional posterior spinal fusion procedure is performed under general anesthesia with intraoperative neuromonitoring. A standard long posterior midline incision is used to expose the planned instrumented segments. Pedicle screws and second sacral alar-iliac screws are inserted according to the surgical plan. Posterior release, deformity correction, rod placement, and bone grafting are performed according to standard open posterior spinal fusion techniques
| Study group | Role | What they receive |
|---|---|---|
| Posterior Minimally Invasive Correction Surgery | Experimental | Participants randomized to this arm will undergo posterior minimally invasive correction surgery using limited posterior incisions, posterior spinal instrumentation, and spinopelvic fixation with second sacral alar-iliac screws. The technique aims to correct scoliosis and pelvic obliquity while reducing soft tissue dissection and perioperative surgical trauma. Receives: Procedure: Posterior Minimally Invasive Correction Surgery |
| Conventional Posterior Spinal Fusion | Active comparator | Participants randomized to this arm will undergo conventional open posterior spinal fusion with long-segment posterior exposure, posterior spinal instrumentation, deformity correction, bone grafting, and spinopelvic fixation with second sacral alar-iliac screws according to standard surgical practice. Receives: Procedure: Conventional Posterior Spinal Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Obliquity Angle
Pelvic obliquity angle will be measured on sitting full-spine anteroposterior radiographs. The angle is defined as the angle between the line connecting the bilateral anterior superior iliac spines and the horizontal reference line. The primary outcome is the change in pelvic obliquity angle from baseline to 24 months after surgery.
Measured: Baseline, immediately after surgery and 24 months after surgery
Coronal Cobb Angle
The major coronal curve Cobb angle will be measured on sitting full-spine anteroposterior radiographs. The outcome is the change in Cobb angle from baseline to 24 months after surgery.
Measured: Baseline, immediately after surgery and 24 months after surgery
Coronal Balance
Coronal balance will be assessed as the horizontal distance between the C7 plumb line and the center sacral vertical line on sitting full-spine anteroposterior radiographs.
Measured: Baseline, immediately after surgery and 24 months after surgery
Surgical Complications
Complications including wound infection, pulmonary complications, neurological deterioration, implant malposition, implant loosening or failure, unplanned revision surgery, and other adverse events will be recorded.
Measured: From surgery to 24 months after surgery
Secondary outcomes (7)
Operative Time
Operative time will be recorded in minutes from skin incision to wound closure.
Measured: During surgery
Intraoperative Blood Loss
Estimated intraoperative blood loss will be recorded in milliliters according to the anesthesia and operative records.
Measured: During surgery
Intensive Care Unit Admission
The proportion of participants requiring postoperative admission to the intensive care unit will be recorded.
Measured: From the end of surgery to hospital discharge, up to 30 days
Length of Hospital Stay
Length of hospital stay will be recorded in days.
Measured: From admission to discharge, up to 60 days
Total Hospitalization Cost
Total hospitalization cost will be collected from the hospital billing system and recorded in Chinese yuan.
Measured: From admission to discharge, up to 60 days
Baseline and 24 months after surgery
Health-related quality of life will be assessed using the Chinese version of the Scoliosis Research Society-22 questionnaire. Domain scores and total score will be analyzed.
Measured: Baseline and 24 months after surgery
Reoperation Rate
The proportion of participants requiring unplanned reoperation related to the index spinal deformity surgery will be recorded.
Measured: From surgery to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start10 Aug 2024
- Primary completion9 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Paralytic ScoliosisStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Participants will be randomized in a 1:1 ratio to either posterior minimally invasive correction surgery or conventional posterior spinal fusion.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594574
- Sponsor's protocol ID
- 2024-JS-97
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the final publication may be shared upon reasonable request after publication. Shared data may include baseline characteristics, radiographic measurements, perioperative outcomes, complications, and patient-reported outcome scores. Data will be de-identified to protect participant privacy, particularly because the study involves pediatric participants with a rare condition.
Publications
Ishihara M, Taniguchi S, Kawashima K, Adachi T, Paku M, Tani Y, Ando M, Saito T. Bone Fusion Morphology after Circumferential Minimally Invasive Spine Surgery Using Lateral Lumbar Interbody Fusion and Percutaneous Pedicle Screws without Bone Grafting in the Thoracic Spine: A Retrospective Study. Medicina (Kaunas). 2022 Mar 30;58(4):496. doi: 10.3390/medicina58040496.
PubMed 35454335Cahill PJ, Marvil S, Cuddihy L, Schutt C, Idema J, Clements DH, Antonacci MD, Asghar J, Samdani AF, Betz RR. Autofusion in the immature spine treated with growing rods. Spine (Phila Pa 1976). 2010 Oct 15;35(22):E1199-203. doi: 10.1097/BRS.0b013e3181e21b50.
PubMed 20683383Rong T, Shen J, Wang Y, Li Z, Lin Y, Tan H, Feng E, Jiao Y. The Effect of Traditional Single Growing Rod Technique on the Growth of Unsegmented Levels in Mixed-Type Congenital Scoliosis. Global Spine J. 2022 Jun;12(5):922-930. doi: 10.1177/2192568220972080. Epub 2020 Nov 18.
PubMed 33203246Pei B, Lu D, Wu X, Xu Y, Ma C, Wu S. Effects of Growing Rod Technique with Different Surgical Modes and Growth Phases on the Treatment Outcome of Early Onset Scoliosis: A 3-D Finite Element Analysis. Int J Environ Res Public Health. 2022 Feb 12;19(4):2057. doi: 10.3390/ijerph19042057.
PubMed 35206246Modi HN, Suh SW, Fernandez H, Yang JH, Song HR. Accuracy and safety of pedicle screw placement in neuromuscular scoliosis with free-hand technique. Eur Spine J. 2008 Dec;17(12):1686-96. doi: 10.1007/s00586-008-0795-6. Epub 2008 Oct 1.
PubMed 18830636Wang Y, Zhu F, Zeng L, Wang S, Liu Y, Yang L, Zhao W, Zhou Y, Wu Z, Li M, Feng Y, Shen X, Guo X. Surfer Myelopathy in Children: A Case Series Study. World Neurosurg. 2021 Apr;148:e227-e241. doi: 10.1016/j.wneu.2020.12.135. Epub 2021 Jan 5.
PubMed 33418121Tong AN, Zhang JW, Zhou HJ, Tang HH, Bai JZ, Wang FY, Lv Z, Chen SZ, Liu SJ, Liu JS, Hong Y. Ischemic damage may play an important role in spinal cord injury during dancing. Spinal Cord. 2020 Dec;58(12):1310-1316. doi: 10.1038/s41393-020-0503-x. Epub 2020 Jun 19.
PubMed 32561846Holt JB, Dolan LA, Weinstein SL. Outcomes of Primary Posterior Spinal Fusion for Scoliosis in Spinal Muscular Atrophy: Clinical, Radiographic, and Pulmonary Outcomes and Complications. J Pediatr Orthop. 2017 Dec;37(8):e505-e511. doi: 10.1097/BPO.0000000000001049.
PubMed 28777284Hwang SW, Safain MG, King JJ, Kimball JS, Ames R, Betz RR, Cahill PJ, Samdani AF. Management of spinal cord injury-related scoliosis using pedicle screw-only constructs. J Neurosurg Spine. 2015 Feb;22(2):185-91. doi: 10.3171/2014.10.SPINE14185. Epub 2014 Nov 21.
PubMed 25415486Wolff S, Moreau PE, Miladi L, Riouallon G. Is Minimally Invasive Bipolar Technique a Better Alternative to Long Fusion for Adult Neuromuscular Scoliosis? Global Spine J. 2024 Sep;14(7):1909-1919. doi: 10.1177/21925682231159347. Epub 2023 Feb 21.
PubMed 36809191Ray WZ, Ravindra VM, Schmidt MH, Dailey AT. Stereotactic navigation with the O-arm for placement of S-2 alar iliac screws in pelvic lumbar fixation. J Neurosurg Spine. 2013 May;18(5):490-5. doi: 10.3171/2013.2.SPINE12813. Epub 2013 Mar 15.
PubMed 23495892Gaume M, Vergari C, Khouri N, Skalli W, Glorion C, Miladi L. Minimally Invasive Surgery for Neuromuscular Scoliosis: Results and Complications at a Minimal Follow-up of 5 Years. Spine (Phila Pa 1976). 2021 Dec 15;46(24):1696-1704. doi: 10.1097/BRS.0000000000004082.
PubMed 33907082Minimally invasive scoliosis surgery assisted by O-arm navigation for Lenke Type 5C adolescent idiopathic scoliosis: a comparison with standard open approach spinal instrumentation. J Neurosurg Pediatr. 2017 Apr;19(4):472-478. doi: 10.3171/2016.11.PEDS16412. Epub 2017 Feb 10.
PubMed 28186473de Bodman C, Miyanji F, Borner B, Zambelli PY, Racloz G, Dayer R. Minimally invasive surgery for adolescent idiopathic scoliosis: correction of deformity and peri-operative morbidity in 70 consecutive patients. Bone Joint J. 2017 Dec;99-B(12):1651-1657. doi: 10.1302/0301-620X.99B12.BJJ-2017-0022.R2.
PubMed 29212689Sun X, Xu L, Chen Z, Shi B, Chen X, Li S, Du C, Zhou Q, Qiu Y, Zhu Z. Hybrid Growing Rod Technique of Osteotomy With Short Fusion and Spinal Distraction: An Alternative Solution for Long-Spanned Congenital Scoliosis. Spine (Phila Pa 1976). 2019 May 15;44(10):707-714. doi: 10.1097/BRS.0000000000002933.
PubMed 30724828
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Minimally Invasive Surgery for Treating Paralytic Scoliosis With Pelvic Obliquity in Children Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07594574
- Acronym / sponsor ID
- 2024-JS-97
- Keywords
- Posterior minimally invasive surgery, Posterior spinal fusion, Second sacral alar-iliac screw, S2AI screw, Pediatric spinal deformity, Spinal cord injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 9 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 19 May 2026 (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 randomized controlled trial compares posterior minimally invasive correction surgery with conventional posterior spinal fusion for children with paralytic scoliosis and severe pelvic obliquity following spinal cord injury. Conventional posterior spinal fusion is widely used for severe neuromuscular or paralytic scoliosis but is associated with substantial surgical trauma, blood loss, transfusion requirements, and perioperative morbidity. The minimally invasive approach uses limited posterior incisions, posterior instrumentation, and spinopelvic fixation with second sacral alar-iliac screws. The study will evaluate whether minimally invasive surgery provides comparable correction of pelvic obliquity and spinal deformity while reducing perioperative surgical burden, complications, hospital stay, and medical costs.
Detailed description
Paralytic scoliosis following spinal cord injury in childhood is a specific subtype of neuromuscular scoliosis. Patients are often nonambulatory and may develop progressive long C-shaped thoracolumbar or lumbar curves, severe pelvic obliquity, impaired sitting balance, pain, hip dysplasia or subluxation, and functional limitation of the upper limbs due to the need for hand support while sitting. Surgical treatment aims to restore sitting balance, level the pelvis, improve trunk alignment, reduce pain caused by imbalance, and preserve or improve functional independence.
Conventional posterior spinal fusion can correct spinal deformity and pelvic obliquity but usually requires extensive posterior exposure and long-segment fusion, which may increase operative time, blood loss, transfusion volume, wound complications, intensive care unit admission, and hospitalization costs. A posterior minimally invasive correction technique using limited incisions and spinopelvic fixation may reduce surgical trauma while maintaining adequate deformity correction.
This is a prospective, single-center, randomized, parallel-group controlled trial. Eligible participants will be randomized in a 1:1 ratio to receive either posterior minimally invasive correction surgery or conventional posterior spinal fusion. Radiographic outcomes, including pelvic obliquity angle, coronal Cobb angle, regional kyphosis, and coronal balance, will be assessed preoperatively, postoperatively, and during follow-up. Perioperative outcomes, complications, reoperations, health-related quality of life, and medical costs will also be recorded.
The study protocol was approved by the institutional ethics committee before participant enrollment. The trial was registered after enrollment had begun because of an administrative oversight. No interim efficacy analysis was performed before trial registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either posterior minimally invasive correction surgery or conventional posterior spinal fusion.
| Arm | Type | Receives |
|---|---|---|
| Posterior Minimally Invasive Correction Surgery | Experimental | Procedure: Posterior Minimally Invasive Correction SurgeryParticipants randomized to this arm will undergo posterior minimally invasive correction surgery using limited posterior incisions, posterior spinal instrumentation, and spinopelvic fixation with second sacral alar-iliac screws. The technique aims to correct scoliosis and pelvic obliquity while reducing soft tissue dissection and perioperative surgical trauma. |
| Conventional Posterior Spinal Fusion | Active comparator | Procedure: Conventional Posterior Spinal FusionParticipants randomized to this arm will undergo conventional open posterior spinal fusion with long-segment posterior exposure, posterior spinal instrumentation, deformity correction, bone grafting, and spinopelvic fixation with second sacral alar-iliac screws according to standard surgical practice. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 6 to 20 years at the time of enrollment.
- Diagnosis of paralytic scoliosis secondary to spinal cord injury during childhood.
- Severe pelvic obliquity, defined as pelvic obliquity angle greater than 15 degrees on sitting full-spine anteroposterior radiographs.
- Major coronal scoliosis curve with Cobb angle greater than 40 degrees, or progressive deformity considered to require surgical correction by the treating spine deformity team.
- Nonambulatory status or severe lower-limb motor dysfunction after spinal cord injury.
Key exclusion criteria (9 listed)
- Idiopathic scoliosis, congenital scoliosis, syndromic scoliosis, or spinal deformity caused by etiologies other than spinal cord injury.
- Neuromuscular scoliosis caused by cerebral palsy, spinal muscular atrophy, muscular dystrophy, myelomeningocele, poliomyelitis, or other primary neuromuscular diseases.
- Previous spinal deformity correction surgery or previous long-segment spinal fusion.
- Active systemic infection or uncontrolled local infection at the planned surgical site.
- Severe pressure ulcer, osteomyelitis, or soft tissue condition that precludes safe posterior spinal surgery.
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 |
|---|---|---|
| Posterior Minimally Invasive Correction SurgeryThe posterior minimally invasive correction procedure is performed under general anesthesia with intraoperative neuromonitoring. Limited posterior incisions are made at the proximal thoracic region and the distal lumbosacral region. Proximal pedicle screw fixation and distal lumbosacral and pelvic fixation with second sacral alar-iliac screws are performed according to the planned construct. Precontoured rods are inserted through the incisions and passed subcutaneously or through a minimally invasive soft tissue tunnel, with connectors used as required. Deformity correction is performed to improve spinal alignment and pelvic obliquity. Limited fusion or bone grafting is performed at planned fixation areas according to the surgical protocol. | Procedure or surgery | Posterior Minimally Invasive Correction Surgery |
| Conventional Posterior Spinal FusionThe conventional posterior spinal fusion procedure is performed under general anesthesia with intraoperative neuromonitoring. A standard long posterior midline incision is used to expose the planned instrumented segments. Pedicle screws and second sacral alar-iliac screws are inserted according to the surgical plan. Posterior release, deformity correction, rod placement, and bone grafting are performed according to standard open posterior spinal fusion techniques | Procedure or surgery | Conventional Posterior Spinal Fusion |
Primary outcome
Pelvic Obliquity Angle
Time frame: Baseline, immediately after surgery and 24 months after surgery
Pelvic obliquity angle will be measured on sitting full-spine anteroposterior radiographs. The angle is defined as the angle between the line connecting the bilateral anterior superior iliac spines and the horizontal reference line. The primary outcome is the change in pelvic obliquity angle from baseline to 24 months after surgery.
Coronal Cobb Angle
Time frame: Baseline, immediately after surgery and 24 months after surgery
The major coronal curve Cobb angle will be measured on sitting full-spine anteroposterior radiographs. The outcome is the change in Cobb angle from baseline to 24 months after surgery.
Coronal Balance
Time frame: Baseline, immediately after surgery and 24 months after surgery
Coronal balance will be assessed as the horizontal distance between the C7 plumb line and the center sacral vertical line on sitting full-spine anteroposterior radiographs.
Surgical Complications
Time frame: From surgery to 24 months after surgery
Complications including wound infection, pulmonary complications, neurological deterioration, implant malposition, implant loosening or failure, unplanned revision surgery, and other adverse events will be recorded.
7 secondary outcomes
Operative Time
Time frame: During surgery
Intraoperative Blood Loss
Time frame: During surgery
Intensive Care Unit Admission
Time frame: From the end of surgery to hospital discharge, up to 30 days
Length of Hospital Stay
Time frame: From admission to discharge, up to 60 days
Total Hospitalization Cost
Time frame: From admission to discharge, up to 60 days
Baseline and 24 months after surgery
Time frame: Baseline and 24 months after surgery
Reoperation Rate
Time frame: From surgery to 24 months after surgery
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 19 May 2026.
- Background: PubMed 35454335Ishihara M, Taniguchi S, Kawashima K, Adachi T, Paku M, Tani Y, Ando M, Saito T. Bone Fusion Morphology after Circumferential Minimally Invasive Spine Surgery Using Lateral Lumbar Interbody Fusion and Percutaneous Pedicle Screws without Bone Grafting in the Thoracic Spine: A Retrospective Study. Medicina (Kaunas). 2022 Mar 30;58(4):496. doi: 10.3390/medicina58040496.
- Background: PubMed 20683383Cahill PJ, Marvil S, Cuddihy L, Schutt C, Idema J, Clements DH, Antonacci MD, Asghar J, Samdani AF, Betz RR. Autofusion in the immature spine treated with growing rods. Spine (Phila Pa 1976). 2010 Oct 15;35(22):E1199-203. doi: 10.1097/BRS.0b013e3181e21b50.
- Background: PubMed 33203246Rong T, Shen J, Wang Y, Li Z, Lin Y, Tan H, Feng E, Jiao Y. The Effect of Traditional Single Growing Rod Technique on the Growth of Unsegmented Levels in Mixed-Type Congenital Scoliosis. Global Spine J. 2022 Jun;12(5):922-930. doi: 10.1177/2192568220972080. Epub 2020 Nov 18.
- Background: PubMed 35206246Pei B, Lu D, Wu X, Xu Y, Ma C, Wu S. Effects of Growing Rod Technique with Different Surgical Modes and Growth Phases on the Treatment Outcome of Early Onset Scoliosis: A 3-D Finite Element Analysis. Int J Environ Res Public Health. 2022 Feb 12;19(4):2057. doi: 10.3390/ijerph19042057.
- Background: PubMed 18830636Modi HN, Suh SW, Fernandez H, Yang JH, Song HR. Accuracy and safety of pedicle screw placement in neuromuscular scoliosis with free-hand technique. Eur Spine J. 2008 Dec;17(12):1686-96. doi: 10.1007/s00586-008-0795-6. Epub 2008 Oct 1.
- Background: PubMed 33418121Wang Y, Zhu F, Zeng L, Wang S, Liu Y, Yang L, Zhao W, Zhou Y, Wu Z, Li M, Feng Y, Shen X, Guo X. Surfer Myelopathy in Children: A Case Series Study. World Neurosurg. 2021 Apr;148:e227-e241. doi: 10.1016/j.wneu.2020.12.135. Epub 2021 Jan 5.
- Background: PubMed 32561846Tong AN, Zhang JW, Zhou HJ, Tang HH, Bai JZ, Wang FY, Lv Z, Chen SZ, Liu SJ, Liu JS, Hong Y. Ischemic damage may play an important role in spinal cord injury during dancing. Spinal Cord. 2020 Dec;58(12):1310-1316. doi: 10.1038/s41393-020-0503-x. Epub 2020 Jun 19.
- Background: PubMed 28777284Holt JB, Dolan LA, Weinstein SL. Outcomes of Primary Posterior Spinal Fusion for Scoliosis in Spinal Muscular Atrophy: Clinical, Radiographic, and Pulmonary Outcomes and Complications. J Pediatr Orthop. 2017 Dec;37(8):e505-e511. doi: 10.1097/BPO.0000000000001049.
- Background: PubMed 25415486Hwang SW, Safain MG, King JJ, Kimball JS, Ames R, Betz RR, Cahill PJ, Samdani AF. Management of spinal cord injury-related scoliosis using pedicle screw-only constructs. J Neurosurg Spine. 2015 Feb;22(2):185-91. doi: 10.3171/2014.10.SPINE14185. Epub 2014 Nov 21.
- Background: PubMed 36809191Wolff S, Moreau PE, Miladi L, Riouallon G. Is Minimally Invasive Bipolar Technique a Better Alternative to Long Fusion for Adult Neuromuscular Scoliosis? Global Spine J. 2024 Sep;14(7):1909-1919. doi: 10.1177/21925682231159347. Epub 2023 Feb 21.
- Background: PubMed 23495892Ray WZ, Ravindra VM, Schmidt MH, Dailey AT. Stereotactic navigation with the O-arm for placement of S-2 alar iliac screws in pelvic lumbar fixation. J Neurosurg Spine. 2013 May;18(5):490-5. doi: 10.3171/2013.2.SPINE12813. Epub 2013 Mar 15.
- Background: PubMed 33907082Gaume M, Vergari C, Khouri N, Skalli W, Glorion C, Miladi L. Minimally Invasive Surgery for Neuromuscular Scoliosis: Results and Complications at a Minimal Follow-up of 5 Years. Spine (Phila Pa 1976). 2021 Dec 15;46(24):1696-1704. doi: 10.1097/BRS.0000000000004082.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the final publication may be shared upon reasonable request after publication. Shared data may include baseline characteristics, radiographic measurements, perioperative outcomes, complications, and patient-reported outcome scores. Data will be de-identified to protect participant privacy, particularly because the study involves pediatric participants with a rare condition.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Minimally Invasive Correction Surgery and Conventional Posterior Spinal Fusion in people with Paralytic Scoliosis and Pelvic Obliquity, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Obliquity Angle (time frame: Baseline, immediately after surgery and 24 months after surgery). The study lists 4 primary outcomes in all. 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 NCT07594574, which also lists 25 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 19 May 2026.