Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorPeking Union Medical College Hospital

About this trial

Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the ages of 10 and 18

American Society of Anesthesiologists (ASA) physical statusclassification of I-II

Lenke 5 type adolescent idiopathic scoliosis

Disqualifiers

A history of previous corrective surgery

With sharp, angulated short-segmental scoliosis

With congenital scoliosis requiring 3-column osteotomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • intervertebral disc release

    Procedure/Surgery

    After standard posterior instrumentation and fusion in scoliosis cases, Ponte osteotomies are performed on vertebrae with a Nash-Moe classification of 1 degree or higher. The intervertebral discs on the convex side of the scoliosis, situated between the vertebrae that have undergone Ponte osteotomy, will be approached and incised parallel to the intervertebral space. The intervertebral disc and endplate cartilage were incised and separated using reamers. Subsequently, the intervertebral space was expanded and irrigated, and the fragments of the intervertebral disc were extracted using nucleus pulposus forceps. Impacting bone graft into the intervertebral space, thus sustaining the optimal height of intervertebral space.

  • Ponte osteotomy

    Procedure/Surgery

    After standard posterior instrumentation and fusion in scoliosis cases, Ponte osteotomies are performed on vertebrae with a Nash-Moe classification of 1 degree or higher. Subsequent corrective procedures can be performed immediately following Ponte osteotomy completion. The deformity was corrected using the bilateral rod rotation and segmental derotation technique after inserting rods. Under fluoroscopic guidance, compression, distraction, and in situ bending maneuvers were implemented as needed. Allograft bone material was utilized for the purpose of bone fusion

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: IDR groupExperimental treatment 1 intervention
Group B: PO groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The correction rate of axial rotation of the apex vertebrae

Axial rotation of apex vertebrae will be measured before and one week after the surgery using a novel computer-based automated measurement algorithm applied to computed tomography (CT) images. The algorithm used is a symmetry ratio algorithm that eliminates the need for manual landmark selection. It operates on the premise that the axis of maximum symmetry in a vertebral cross-section determines the angular orientation of the vertebra.

Time frame
immediately before surgery and one week after the surgery

Secondary outcomes

1

Lumbar curve

the cobb angle of the lumbar curve

Time frame
immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up
2

UIV tilt

the angle between the endplate of upper instrumented vertebra and the horizontal line

Time frame
immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up
3

C7-CSVL

Radiographic parameters measured by CT scan: the distance between C7 vertebra and Central Sacral Vertical Line (CSVL)

Time frame
immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up
4

Lumbar lordosis

the cobb angle of lumbar lordosis on sagittal plane

Time frame
immediately before surgery, 1-week post surgery, 3-month, 6-month, 1-year, 2-year, and 3-year follow-up

Other outcomes

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