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

Summary

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.

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

PROCEDURE

intervertebral disc release

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.

PROCEDURE

Ponte osteotomy

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

Sponsors & Collaborators

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Qianyu Zhuang, Professor · Peking Union Medical College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2026-09-01

Completion

2026-09-01

Countries

• China

Study Locations