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

NCT06279468 | Recruiting DMC

• 1 other identifier: I-23PJ2232
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intervertebral disc release; Adolescent idiopathic scoliosis; Derotation

Outcome Measures

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.

  immediately before surgery and one week after the surgery

Secondary Outcomes (23)

• Lumbar curve

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

• UIV tilt

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

• C7-CSVL

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

• Lumbar lordosis

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

• SVA

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

Study Arms (2)

IDR group

EXPERIMENTAL

A group designated as the IDR group will undergo subsequent intervertebral disc release following Ponte osteotomy on the predetermined vertebral levels.

Procedure: intervertebral disc release

PO group

ACTIVE COMPARATOR

The PO group will solely undergo Ponte osteotomy.

Procedure: Ponte osteotomy

Interventions

intervertebral disc release PROCEDURE

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.

Also known as: IDR

IDR group

Ponte osteotomy PROCEDURE

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

Also known as: PO

PO group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 10 and 18
• American Society of Anesthesiologists (ASA) physical statusclassification of I-II
• Lenke 5 type adolescent idiopathic scoliosis

You may not qualify if:

• A history of previous corrective surgery
• With sharp, angulated short-segmental scoliosis
• With congenital scoliosis requiring 3-column osteotomy

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100035, China

RECRUITING

Study Officials

• Qianyu Zhuang, Professor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianyu Zhuang, Professor

CONTACT

+86 15200838996; baizhuosong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 28, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)