MRI-Guided Dynamic Support System for Scoliosis Correction

MRI-Guided Dynamic Support System for Scoliosis Correction (MRI-DSS)

This prospective pilot study evaluates the feasibility and effectiveness of an MRI-guided dynamic support system (MRI-DSS) for rapid, quantitative correction of adolescent idiopathic scoliosis (AIS). The system uses MRI-compatible air padding supports and programmable pneumatic control to apply and adjust corrective forces in real time. AIS patients underwent MRI-guided bracing, with Cobb angles and biomechanical parameters measured at each pressure level.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Device: MRI-guided Dynamic Support System

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raymond Tong, PhD; Phone Number: 39438454; Email: kytong@cuhk.edu.hk
• Study Contact Backup: Name: Joanne Yip, PhD; Phone Number: 27664848; Email: joanne.yip@polyu.edu.hk

Study Locations

• Hong Kong
  • Kowloon
    • Tsim Sha Tsui, Kowloon, Hong Kong
      • Recruiting
      • The Hong Kong Polytechnic University
      • Contact: Joanne Yip, PhD; Phone Number: 27664848

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 10-16 years
• Diagnosis: Adolescent idiopathic scoliosis (Cobb angle 10-25°)
• No prior spinal surgery or other orthopedic conditions
• Able to provide informed consent
• Risser sign 0-5

Exclusion Criteria:

• Age <10 or >16 years
• Cobb angle <10° or >25°
• History of spinal surgery or other spine disorders
• Contraindications to MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIS bracing group; Moderate AIS patients wearing customized MRI compatible soft brace, supine position lie in the MRI device	Device: MRI-guided Dynamic Support System; MRI-compatible pneumatic support system with customized padding inserted into the brace, used for image-guided adjustment of corrective pressure during MRI scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cobb angle	degrees measured by MRI	baseline
Time to achieve target correction	measured in minutes	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact area and force distribution	measured by 3D MRI reconstruction	immediately after the intervention

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Raymond Tong, PhD, Chinese University of Hong Kong; Principal Investigator: Joanne Yip, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Scoliosis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: HSEARS20230614001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No