Hybrid Construct Versus Pedicle Screw-only System for the Treatment Scoliosis

Completed

• Conditions: Scoliosis Idiopathic; Dysplastic
• Interventions: Procedure: implantation of the hybrid instrumentation system

• Registration Number: NCT06500195
• Lead Sponsor: Pomeranian Medical University Szczecin

Brief Summary

The placement of pedicular screws in spinal surgery has become the gold standard for scoliosis treatment. However, the use of sublaminar bands (SBs) on the apex of the curvature in idiopathic scoliosis (AIS) lowers the risk of neurological complications related to incorrect implementation of transpedicular screws into dysplastic pedicles without a cancellous channel. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used.

Detailed Description

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformation of the spine. The goal of the treatment is to achieve a reduction in deformity, restoring proper alignment and the best possible function of the spine. Pedicular screw placement in spinal surgery has become the gold standard for scoliosis reduction techniques in the last 30 years \[6\]. The screw-only systems are relatively safe, as various authors have proven. However, if implemented incorrectly, the screws increase the risk of damage to nervous or vascular structures and internal organs. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used. The inclusion criteria were this being the patients' first scoliosis operation due to AIS (Lenke type 1) and age under 18 years. The primary measured outcome involved correction efficacy, defined as the Cobb score baseline to endpoint change.

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-09-30
• Study Completion: 2024-01-02
• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• idiopathic scoliosis (AIS)
• Lenke type 1

Exclusion Criteria

• AIS other than Lenke type 1 (neurogenic, congenial, or syndromic curvatures)
• abnormalities in the structure of the central nervous system in the MRI image
• advanced chronic respiratory or circulatory failure
• emergency surgery
• reoperation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HYBRID	implantation of the hybrid instrumentation system	The HYBRID group of patients whose corrections were performed using the hybrid instrumentation system (screws and bands).

Primary Outcome Measures

Name	Time	Method
correction efficacy	at the 3rd day after the surgery procedure	defined as the Cobb score baseline to endpoint change (Cobb angle change in the operated spine segment in % at endpoint: X-ray imaging was performed (AP and lateral)

Secondary Outcome Measures

Name	Time	Method
length of surgery procedure	procedure (from skin incision to skin suture)	duration of the hospitalization measured in minutes

Trial Locations

Locations (1)

Pomeranian Medical University; 🇵🇱 Szczecin, Poland