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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-01-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Scoliosis Idiopathic Dysplastic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SCREWS

The SCREWS group of patients operated on with the use of only transpedicular screws.

No interventions assigned to this group

HYBRID

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

implantation of the hybrid instrumentation system

Intervention Type PROCEDURE

Surgery corrections were performed using the hybrid instrumentation system (screws and bands).

Interventions

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implantation of the hybrid instrumentation system

Surgery corrections were performed using the hybrid instrumentation system (screws and bands).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No