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

NCT06500195 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-07-15

No results posted yet for this study

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.

Conditions

  • Scoliosis Idiopathic
  • Dysplastic

Interventions

PROCEDURE

implantation of the hybrid instrumentation system

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

Sponsors & Collaborators

  • Pomeranian Medical University Szczecin

    lead OTHER

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-09-30
Completion
2024-01-02

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06500195 on ClinicalTrials.gov