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

NCT06500195 | Completed

• 1 other identifier: KB.006.112.2023
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic; Dysplastic

Outcome Measures

Primary Outcomes (1)

• correction efficacy

  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)

  at the 3rd day after the surgery procedure

Secondary Outcomes (1)

• length of surgery procedure

  procedure (from skin incision to skin suture)

Study Arms (2)

SCREWS

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

HYBRID

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

Procedure: implantation of the hybrid instrumentation system

Interventions

implantation of the hybrid instrumentation system PROCEDURE

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

HYBRID

Eligibility Criteria

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

Study Population

Patients who qualified for scoliosis surgery in this center underwent X-ray imaging (AP, lateral, lateral bending view), computed tomography, and magnetic resonance imaging. Patients with a Cobb angle greater than 45 degrees (or 40 degrees in highly progressive cases) were considered eligible for the study. Based on the computed tomography assessment that was performed prior to the surgery, patients were assigned to one of two groups depending on the pedicle type on the apex of the thoracic curvature according to Watanabe pedicle's classification.

You may qualify if:

• idiopathic scoliosis (AIS)
• Lenke type 1

You may not qualify if:

• 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

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Pomeranian Medical University

Szczecin, 71-252, Poland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 15, 2024
• Study Start: December 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: January 2, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

PL (1)