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

Cobb Angle Comparison of Hybrid Construct Versus Pedicle Screw-only System for the Treatment of Lenke 1 Adolescent Idiopathic Scoliosis

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis Idiopathic; Dysplastic
• Intervention / Treatment: Procedure: implantation of the hybrid instrumentation system

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Poland
  • Szczecin, Poland, 71-252
    • Pomeranian Medical University

Participation Criteria

Eligibility Criteria

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

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Surgery corrections were performed using the hybrid instrumentation system (screws and bands).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of surgery procedure	duration of the hospitalization measured in minutes	procedure (from skin incision to skin suture)

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: KB.006.112.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: after personal request

Drug and device information, study documents

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