Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500195
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-07-02
Brief Title:
Hybrid Construct Versus Pedicle Screw-only System for the Treatment Scoliosis
Sponsor:
Pomeranian Medical University Szczecin
Organization:
Pomeranian Medical University Szczecin
Study Overview
Official Title:
Cobb Angle Comparison of Hybrid Construct Versus Pedicle Screw-only System for the Treatment of Lenke 1 Adolescent Idiopathic Scoliosis
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hypoplasticaplastic 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 hypoplasticaplastic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None