Rod Shape Changing After Scoliosis Correction Surgery

NCT05033171 | Completed

• 1 other identifier: UP-CC-Ortho-RodShape
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The change of the fixation-rod after posterior srew-rod fixation segmentdesis is not widely known. The recent development of the 3D scanning technics and the opportunities of the EOS 2D/3D system made us possible to have the exact rod shape immediately after implantation, and at each control examination. These progressions made us available to follow up the shape changing of the fixation-rod, hereby the changing of the correction.

Conditions

Scoliosis Idiopathic; Scoliosis, Severe

Keywords

scoliosis; posterior segmentdesis; 3D scanning; EOS 2D/3D

Outcome Measures

Primary Outcomes (1)

• Shape changing of the rod

  The fitted 3D models of the implanted rod right after implantation, 3 day, than 3-6-12-24 months after the surgery

  2 years

Study Arms (1)

Study group

EXPERIMENTAL

Patients with scoliosis induced surgical indication (Cobb-degree\>45). * Posterior screw-rod fixation segmentdesis * Before the implantation, right after the implantation and after the in situ bending 3D scanning of the rod using Artec Eva Spider type manual 3D scanner will be performed. Scanning is possible from a more than 60 cm distance, so that means the operational area stays sterile. * EOS Micro Dose imaging will be done on the third day after surgery, on the third, the sixth, the twelfth and twenty fourth month after surgery (as in the actual clinical protocal).

Diagnostic Test: 3D Scanning; Diagnostic Test: EOS 2D/3D scanning

Interventions

3D Scanning DIAGNOSTIC_TEST

3D scanning of the rod using Artec Eva Spider type manual 3D scanner

Study group

EOS 2D/3D scanning DIAGNOSTIC_TEST

EOS Micro Dose imaging will be done on the third day after surgery, on the third, the sixth, the twelfth and twenty fourth month after surgery.

Study group

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• routine patient care of University of Pécs Medical School Department of Orthopaedics
• diagnosed idiopathic adolescent scoliosis
• scoliosis induced surgical indication (Cobb-degree\>45)

You may not qualify if:

• early onset or adult degenerative scoliosis
• scoliosis with known origin
• the angle of the curve does not reach the criteria of surgical indication (Cobb-degree\<45)
• former spine surgery

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Ádám Schlégl

Pécs, Baranya, 7632, Hungary

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Peter Than, PhD

  UP MS Department of Orthopaedics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 2, 2021
• Study Start: September 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)