Rod Shape Changing After Scoliosis Correction Surgery

Scoliosis Idiopathic Clinical Trial

Official title:

The Changing of the Fixation-rod Shape After Posterior Correction Segmentdesis in Adolescent Idiopathic Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05033171
• Other study ID #: UP-CC-Ortho-RodShape
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The adolescent idiopathic scoliosis can affect the 0,5-2% of the European population. One of the widely accepted treatment of severe scoliosis (Cobb angle is over 40-50°, or more than 10° progression observed a year) is posterior correction segmentdesis with screw and rod instrumentation. As a scoliosis treatment center, about 90-110 scoliosis correction surgeries are performed in our department, using conventional preoperative planning, coronal and sagittal translation technique from posterolateral approach.

An EOS 2D/3D system is available in our department making possible the scanning of the patient with upright biplanar ultra-low dose x-rays technique. The SterEOS software makes us possible to reconstruct the surface of the spine, pelvis and lower limb. The biplanar modality of the images makes possible to 3D reconstruct any simple shape using CAD (computer-aided design) softwares.

The recent updates in the 3D scanning technology also made us possible to perform intraoperative scannings without harming the sterility.

The aim of the study to define the change of the fixation-rod's shape after scoliosis correction surgery.

Main hypothesis: there is significant change in the rod shape after implantation

Secondary hypothesis 1: during the implant of the rod, it will loose from the prebent correction depending of the severity and rigidity of the curve.

Secondary hypothesis 2: in the early stage of the rehabilitation, after the mobilization the shape of the rod (and the spinal parameters) can change Secondary hypothesis 3: after the 3. month postoperatively the shape of rod does not change anymore

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

Inclusion Criteria:

• routine patient care of University of Pécs Medical School Department of Orthopaedics

• diagnosed idiopathic adolescent scoliosis

• scoliosis induced surgical indication (Cobb-degree>45)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

Intervention

Diagnostic Test:
• 3D Scanning
3D scanning of the rod using Artec Eva Spider type manual 3D scanner
• EOS 2D/3D scanning
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.

Locations

Country	Name	City	State
Hungary	Ádám Schlégl	Pécs	Baranya

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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