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Rod Shape Changing After Scoliosis Correction Surgery

Primary Purpose

Scoliosis Idiopathic, Scoliosis, Severe

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
3D Scanning
EOS 2D/3D scanning
Sponsored by
University of Pecs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring scoliosis, posterior segmentdesis, 3D scanning, EOS 2D/3D

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ádám Schlégl

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2021
Last Updated
March 21, 2023
Sponsor
University of Pecs
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1. Study Identification

Unique Protocol Identification Number
NCT05033171
Brief Title
Rod Shape Changing After Scoliosis Correction Surgery
Official Title
The Changing of the Fixation-rod Shape After Posterior Correction Segmentdesis in Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pecs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic, Scoliosis, Severe
Keywords
scoliosis, posterior segmentdesis, 3D scanning, EOS 2D/3D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
3D Scanning
Intervention Description
3D scanning of the rod using Artec Eva Spider type manual 3D scanner
Intervention Type
Diagnostic Test
Intervention Name(s)
EOS 2D/3D scanning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Shape changing of the rod
Description
The fitted 3D models of the implanted rod right after implantation, 3 day, than 3-6-12-24 months after the surgery
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Than, PhD
Organizational Affiliation
UP MS Department of Orthopaedics
Official's Role
Study Chair
Facility Information:
Facility Name
Ádám Schlégl
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7632
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

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Rod Shape Changing After Scoliosis Correction Surgery

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