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Rod Shape Changing After Scoliosis Correction Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05033171
Enrollment
10
Registered
2021-09-02
Start date
2019-09-01
Completion date
2022-12-31
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis Idiopathic, Scoliosis, Severe

Keywords

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

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

Interventions

DIAGNOSTIC_TEST3D Scanning

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

DIAGNOSTIC_TESTEOS 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.

Sponsors

University of Pecs
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Shape changing of the rod2 yearsThe fitted 3D models of the implanted rod right after implantation, 3 day, than 3-6-12-24 months after the surgery

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026