Use of Motion Sensors in Correction Procedures of Long Bone Deformities in the Pediatric Age Group

NCT06516497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-31

No results posted yet for this study

Summary

Motion sensors will be used in long bone deformity surgery in pediatric patients.

In patients whose deformity status is determined before the surgery, 2 wires will be placed in the same plane from the proximal and distal of the determined osteotomy line to the long bones of the patients who are anesthetized during the surgery and motion sensors will be placed on the wires. Osteotomy will be performed on the bone with deformity from the deformity center. While correcting the degree of deformity, fixation with plate and screws will be performed after the amount of correction determined preoperatively is achieved. Thanks to the sensors and application, it will be determined exactly how many degrees of deformity will be corrected in the case. At the same time, multiplanar and difficult-to-detect deformities will be corrected almost ideally with the help of motion and acceleration sensors. Approximately at the 6th week after the case, deformity correction status will be recorded again with gait analysis and physical examination following the removal of the cast, splint and bone healing. The results will be compared after the traditional method and the method using sensors are performed with an equal number of patients. As a result, it is aimed to clearly correct the deformity quantitatively and shorten the surgical time.

Conditions

  • Angulation Deformity of Long Bone (Disorder)
  • Acquired Deformity of Knee Joint (Disorder)

Interventions

OTHER

Group using traditional method in long bone deformity correction

Osteotomy will be performed from the deformity center after two coring wires are placed in the same plane from the proximal and distal of the determined osteotomy line to the femur or tibia of the patients in the control group with deformity. While the degree of deformity is corrected, the determination will be made after the amount of deformity determined preoperatively is determined visually.

DEVICE

Group using computer-aided sensors in long bone deformity correction

After 2 wires are placed in the same plane from the proximal and distal parts of the osteotomy line determined on the deformed femur or tibia of patients who underwent general anesthesia during the surgery, motion sensors will be placed on the wires. Osteotomy will be performed on the bone with deformity from the deformity center. When correcting the degree of deformity, the detection will be performed after the correction is achieved by the amount of deformity determined preoperatively.

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-05
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516497 on ClinicalTrials.gov