Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516497
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
Use of Motion Sensors in Correction Procedures of Long Bone Deformities in the Pediatric Age Group
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Motion Sensors in Correction Procedures of Long Bone Deformities in the Pediatric Age Group
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Patients who are between the ages of 2 and 18 who are admitted to Atatürk University Faculty of Medicine Research Hospital who are considered to have long bone deformities in their lower extremities and who have gait disorders and who have not previously undergone lower extremity surgery will be included in the study To determine the degree of preoperative deformity of these patients a physical examination will be performed after gait analysis and foot advancement angles hip rotation degrees thigh foot angles transmalleolar axis angles and forefoot alignment will be determined and recorded Following the routine preoperative computerized tomography performed on the patients long bone alignment disorders joint incompatibilities valgus varus deformities femoral anteversion femoral retroversion tibial torsion angles will be determined quantitatively and the amount of deformity correction to be performed in the surgery will be determined before the surgery and the quantitative values will be recorded After two wires are placed in the same plane from the proximal and distal parts of the determined osteotomy line motion sensors will be placed on the long bones of the anesthetized patients during the surgery Osteotomy will be performed on the bone with deformity from the deformity center When correcting the degree of deformity fixation with plate and screws will be performed after the correction is achieved by the amount of deformity determined preoperatively In other countries and in our country approximate correction is provided without quantitative data Although the preoperative degree of deformity can be determined quantitatively surgery is performed by determining the degree of correction intraoperatively by eye decision Thanks to the sensors and application exactly how many degrees of deformity will be corrected will be determined 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None