Angulation Deformity of Long Bone (Disorder)NCT06516497
Use of Motion Sensors in Correction Procedures of Long Bone Deformities in the Pediatric Age Group
A study testing Group using traditional method in long bone deformity correction and Group using computer-aided sensors in long bone deformity correction in people with Angulation Deformity of Long Bone (Disorder) and Acquired Deformity of Knee Joint (Disorder), run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Angulation Deformity of Long Bone (Disorder), Acquired Deformity of Knee Joint (Disorder)
- What is being tested?
- Group using traditional method in long bone deformity correction and Group using computer-aided sensors in long bone deformity correction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of long bone deformity
- Must be between the ages of 2 and 18 when applying for deformity correction.
Who cannot join
- Patients or their parents do not accept surgical treatment
- Not being between the ages of 2 and 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Group using traditional method in long bone deformity correction, Group using computer-aided sensors in long bone deformity correction
- Keywords
- pediatric orthopedics, Deformities, Motion sensor
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group using traditional method in long bone deformity correctionOther
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.
Group using computer-aided sensors in long bone deformity correctionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group using traditional method in long bone deformity correction | Experimental | 20 people between the ages of 2-18. Pediatric patients with long bone deformities and surgical indications. When correcting the deformity in these patients, the current method in deformity surgery all over the world is roughly corrected and the decision is made according to clinical experience. Receives: Other: Group using traditional method in long bone deformity correction |
| Group using computer-aided sensors in long bone deformity correction | Experimental | 20 people between the ages of 2-18. Pediatric patients with long bone deformities and surgical indications. A sensor designed together with engineers will be used to correct the deformity in these patients. Receives: Device: Group using computer-aided sensors in long bone deformity correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring preoperative deformity angles
A preoperative clinical examination will be performed in pediatric orthopedic deformity patients, especially in patients who lean in, lean out, or cannot fully extend their knees. During the clinical examination, measurements will be made with a goniometer or on a computer by taking photographs. For rotational deformities in the transverse plane, the foot advancement angle, femoral internal and external rotation angles, and transmalleolar axis angle will be measured and noted. In patients with extension limitation, the degree of limitation will be measured by goniometer or conventional radiographs. The amount of deformity will be determined exactly and the surgery will be performed.
Measured: 2 months
measuring postoperative deformity angles
The amount of deformity corrected after surgery will be measured and noted by clinical examination and conventional x-rays 2 months later, after the child has recovered.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start5 May 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angulation Deformity of Long Bone (Disorder)Studies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Cagatay Engin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516497
- Sponsor's protocol ID
- 536
- Status last verified
- Dec 2024
- First submitted
- 13 Jul 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Motion Sensors in Correction Procedures of Long Bone Deformities in the Pediatric Age Group
- ClinicalTrials.gov ID
- NCT06516497
- Acronym / sponsor ID
- 536
- Keywords
- pediatric orthopedics, Deformities, Motion sensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group using traditional method in long bone deformity correction | Experimental | Other: Group using traditional method in long bone deformity correction20 people between the ages of 2-18. Pediatric patients with long bone deformities and surgical indications. When correcting the deformity in these patients, the current method in deformity surgery all over the world is roughly corrected and the decision is made according to clinical experience. |
| Group using computer-aided sensors in long bone deformity correction | Experimental | Device: Group using computer-aided sensors in long bone deformity correction20 people between the ages of 2-18. Pediatric patients with long bone deformities and surgical indications. A sensor designed together with engineers will be used to correct the deformity in these patients. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Presence of long bone deformity
- Must be between the ages of 2 and 18 when applying for deformity correction.
Key exclusion criteria (2 listed)
- Patients or their parents do not accept surgical treatment
- Not being between the ages of 2 and 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group using traditional method in long bone deformity correctionOsteotomy 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. | Other | Group using traditional method in long bone deformity correction |
| Group using computer-aided sensors in long bone deformity correctionAfter 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. | Device | Group using computer-aided sensors in long bone deformity correction |
Primary outcome
measuring preoperative deformity angles
Time frame: 2 months
A preoperative clinical examination will be performed in pediatric orthopedic deformity patients, especially in patients who lean in, lean out, or cannot fully extend their knees. During the clinical examination, measurements will be made with a goniometer or on a computer by taking photographs. For rotational deformities in the transverse plane, the foot advancement angle, femoral internal and external rotation angles, and transmalleolar axis angle will be measured and noted. In patients with extension limitation, the degree of limitation will be measured by goniometer or conventional radiographs. The amount of deformity will be determined exactly and the surgery will be performed.
measuring postoperative deformity angles
Time frame: 2 months
The amount of deformity corrected after surgery will be measured and noted by clinical examination and conventional x-rays 2 months later, after the child has recovered.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group using traditional method in long bone deformity correction and Group using computer-aided sensors in long bone deformity correction in people with Angulation Deformity of Long Bone (Disorder) and Acquired Deformity of Knee Joint (Disorder), run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring preoperative deformity angles (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.