- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251961
The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
February 22, 2022 updated by: Abdelmajeed Aboelabaas Abdelmajeed, Sohag University
The objective of this study is to evaluate the value of growing rods for the correction of long bone deformities in pediatric cases attending Sohag University Hospital and follow up aiming at determining benefits and obstacles to this technique
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
- The participants will be subjected to surgical correction using growing rods as a novel technique for their long bone deformities.
- Procedure will be done under anaesethia
- Osteotomy , fracture reduction , deformity correction will be done , then introduction of the growing rod
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abdelmageed Aboelabbas
- Phone Number: 00201002711810
- Email: abdelmageed.ortho87@yahoo.com
Study Contact Backup
- Name: Ahmad Addosooki
- Phone Number: 00201011110232
- Email: addosooki@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- cases of osteogenesis imperfecta
- metabolic bone deformities
- cases of hemimelia
- traumatic bone deformities
- complex or simple deformities
Exclusion Criteria:
- adult deformities
- short bone deformities
- very narrow medulla
- osteopetrosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
Time Frame: 2 years
|
- Evaluation of deformity angles correction after use of growing rods in comparison with preoperative angle
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sarikaya I, Seker A, Erdal OA, Gunay H, Inan M, Guler B. Using a corkscrew-tipped telescopic nail in the treatment of osteogenesis imperfecta: a biomechanical study and preliminary results of 17 consecutive cases. J Pediatr Orthop B. 2019 Mar;28(2):173-178. doi: 10.1097/BPB.0000000000000537.
- Persiani P, Ranaldi FM, Martini L, Zambrano A, Celli M, D'Eufemia P, Villani C. Treatment of tibial deformities with the Fassier-Duval telescopic nail and minimally invasive percutaneous osteotomies in patients with osteogenesis imperfecta type III. J Pediatr Orthop B. 2019 Mar;28(2):179-185. doi: 10.1097/BPB.0000000000000536.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2022
Primary Completion (Anticipated)
April 30, 2024
Study Completion (Anticipated)
June 30, 2024
Study Registration Dates
First Submitted
February 11, 2022
First Submitted That Met QC Criteria
February 11, 2022
First Posted (Actual)
February 23, 2022
Study Record Updates
Last Update Posted (Actual)
March 10, 2022
Last Update Submitted That Met QC Criteria
February 22, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pediatric deformity correction
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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