Deformity of LimbNCT05251961
The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
A study testing operative deformity correction in people with Deformity of Limb, run by Sohag University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Deformity of Limb
- What is being tested?
- operative deformity correction
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 30 Jun 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cases of osteogenesis imperfecta
- metabolic bone deformities
- cases of hemimelia
- traumatic bone deformities
- complex or simple deformities
Who cannot join
- adult deformities
- short bone deformities
- very narrow medulla
- osteopetrosis
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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
- Conditions
- Deformity of Limb
- Being tested
- operative deformity correction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operative deformity correctionProcedure or surgery
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
- Evaluation of deformity angles correction after use of growing rods in comparison with preoperative angle
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deformity of LimbStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelmajeed Aboelabaas Abdelmajeed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251961
- Sponsor's protocol ID
- pediatric deformity correction
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30216208Persiani 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.
PubMed 30212425
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
- ClinicalTrials.gov ID
- NCT05251961
- Acronym / sponsor ID
- pediatric deformity correction
- Conditions
- Deformity of Limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Feb 2022 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- cases of osteogenesis imperfecta
- metabolic bone deformities
- cases of hemimelia
- traumatic bone deformities
- complex or simple deformities
Key exclusion criteria (4 listed)
- adult deformities
- short bone deformities
- very narrow medulla
- osteopetrosis
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 |
|---|---|---|
| operative deformity correction* 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 | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 30216208Sarikaya 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.
- Background: PubMed 30212425Persiani 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing operative deformity correction in people with Deformity of Limb, run by Sohag University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelmageed Aboelabbas (00201002711810, abdelmageed.ortho87@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Use Of Growing Rods In Pediatric Long Bones Deformity Correction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251961, which also lists 2 linked publications.
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 10 Mar 2022.