NCT05251961

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

February 11, 2022

Last Update Submit

February 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Interventions

* 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

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • cases of osteogenesis imperfecta
  • metabolic bone deformities
  • cases of hemimelia
  • traumatic bone deformities
  • complex or simple deformities

You may not qualify if:

  • adult deformities
  • short bone deformities
  • very narrow medulla
  • osteopetrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 30216208BACKGROUND
  • 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.

    PMID: 30212425BACKGROUND

Central Study Contacts

Abdelmageed Aboelabbas

CONTACT

Ahmad Addosooki

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 11, 2022

First Posted

February 23, 2022

Study Start

April 1, 2022

Primary Completion

April 30, 2024

Study Completion

June 30, 2024

Last Updated

March 10, 2022

Record last verified: 2022-02