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RecruitingNCT05878548OIUpdated Jan 31, 2024

Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient

An interventional study of corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture in Osteogenesis Imperfecta, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
2 Years to 14 Years
Sex
All
01

Study summary

O.I with NOF fixed by Wagner technique and telescoping nail

Read the detailed description

osteogenesis imperfecta (Sillence Type IV) sustained neck of femur fracture after fall on ground. He had proximal femoral anterolateral bowing on top of inserted rod 4 years ago. He was treated with corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture. One year after operation the patient gained satisfactory functional outcome with union of NOF fracture and correction of femoral deformity. This rare case illustrates the anticipated difficulties in managing neck of femur fracture in osteogenesis imperfect patients. The method of fixation with Wagner technique can achieve stable fixation for solid healing in fragility fractures like this and the least interference with telescoping nail insertion.

02

Conditions studied

  • Osteogenesis Imperfecta

Keywords

  • Osteogenesis imperfecta
  • fracture neck of femur
  • telescoping nail
03

In context

Osteogenesis Imperfecta

84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.

This study's planned enrollment of 1 is below the median of 28 across 60 interventional studies indexed under Osteogenesis Imperfecta.

Browse Osteogenesis Imperfecta studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • OI

Exclusion criteria

Exclusion Criteria:

  • Not receiving Bisphosphonate
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (estimated)

Study arms

  • Experimental
    fixation with Wagner technique and Telescoping nail

    corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture

    Procedure: corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture

Interventions

  • Procedurecorrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture

    corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture

06

What researchers measure

Primary outcomes

  1. modified McKay's criteria

    hip function score the higher the score the better outcome graded into excellent, Good , Fair and Poor

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Hidalgo Perea S, Green DW. Osteogenesis imperfecta: treatment and surgical management. Curr Opin Pediatr. 2021 Feb 1;33(1):74-78. doi: 10.1097/MOP.0000000000000968. PubMed 33278111 ↗
  • Fralinger DJ, Kraft DB, Rogers KJ, Thacker MM, Kruse RW, Franzone JM. The Fate of the Bent Rod in Children With Osteogenesis Imperfecta. J Pediatr Orthop. 2023 Jul 1;43(6):e465-e470. doi: 10.1097/BPO.0000000000002409. Epub 2023 Apr 6. PubMed 37026790 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05878548
Lead sponsor
Assiut University
Responsible party
Hesham Mohamed Elbaseet (Dr., Assiut University) — Principal investigator
First posted
May 26, 2023
Start date
Aug 1, 2023
Primary completion
Apr 1, 2024 (estimated)
Completion
Apr 1, 2024 (estimated)
Last update
Jan 31, 2024

Study contacts

Hesaham M Elbaseet, MD
Contact
drhesham20@aun.edu.eg
+2001007780689
Hesaham M Elbaseet, MD
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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