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Telescoping Nail in Osteogenesis Imperfecta

NCT06591546 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-09-19

No results posted yet for this study

Summary

Osteogenesis Imperfecta (OI) is an autosomal dominant disorder that mainly affects the bones. Bones break easily. The severity may be mild to severe.

OI includes a blue tinge to the sclera of the eye, short height, loose joints, hearing loss, breathing problems and problems with the teeth. Complications may include cervical and aortic artery dissection.

Telescoping Nail Osteosynthesis:

The necessity for such treatment is given by the rapidly evolving anterior bowing (sometimes associated with rotation) and the increasing incidence of bone fracturing after cast removal. The decision to choose Sheffield-Millard osteotomies is based on the more than 20° angulation and the narrow medullar channel that makes reaming the only solution for passing the rod. Sometimes, in very severe cases, when the distance between the epiphysis gets smaller as the bone gets more and more bowed, it is imperative to do a shorting of the segment so that the soft tissues are not put in excessive tension after alignment.

Until the development of this technique, doctors used Kirschnerwire ,Kuntscher nails , Rush nails , Ender nails and most recently, elastic nailing . All the techniques had good short-term results, with good bone alignment and prevention of the refracturing of the bone. However, the biggest problem with these materials was that the patients outgrew them very fast, and problems like secondary bowing and refracturing appeared.

The aim of this study is the evaluation of the management of skeletal deformities in growing children with OI with telescoping nails.

This cross-sectional study was conducted. Twenty patients were included in this study operated at Alazhar University Hospital Assuit. The duration of the study ranged from 24-36 months.

Conditions

  • Osteogenesis

Interventions

DEVICE

Telescoping nail

The implant used in this study is Fassier Duval type of telescoping nail. The Fassier-Duval rod has certain advantages: the design is dedicated to minimally invasive, ideally percutaneous, approaches sparing joint cartilage at implant positioning and removal. This reduces the risk of delayed growth and infection, with lower scar impact; instrumentation is much better than the very basic Dubow-Bailey instrumentation; maximum diameter is greater: 6.4 mm, compared to 5 mm for Bailey-Dubow; The length of the female part can be adapted, including intraoperatively. Precutting according to the surgeon's measurement can be adjusted intraoperatively with a dedicated circular saw with a diamond disc.

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-10-30
Completion
2024-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06591546 on ClinicalTrials.gov