Telescoping Nail in Osteogenesis Imperfecta

NCT06591546 | Active Not Recruiting DMC

• 1 other identifier: TNOMOIGC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Osteogenesis imperfecta

Outcome Measures

Primary Outcomes (1)

• Radiological score

  Bone union, callus formation, remodeling and fracture line

  During one year

Study Arms (1)

Telescoping nail

EXPERIMENTAL

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.

Device: Telescoping nail

Interventions

Telescoping nail DEVICE

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.

Telescoping nail

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Growing child (3-12 ys) Bony deformities with other symptoms and signs of OI

You may not qualify if:

• Old age (post Physeal closure). Other causes of bone deformities rather than OI

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Egypt

Asyut, Egypt

Location

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at Al-Azhar university Assuit

Model Details: Growing child (3-12 ys) Bony deformities with other symptoms and signs of OI

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2022
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (1)