Results of Telescoping Nail In OI; a Case Series

NCT ID: NCT04694144

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2024-03-31

Brief Summary

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Assess the postoperative functional outcomes after surgical correction of skeletal deformities of lower limbs in osteogenesis imperfecta patients as regard ambulation status, postoperative complications and reoperation rate.

Detailed Description

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Osteogenesis imperfecta (OI) is a rare heterogeneous group of inherited disorders characterized by brittle bones, frequent fractures, and skeletal deformities that affect an individual's ability to walk. Based on Sillence classification, there are four types of OI; Type I (mild, non-deforming), Type II (perinatal lethal), Type III (severely deforming), and Type IV (moderately deforming). Recently 3 types added type V, VI and type VII.

Deformities of the long bones are common in patients with osteogenesis imperfecta particularly in the lower limbs Where they are also more severe. Multiple fractures can occur and the ability to walk may be compromised.

The goal of orthopaedic surgery implies the correction of long bone bowing, rotational malalignment, angular deformity and prevention or reduction of the fracture incidence .Surgical intervention in the form of multiple osteotomies, realignment and fixation by intramedullary rods can correct deformity of the long bones and provides internal support enhancing the potential for standing and assisted or independent walking Sofield and Millar, Page and Mead popularized the operation of multiple osteotomies and fixation by intramedullary rods. In 1963 the baily dubow nail was first introduced The telescopic rodding and nailing have been developed in order to obtain a long lasting osteosynthesis in a growing long bone, thus, reducing the need of replacement. The evolution of telescoping rods for the treatment of fractures and deformity in children with diminished bone Quality has resulted in an approved and commercially available new single entry telescopic rod system, the Fassier Duval Telescopic IM System (FD-rod).

In recent publications a high reoperation rate for proximal rod migration and a complication rate up to 40% because of rod migration, limited telescoping and joint protrusion was found.

We hope that our study will advance the proper surgical intervention for children with osteogenesis imperfecta for better functional outcomes

Conditions

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Osteogenesis Imperfecta

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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telescoping intramedullary nail

All osteogenesis imperfecta patients with lower limb skeletal deformities corrected with multiple corrective osteotomies and insertion of two parts male and female segments of intramedullary telescoping nail

Intervention Type DEVICE

Other Intervention Names

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growing nail

Eligibility Criteria

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Inclusion Criteria

* Age from 3-11 years
* Severe lower limb deformity presented with or without fracture

Exclusion Criteria

* Nondisplaced/incomplete fractures in minimally deformed bones
* Deformity angulation less than 20 degree
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nariman Abol Oyoun, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nariman Abol Oyoun, MD, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut University Hospital AUH

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed abdel zaher, MSc

Role: CONTACT

01021380107

Nariman Abol Oyoun, MD, Lecturer

Role: CONTACT

+201222302343

Facility Contacts

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Assiut University Hospital AUH

Role: primary

0020882333327

Assiut University Hospital AUH

Role: backup

Other Identifiers

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TIN in osteogenesis

Identifier Type: -

Identifier Source: org_study_id

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