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UnknownNCT04694144

Results of Telescoping Nail In OI; a Case Series

Results of Telescoping Nail in. OI; A Case Series

Status
Unknown
Phase
Study type
Observational
Enrollment
22 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
3 Years – 11 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
DEVICEtelescoping intramedullary nailAll 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

Timeline

Start date
2020-12-01
Primary completion
2023-12-01
Completion
2024-03-01
First posted
2021-01-05
Last updated
2021-09-02

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04694144. Inclusion in this directory is not an endorsement.