Results of Telescoping Nail In OI; a Case Series

• Conditions: Osteogenesis Imperfecta

• Registration Number: NCT04694144
• Lead Sponsor: Assiut University

Brief 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

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2021-01-01
• Study First Posted: 2021-01-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-28
• Last Update Posted: 2021-09-02
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rod Complications	All patients will be assessed radiologically for evidence of rod complications within the first two years after surgery.	Radiographic evidence of rod problems including migration, bending, breakage, disengagement, jamming (failure of expansion/telescoping)
Ambulation status	All patients will be assessed clinically and radiologically for deformity 6 months after surgery.	the mobility status of each child will be allocated to one of the scores of the Gillette Functional Assessment Questionnaire Ambulation Scale and Hoffer and Bollock score

Secondary Outcome Measures

Name	Time	Method
Bone consolidation	All patients will be assessed clinically and radiologically one month after surgery.	patients will be assessed for the average time in weeks of consolidation at the osteotomy site(s)
Timing of weight-bearing	All patients will be assessed clinically within the first three months after surgery.	The average time in weeks until full weight bearing
Refracture	All patients will be assessed clinically and radiologically for refracture within the first two years after surgery.	The occurrence of a second fracture at the same long bone with the rod in place or in association with any rod complication

Trial Locations

Locations (1)

Assiut University Hospital AUH; 🇪🇬 Assiut, Egypt