Results of Telescoping Nail In OI; a Case Series

Results of Telescoping Nail in. OI; A Case Series

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.

Study Overview

• Status: Recruiting
• Conditions: Osteogenesis Imperfecta
• Intervention / Treatment: Device: telescoping intramedullary nail

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 Type: Observational
• Enrollment (Anticipated): 22

Contacts and Locations

• Study Contact: Name: mohamed abdel zaher, MSc; Phone Number: 01021380107; Email: mohamedabdelzaher999@yahoo.com
• Study Contact Backup: Name: Nariman Abol Oyoun, MD, Lecturer; Phone Number: +201222302343; Email: n.aboloyoun@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71526
    • Recruiting
    • Assiut University Hospital AUH
    • Contact: Assiut University Hospital AUH; Phone Number: 0020882333327; Email: med@aun.edu.eg
    • Contact: Assiut University Hospital AUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all Osteogenesis imperfecta patients admitted at assiut university pediatric and main hospitals with age range 3- 11 years old presented with lower limb skeletal deformities with or without fracture will be included in our study

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulation status	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	All patients will be assessed clinically and radiologically for deformity 6 months after surgery.
Rod Complications	Radiographic evidence of rod problems including migration, bending, breakage, disengagement, jamming (failure of expansion/telescoping)	All patients will be assessed radiologically for evidence of rod complications within the first two years after surgery.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Range of Motion	The range within which the knee on the operated side can move in degrees	All patients will be assessed clinically for knee range of motion 6 months after surgery.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Nariman Abol Oyoun, MD, Lecturer, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: January 1, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Bone Diseases, Developmental; Osteochondrodysplasias; Collagen Diseases; Osteogenesis Imperfecta
• Other Study ID Numbers: TIN in osteogenesis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No