Results of Telescoping Nail In OI; a Case Series

Osteogenesis Imperfecta Clinical Trial

Official title:

Results of Telescoping Nail in. OI; A Case Series

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694144
• Other study ID #: TIN in osteogenesis
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: March 2024

Study information

• Verified date: August 2021
• Source: Assiut University
• Contact: mohamed abdel zaher, MSc
• Phone: 01021380107
• Email: mohamedabdelzaher999[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Device:
• 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

Locations

Country	Name	City	State
Egypt	Assiut University Hospital AUH	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.