Results of Telescoping Nail In OI; a Case Series

NCT04694144 | Unknown

• 1 other identifier: TIN in osteogenesis
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteogenesis Imperfecta

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Bone consolidation

  All patients will be assessed clinically and radiologically one month after surgery.

• Timing of weight-bearing

  All patients will be assessed clinically within the first three months after surgery.

• Refracture

  All patients will be assessed clinically and radiologically for refracture within the first two years after surgery.

Other Outcomes (1)

• Knee Range of Motion

  All patients will be assessed clinically for knee range of motion 6 months after surgery.

Interventions

telescoping intramedullary nail DEVICE

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

Also known as: growing nail

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• Nondisplaced/incomplete fractures in minimally deformed bones
• Deformity angulation less than 20 degree

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital AUH

Asyut, 71526, Egypt

RECRUITING

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nariman Abol Oyoun, MD, Lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed abdel zaher, MSc

CONTACT

01021380107; mohamedabdelzaher999@yahoo.com

Nariman Abol Oyoun, MD, Lecturer

CONTACT

+201222302343; n.aboloyoun@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: January 5, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)