Results of Telescoping Nail In OI; a Case Series

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Osteogenesis Imperfecta

Clinical Trial Details

NCT number	NCT04694144
Study type	Observational
Source	Assiut University
Contact	mohamed abdel zaher, MSc
Phone	01021380107
Email	mohamedabdelzaher999@yahoo.com
Status	Recruiting
Phase
Start date	December 1, 2020
Completion date	March 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03557567` - NGS Strategy Effectiveness in Molecular Diagnosis
Active, not recruiting	`NCT02531087` - Urinary Biomarkers of OI Pathobiology
Completed	`NCT01713231` - Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta	Phase 4
Completed	`NCT00655681` - Prevention of Post Operative Bone Loss in Children	N/A
Recruiting	`NCT06065111` - Study of Osteogenesis Imperfecta Tendon
Withdrawn	`NCT03216486` - An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta	Phase 2
Recruiting	`NCT06086613` - A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers	Phase 1
Completed	`NCT04009733` - Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI Study	N/A
Completed	`NCT04231916` - High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta	N/A
Active, not recruiting	`NCT02814591` - Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy
Completed	`NCT00982124` - An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta	Phase 3
Completed	`NCT00001305` - Growth Hormone Therapy in Osteogenesis Imperfecta	Phase 3
Completed	`NCT04119388` - Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta	N/A
Terminated	`NCT01679080` - The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta	Phase 2
Completed	`NCT00106028` - Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children	Phase 3
Recruiting	`NCT04152551` - Effects of Bisphosphonates on OI-Related Hearing Loss	Phase 4
Completed	`NCT00705120` - Treatment of Severe Osteogenesis Imperfecta by Allogeneic Bone Marrow Transplantation	Phase 1
Recruiting	`NCT04169568` - Osteogenesis Imperfecta Blood Pressure Study
Completed	`NCT03064074` - Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta	Phase 1
Not yet recruiting	`NCT05258019` - Site Preservation After Tooth Extraction

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.