Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05878548
Other study ID # NOFOI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date April 1, 2024

Study information

Verified date January 2024
Source Assiut University
Contact Hesaham M Elbaseet, MD
Phone +2001007780689
Email drhesham20@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

O.I with NOF fixed by Wagner technique and telescoping nail


Description:

osteogenesis imperfecta (Sillence Type IV) sustained neck of femur fracture after fall on ground. He had proximal femoral anterolateral bowing on top of inserted rod 4 years ago. He was treated with corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture. One year after operation the patient gained satisfactory functional outcome with union of NOF fracture and correction of femoral deformity. This rare case illustrates the anticipated difficulties in managing neck of femur fracture in osteogenesis imperfect patients. The method of fixation with Wagner technique can achieve stable fixation for solid healing in fragility fractures like this and the least interference with telescoping nail insertion.


Recruitment information / eligibility

Status Recruiting
Enrollment 1
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 2 Years to 14 Years
Eligibility Inclusion Criteria: - OI Exclusion Criteria: - Not receiving Bisphosphonate

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture
corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture

Locations

Country Name City State
Egypt faculty of medicine Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Fralinger DJ, Kraft DB, Rogers KJ, Thacker MM, Kruse RW, Franzone JM. The Fate of the Bent Rod in Children With Osteogenesis Imperfecta. J Pediatr Orthop. 2023 Jul 1;43(6):e465-e470. doi: 10.1097/BPO.0000000000002409. Epub 2023 Apr 6. — View Citation

Hidalgo Perea S, Green DW. Osteogenesis imperfecta: treatment and surgical management. Curr Opin Pediatr. 2021 Feb 1;33(1):74-78. doi: 10.1097/MOP.0000000000000968. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary modified McKay's criteria hip function score the higher the score the better outcome graded into excellent, Good , Fair and Poor 1 year
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