- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05878548
Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient (OI)
January 29, 2024 updated by: Hesham Mohamed Elbaseet, Assiut University
O.I with NOF fixed by Wagner technique and telescoping nail
Study Overview
Status
Recruiting
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hesaham M Elbaseet, MD
- Phone Number: +2001007780689
- Email: drhesham20@aun.edu.eg
Study Locations
-
-
-
Assiut, Egypt, 71515
- Recruiting
- Faculty of Medicine Assiut University
-
Contact:
- Hesham M Elbaseet, MD
- Phone Number: +2001007780689
- Email: drhesham20@aun.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- OI
Exclusion Criteria:
- Not receiving Bisphosphonate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: fixation with Wagner technique and Telescoping nail
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
modified McKay's criteria
Time Frame: 1 year
|
hip function score the higher the score the better outcome graded into excellent, Good , Fair and Poor
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hesaham M Elbaseet, MD, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
May 18, 2023
First Submitted That Met QC Criteria
May 18, 2023
First Posted (Actual)
May 26, 2023
Study Record Updates
Last Update Posted (Estimated)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Fractures, Bone
- Wounds and Injuries
- Leg Injuries
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Bone Diseases
- Femoral Fractures
- Hip Injuries
- Hip Fractures
- Bone Diseases, Developmental
- Osteochondrodysplasias
- Collagen Diseases
- Femoral Neck Fractures
- Osteogenesis Imperfecta
Other Study ID Numbers
- NOFOI
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteogenesis Imperfecta
-
Nationwide Children's HospitalCompletedOsteogenesis Imperfecta Type III | Osteogenesis Imperfecta Type IIUnited States
-
Emory UniversityNot yet recruitingOsteogenesis Imperfecta | Osteogenesis Imperfecta Type III
-
Ultragenyx Pharmaceutical IncMereo BioPharmaCompletedOsteogenesis Imperfecta Type III | Osteogenesis Imperfecta Type IV | Osteogenesis Imperfecta, Type IUnited States, Canada, Denmark, France, United Kingdom
-
Angitia Biopharmaceuticals Guangzhou LimitedNot yet recruitingA Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR) (EIR)Osteogenesis Imperfecta (OI)China
-
Novartis PharmaceuticalsCompletedOsteogenesis ImperfectaUnited States
-
Shriners Hospitals for ChildrenNovartisCompleted
-
Istituto Ortopedico RizzoliRecruitingOsteogenesis Imperfecta | Osteogenesis Imperfecta (OI)Italy
-
University Hospital, GhentUniversity Ghent; Brittle Bone Society; Osteogenesis Imperfecta FederationRecruiting
-
Angitia Incorporated LimitedRecruitingOsteogenesis Imperfecta (OI)United States, France, Netherlands, Australia, Denmark, United Kingdom, Canada, Argentina
-
AmgenTerminatedOsteogenesis Imperfecta (OI)Canada, Czechia, Spain, United Kingdom, United States, Italy, Hungary, Australia, Belgium, France, Germany, Poland