Primary Dynamization Versus Standard Interlocking Intramedullary Nail in Treatment of Tibial Shaft Fractures in Adults
1 other identifier
interventional
40
1 country
1
Brief Summary
fracture shfat tibia in adults treated by interlocking intramedullary nail by primary dynamic versus standard ways
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 19, 2023
CompletedFirst Posted
Study publicly available on registry
November 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 27, 2023
November 1, 2023
1 year
November 19, 2023
November 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Dynamization Interlocking Intramedullary Tibial Nail
use only distal screws away from fracture site
12 months
Study Arms (2)
primary dynamization interlocking intramedullary tibial nail
ACTIVE COMPARATORstandard interlocking intramedullary tibial nail
ACTIVE COMPARATORInterventions
primary dynamization versus standard interlocking intramedullary tibial nail
Eligibility Criteria
You may qualify if:
- adult patients (18-50) fractures with mid shaft or distal shaft tibial fracture AO type A1, A2 and A3 and minimal soft tisuue damage
You may not qualify if:
- patients with comminuted fractures , old age more than 50 years , sclerotic bone , osteoporosis, osteopetrosis and bone deformity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag University hospitals
Sohag, Egypt
Related Publications (5)
Whelan DB, Bhandari M, Stephen D, Kreder H, McKee MD, Zdero R, Schemitsch EH. Development of the radiographic union score for tibial fractures for the assessment of tibial fracture healing after intramedullary fixation. J Trauma. 2010 Mar;68(3):629-32. doi: 10.1097/TA.0b013e3181a7c16d.
PMID: 19996801BACKGROUNDFracture and dislocation compendium. Orthopaedic Trauma Association Committee for Coding and Classification. J Orthop Trauma. 1996;10 Suppl 1:v-ix, 1-154. No abstract available.
PMID: 8814583BACKGROUNDOmerovic D, Lazovic F, Hadzimehmedagic A. Static or dynamic intramedullary nailing of femur and tibia. Med Arch. 2015 Apr;69(2):110-3. doi: 10.5455/medarh.2015.69.110-113. Epub 2015 Apr 6.
PMID: 26005261BACKGROUNDVaughn J, Gotha H, Cohen E, Fantry AJ, Feller RJ, Van Meter J, Hayda R, Born CT. Nail Dynamization for Delayed Union and Nonunion in Femur and Tibia Fractures. Orthopedics. 2016 Nov 1;39(6):e1117-e1123. doi: 10.3928/01477447-20160819-01. Epub 2016 Aug 30.
PMID: 27575039BACKGROUNDElsayed M, Khalefa AH, Mazen MSH, Ahmed KFE. Primary dynamization versus standard static interlocking nailing in treatment of tibial shaft fractures in adults: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Dec 12. doi: 10.1186/s12891-025-09376-3. Online ahead of print.
PMID: 41387845DERIVED
Central Study Contacts
Abd el-rahman Hz Khalefa
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident of Orthopaedic department, Sohag University Hospitals
Study Record Dates
First Submitted
November 19, 2023
First Posted
November 27, 2023
Study Start
September 1, 2023
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
November 27, 2023
Record last verified: 2023-11