Study of Tibial Shaft Fracture Fixation: Intramedullary Nailing Comparing With Dynamic Compression Plate
Study of Surgical Methods for Treatment of Tibial Fractures
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to determine which surgical approach is better for treatment of tibial shaft fracture
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedAugust 30, 2010
October 1, 2008
5 months
August 27, 2010
August 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time of fracture healing
identification of time of fracture healing in patients who underwent plate or nail methods
at 16 months post-operatively
Secondary Outcomes (3)
malunion
at 16 months post-operatively
nonunion
at 16 months post-operatively
infection
at 16 months post-operatively
Study Arms (2)
unreamed Intramedullary Nailing
OTHERtibial fracture fixed with unreamed Intramedullary Nailing
Dynamic Compression Plate
OTHERtibial fracture fixed with Dynamic Compression Plate
Interventions
we made a longitudinal incision 1 cm lateral to the tibial crest, expose the fracture, and retract the muscles laterally. After determining the length of plate, we used bending instruments to contour the plate to the anatomy then threaded plate holders used to position the plate on the bone. After that we placed the drill guide at the edge of the dynamic compression unit (DCU) portion of the plate hole without applying pressure and tightening of the cortex screws results in dynamic compression. We verified the screw position with a guide wire before insertion and then inserted the locking screw.
we inserted the nail, without reaming, across the fracture site, with particular attention being paid to the prevention of over distraction and the achievement of cortical contact of the fracture ends. An upper diameter limit of 10 mm and a nail measuring at least 2 mm less than the diameter measured at the isthmus of the tibia on anteroposterior and lateral radiographs were stipulated.
Eligibility Criteria
You may qualify if:
- patient with tibial shaft fracture
You may not qualify if:
- nothing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-zahra university hospital
Isfahan, Isfahan, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
hamidreza shemshaki, MD
MD,research comittee
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 27, 2010
First Posted
August 30, 2010
Study Start
October 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 30, 2010
Record last verified: 2008-10