Back to resultsComparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate
Primary Purpose
Tibial Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Locking plate
Non-Locking plate
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fracture
Eligibility Criteria
Inclusion Criteria:
- unilateral closed tibia plateau fracture
Exclusion Criteria:
- patients who have been treated with casting or screw
- history of diabetes mellitus
- evidences of pathological fractures
Sites / Locations
- Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, IranRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Locking plate
Non-Locking plate
Arm Description
Outcomes
Primary Outcome Measures
knee society knee score
Secondary Outcome Measures
Full Information
NCT ID
NCT02035917
First Posted
January 11, 2014
Last Updated
January 11, 2014
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02035917
Brief Title
Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
this study will perform to compare the results and functional outcomes of tibial plateau fractures treated with non-locking and locking plate fixation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Locking plate
Arm Type
Experimental
Arm Title
Non-Locking plate
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Locking plate
Intervention Type
Device
Intervention Name(s)
Non-Locking plate
Primary Outcome Measure Information:
Title
knee society knee score
Time Frame
ten months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unilateral closed tibia plateau fracture
Exclusion Criteria:
patients who have been treated with casting or screw
history of diabetes mellitus
evidences of pathological fractures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amin Nemati, Orthopedic surgery resident
Phone
00989131009918
Email
nemati@med.mui.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Ali Tahririan, Orthopedic surgeon
Organizational Affiliation
Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, Iran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohsen Derakhshan, Orthopedic surgery resident
Organizational Affiliation
Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
ZIP/Postal Code
8174673461
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amin Nemati, Orthopedic surgery resident
12. IPD Sharing Statement
Learn more about this trial
Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate
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