Back to resultsComparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia
Primary Purpose
Transverse Fracture of Shaft of Tibia
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
DCP
Sponsored by
About this trial
This is an interventional health services research trial for Transverse Fracture of Shaft of Tibia
Eligibility Criteria
Inclusion Criteria:
- Patients with closed transverse tibial fractures
Exclusion Criteria:
- Patients unsuitable for surgical intervention
Sites / Locations
- Orthopaedics Department ,DHQ Teaching Hospital Hospital Sahiwal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group interlock
group DCP (dynamic compression plate)
Arm Description
Intra medullary device used to treat tibial shaft fractures
dynamic compression plate used to treat tibial shaft fractures
Outcomes
Primary Outcome Measures
weight bearing
when patient started to fully bear weight on affected leg after intervention
Secondary Outcome Measures
time of union
time for union during which three cortices of the bone seem united radiologically
Full Information
NCT ID
NCT04958564
First Posted
June 25, 2021
Last Updated
July 9, 2021
Sponsor
District Headquarters Teaching Hospital Sahiwal
1. Study Identification
Unique Protocol Identification Number
NCT04958564
Brief Title
Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia
Official Title
Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
District Headquarters Teaching Hospital Sahiwal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Study aims to compare two treatment modalities for treatment of transverse fractures of tibia. One is Intramedullary interlocking nail and the other is dynamic compression plate.
Detailed Description
This study is a comparison of two devices used to teat transverse fractures of tibia and these include intra medullary rod popularly known as intra medullary nail and the second is a weight bearing device know as dynamic compression plate which is fixed with screws to diaphyseal segment of bone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transverse Fracture of Shaft of Tibia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group interlock
Arm Type
Active Comparator
Arm Description
Intra medullary device used to treat tibial shaft fractures
Arm Title
group DCP (dynamic compression plate)
Arm Type
Active Comparator
Arm Description
dynamic compression plate used to treat tibial shaft fractures
Intervention Type
Device
Intervention Name(s)
DCP
Other Intervention Name(s)
Interlock nailing
Intervention Description
Dynamic compression plating to compress the fracture
Intramedullary device to share the load.
Primary Outcome Measure Information:
Title
weight bearing
Description
when patient started to fully bear weight on affected leg after intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
time of union
Description
time for union during which three cortices of the bone seem united radiologically
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Patients with closed transverse tibial fractures
Exclusion Criteria:
- Patients unsuitable for surgical intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Humayun Israr, MBBS
Organizational Affiliation
District Headquarters Teaching Hospital Sahiwal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedics Department ,DHQ Teaching Hospital Hospital Sahiwal
City
Sahiwal
State/Province
Punjab
ZIP/Postal Code
57000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
All data will probably be shared to fellow researchers after publication of study .
Learn more about this trial
Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia
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