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Comparison 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
District Headquarters Teaching Hospital Sahiwal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Transverse Fracture of Shaft of Tibia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 25, 2021
Last Updated
July 9, 2021
Sponsor
District Headquarters Teaching Hospital Sahiwal
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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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