Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia

July 9, 2021 updated by: Humayun Israr, District Headquarters Teaching Hospital Sahiwal
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sahiwal, Punjab, Pakistan, 57000
        • Orthopaedics Department ,DHQ Teaching Hospital Hospital Sahiwal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patients with closed transverse tibial fractures

Exclusion Criteria:

- Patients unsuitable for surgical intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group interlock
Intra medullary device used to treat tibial shaft fractures
Device: DCP
  1. Dynamic compression plating to compress the fracture
  2. Intramedullary device to share the load.
Other Names:
  • Interlock nailing
Active Comparator: group DCP (dynamic compression plate)
dynamic compression plate used to treat tibial shaft fractures
Device: DCP
  1. Dynamic compression plating to compress the fracture
  2. Intramedullary device to share the load.
Other Names:
  • Interlock nailing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight bearing
Time Frame: 12 weeks
when patient started to fully bear weight on affected leg after intervention
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of union
Time Frame: 12 weeks
time for union during which three cortices of the bone seem united radiologically
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

District Headquarters Teaching Hospital Sahiwal

Investigators

  • Principal Investigator: Humayun Israr, MBBS, District Headquarters Teaching Hospital Sahiwal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2019

Primary Completion (Actual)

January 20, 2020

Study Completion (Actual)

January 20, 2020

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHQTHS (Other Identifier: DHQTHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All data will probably be shared to fellow researchers after publication of study .

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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