Comparison of Interlock Nailing Versus Dynamic Compressio... | NCT04958564

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

NCT04958564

Sponsor

District Headquarters Teaching Hospital Sahiwal

Status

Completed

Last Update Posted

Jul 12, 2021Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Transverse Fracture of Shaft of Tibia

Interventions

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2019Actual

Primary Completion Date

Jan 20, 2020Actual

Completion Date

Jan 20, 2020Actual

First Submitted Date

Jun 25, 2021

First Submission Date that Met QC Criteria

Jul 9, 2021

First Posted Date

Jul 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2021

Last Update Posted Date

Jul 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Humayun Israr, clinical professsor and dean of orthopaedics department, District Headquarters Teaching Hospital SahiwalPrincipal Investigator

Lead Sponsor

District Headquarters Teaching Hospital SahiwalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group interlock	Active Comparator	Intra medullary device used to treat tibial shaft fractures	Device: DCP
group DCP (dynamic compression plate)	Active Comparator	dynamic compression plate used to treat tibial shaft fractures	Device: DCP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DCP	Device	Dynamic compression plating to compress the fracture Intramedullary device to share the load.	group DCP (dynamic compression plate) group interlock

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients with closed transverse tibial fractures

Exclusion Criteria:

- Patients unsuitable for surgical intervention

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Humayun Israr, MBBS	District Headquarters Teaching Hospital Sahiwal	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedics Department ,DHQ Teaching Hospital Hospital Sahiwal		Sahiwal	Punjab Province	57000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided