Comparison of Tibial Plateau Fractures Outcomes Treated W... | NCT02035917

Studies
Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate

NCT02035917

Sponsor

Isfahan University of Medical Sciences

Status

Unknown status

Last Update Posted

Jan 14, 2014Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Tibial Fracture

Interventions

Locking plate
Non-Locking plate

Countries

Iran

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Apr 2014Estimated

Completion Date

Not provided

First Submitted Date

Jan 11, 2014

First Submission Date that Met QC Criteria

Jan 11, 2014

First Posted Date

Jan 14, 2014Estimated

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

Jan 11, 2014

Last Update Posted Date

Jan 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amin Nemati, Orthopedic surgery resident,Orthopedic department,Alzahra hospital,Isfahan University of Medical Sciences,Isfahan,Iran, Isfahan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Isfahan University of Medical SciencesOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Locking plate	Experimental		Device: Locking plate
Non-Locking plate	Active Comparator		Device: Non-Locking plate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Locking plate	Device		Locking plate
Non-Locking plate

Measure	Description	Time Frame
knee society knee score		ten months after surgery

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amin Nemati, Orthopedic surgery resident	Contact	00989131009918		nemati@med.mui.ac.ir

Overall Officials

Name	Affiliation	Role
Mohammad Ali Tahririan, Orthopedic surgeon	Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, Iran	Study Director
Mohsen Derakhshan, Orthopedic surgery resident	Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, Iran

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran	Recruiting	Isfahan	Isfahan	8174673461	Iran

Type	Date	Date Unknown
Release	Jun 12, 2016
Reset	Jul 21, 2016

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 12, 2016			Jul 21, 2016

Condition Browse Module

MeSH Terms

ID	Term
D013978	Tibial Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided