NCT02035917

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

First QC Date

January 11, 2014

Last Update Submit

January 11, 2014

Conditions

Tibial Fracture

Outcome Measures

Primary Outcomes (1)

  • knee society knee score

    ten months after surgery

Study Arms (2)

Locking plate

EXPERIMENTAL
Device: Locking plate

Non-Locking plate

ACTIVE COMPARATOR
Device: Non-Locking plate

Interventions

Locking plateDEVICE
Locking plate
Non-Locking plateDEVICE
Non-Locking plate

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • unilateral closed tibia plateau fracture

You may not qualify if:

  • patients who have been treated with casting or screw
  • history of diabetes mellitus
  • evidences of pathological fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran

Isfahan, Isfahan, 8174673461, Iran

RECRUITING

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amin Nemati, Orthopedic surgery resident

CONTACT

00989131009918nemati@med.mui.ac.ir

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic surgery resident,Orthopedic department,Alzahra hospital,Isfahan University of Medical Sciences,Isfahan,Iran

Study Record Dates

First Submitted

January 11, 2014

First Posted

January 14, 2014

Primary Completion

April 1, 2014

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

IR(1)