NCT00610701

Brief Summary

The purpose of this study is to evaluate patients with tibial plateau fractures.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

March 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
7 months until next milestone

Results Posted

Study results publicly available

September 10, 2014

Completed
Last Updated

July 24, 2017

Status Verified

June 1, 2017

Enrollment Period

6.4 years

First QC Date

January 25, 2008

Results QC Date

April 10, 2014

Last Update Submit

June 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quadriceps Strength

    measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose

    (admission, 6 weeks, 3 months, 6 months) 1 year

Study Arms (2)

Anterior pin placement

EXPERIMENTAL

Anterior pin placement

Device: Anterior pin placement

Lateral pin placement

EXPERIMENTAL

Lateral pin placement

Device: Lateral pin placement

Interventions

Anteriorly-placed (front of the leg) femoral external fixator pins

Anterior pin placement

Laterally-placed (side of the leg) femoral external fixator pind

Lateral pin placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and above (adult population)
  • All open and closed tibial plateau fractures

You may not qualify if:

  • years of age and less (pediatric population)
  • Quadriplegic patients
  • Vascular Injury to Extremity
  • Ipsilateral femur fractures
  • Ipsilateral Hip fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Fractures, Closed

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Results Point of Contact

Title
Brett D. Crist, MD
Organization
University of Missouri

Study Officials

  • Brett Crist, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Co-Director of Trauma Services, Co-Director of Trauma Fellowship, Department of Orthopaedic Surgery

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 8, 2008

Study Start

March 1, 2006

Primary Completion

August 1, 2012

Study Completion

February 1, 2014

Last Updated

July 24, 2017

Results First Posted

September 10, 2014

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations