Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

This study has been terminated.
(Extremely low enrollment and very little follow-up for meaningful data)
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00610701
First received: January 25, 2008
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: April 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Fractures, Closed
Interventions: Device: Anterior pin placement
Device: Lateral pin placement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1 Anterior

Anterior

Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins

2 Lateral

Lateral

Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind


Participant Flow:   Overall Study
    1 Anterior     2 Lateral  
STARTED     15     20  
COMPLETED     5     9  
NOT COMPLETED     10     11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
initially based on power analysis for anticipated quad strength data, final numbers based on those completing study in each group

Reporting Groups
  Description
1-anterior Pin Placement

Anterior

Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins

2-lateral Pin Placement

Lateral

Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind

Total Total of all reporting groups

Baseline Measures
    1-anterior Pin Placement     2-lateral Pin Placement     Total  
Number of Participants  
[units: participants]
  5     9     14  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     9     14  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     5     7  
Male     3     4     7  
Region of Enrollment  
[units: participants]
     
United States     5     9     14  



  Outcome Measures

1.  Primary:   Quadriceps Strength   [ Time Frame: (admission, 6 weeks, 3 months, 6 months) 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Brett D. Crist, MD
Organization: University of Missouri
phone: 5738826562
e-mail: cristb@health.missouri.edu


No publications provided


Responsible Party: Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00610701     History of Changes
Other Study ID Numbers: IRB 1059937
Study First Received: January 25, 2008
Results First Received: April 10, 2014
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board