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Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
William Obremskey, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00580866
First received: December 19, 2007
Last updated: July 22, 2016
Last verified: July 2016
Results First Received: November 10, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Upper Extremity Fracture
Upper Extremity Dislocation
Fractures, Comminuted
Elbow Fracture
Elbow Dislocation
Intervention: Device: JAS Brace

  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
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Reporting Groups
  Description
Brace Group JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
PT Only Group No text entered.

Participant Flow:   Overall Study
    Brace Group     PT Only Group  
STARTED     10     7  
COMPLETED     8     5  
NOT COMPLETED     2     2  
Lost to Follow-up                 2                 2  



  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.
No text entered.

Reporting Groups
  Description
Brace Group JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
PT Only Group No text entered.
Total Total of all reporting groups

Baseline Measures
    Brace Group     PT Only Group     Total  
Number of Participants  
[units: participants]
  10     7     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     7     17  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     2     4  
Male     8     5     13  
Region of Enrollment  
[units: participants]
     
United States     10     7     17  



  Outcome Measures
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1.  Primary:   Elbow ROM at 12 Months   [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively ]

2.  Secondary:   Disabilities of the Arm, Shoulder and Hand (DASH) Score   [ Time Frame: 12 months post-operatively ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William Obremskey
Organization: Vanderbilt
phone: 6159363630
e-mail: william.obremskey@Vanderbilt.Edu



Responsible Party: William Obremskey, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00580866     History of Changes
Other Study ID Numbers: 051196
Study First Received: December 19, 2007
Results First Received: November 10, 2015
Last Updated: July 22, 2016
Health Authority: United States: Institutional Review Board