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Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00580866
Recruitment Status : Terminated (low accrual)
First Posted : December 27, 2007
Results First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
William Obremskey, Vanderbilt University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Upper Extremity Fracture
Upper Extremity Dislocation
Fractures, Comminuted
Elbow Fracture
Elbow Dislocation
Intervention Device: JAS Brace
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brace Group PT Only Group
Hide Arm/Group Description 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. [Not Specified]
Period Title: Overall Study
Started 10 7
Completed 8 5
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Arm/Group Title Brace Group PT Only Group Total
Hide Arm/Group Description 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. [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 10 7 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
7
 100.0%
17
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 17 participants
Female
2
  20.0%
2
  28.6%
4
  23.5%
Male
8
  80.0%
5
  71.4%
13
  76.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 7 participants 17 participants
10 7 17
1.Primary Outcome
Title Elbow ROM at 12 Months
Hide Description The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.
Time Frame 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Elbow ROM at 12 months analysis. Data was not collected at 2 weeks, 6 weeks, 3 months, 6 months due to poor enrollment.
Arm/Group Title Brace Group PT Only Group
Hide Arm/Group Description:
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.
[Not Specified]
Overall Number of Participants Analyzed 8 5
Mean (95% Confidence Interval)
Unit of Measure: degrees
121
(110 to 130)
123
(119 to 129)
2.Secondary Outcome
Title Disabilities of the Arm, Shoulder and Hand (DASH) Score
Hide Description Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )
Time Frame 12 months post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brace Group PT Only Group
Hide Arm/Group Description:
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.
[Not Specified]
Overall Number of Participants Analyzed 8 5
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
25
(21 to 29)
23
(19 to 27)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brace Group PT Only Group
Hide Arm/Group Description 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. [Not Specified]
All-Cause Mortality
Brace Group PT Only Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Brace Group PT Only Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brace Group PT Only Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/7 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: William Obremskey
Organization: Vanderbilt
Phone: 6159363630
EMail: william.obremskey@Vanderbilt.Edu
Layout table for additonal information
Responsible Party: William Obremskey, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00580866    
Other Study ID Numbers: 051196
First Submitted: December 19, 2007
First Posted: December 27, 2007
Results First Submitted: November 10, 2015
Results First Posted: September 7, 2016
Last Update Posted: September 7, 2016