Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE December 27, 2007
Results First Submitted Date  ICMJE November 10, 2015
Results First Posted Date  ICMJE September 7, 2016
Last Update Posted Date September 7, 2016
Study Start Date  ICMJE September 2006
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
Elbow ROM at 12 Months [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively ]
The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 12 months post-operatively ]
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 )
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument. [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Progressive Splinting Status Post Elbow Fractures and Dislocations
Official Title  ICMJE Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations
Brief Summary The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.
Detailed Description

Fractures and dislocations about the elbow are high energy injuries which are often comminuted and associated with extensive soft tissue damage and are very difficult to treat. The most problematic complication for these fractures is the potential development of a cosmetic defect and functional disability due to the loss of 20 degrees to 30 degrees of terminal extension of the elbow. It has been found imperative that early motion and physical therapy be implemented to help produce the best results in terms of a patient's range of motion and decreases secondary surgeries.

We intend to examine a group of patients with distal humerus and elbow fracture/dislocations who use static stretching braces along with physical therapy (PT) within 3 weeks after surgery, in contrast to physical therapy treatment alone after surgery. The static stretching brace group will have a small electronic circuit attached to the brace that will record patient's usage.

Improvement of patient's overall functional outcome will also be measured by a standard functional outcome instrument, the Disabilities of Arm, Shoulder and Hand (DASH) form. The DASH Form is a standard functional outcome instrument specific to upper extremity injuries. In addition, a more general measure, the Visual Analog Scale (VAS), will be used to assess pain.

The use of the static motion brace may help eliminate the necessity of additional treatments, saving both pain and suffering, as well as monetary costs for the patient, while simultaneously producing a better long term functional and cosmetic outcome.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Upper Extremity Fracture
  • Upper Extremity Dislocation
  • Fractures, Comminuted
  • Elbow Fracture
  • Elbow Dislocation
Intervention  ICMJE Device: 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.
Other Names:
  • JAS Static Progressive Stretch
  • Joint Active Systems Brace (JAS Brace)
  • Static Stretching Brace
  • Static Progressive Stretching Brace
Study Arms  ICMJE
  • Experimental: Joint Active Systems Brace (JAS Brace)
    Elbow is placed in a brace to apply an extension force
    Intervention: Device: JAS Brace
  • No Intervention: PT Only Group
    No brace is used
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 22, 2016)
17
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2007)
50
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older
  • Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation
  • Agrees to participate and signs informed consent
  • English Speaking (outcome questionnaires are validated for English only)

Exclusion Criteria:

  • Less than 18 years of age
  • Closed Head Injury
  • Burn Injuries
  • Ipsilateral upper extremity fracture(s) requiring surgery
  • Nonunion of prior distal humerus fracture or fracture dislocation
  • Type 3 open distal humerus fracture dislocation
  • Insufficient fracture fixation to allow early range of motion
  • Transient population with no fixed address
  • Not willing to sign informed consent
  • Does not speak English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00580866
Other Study ID Numbers  ICMJE 051196
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Obremskey, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William T Obremskey, MD, MPH Vanderbilt University Medical Center
PRS Account Vanderbilt University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP