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: June 4, 2014
Last verified: June 2014

December 19, 2007
June 4, 2014
September 2006
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00580866 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Progressive Splinting Status Post Elbow Fractures and Dislocations
Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations

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.

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 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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Upper Extremity Fracture
  • Upper Extremity Dislocation
  • Fractures, Comminuted
  • Elbow Fracture
  • Elbow Dislocation
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
  • Static Stretching Brace
  • Static Progressive Stretching Brace
  • Active Comparator: Brace Group
    Intervention: Device: JAS Brace
  • No Intervention: PT Only Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580866
051196
No
William Obremskey, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: William T Obremskey, MD, MPH Vanderbilt University
Vanderbilt University
June 2014

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