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Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)

This study has been terminated.
(low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580866
First Posted: December 27, 2007
Last Update Posted: September 7, 2016
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.
Information provided by (Responsible Party):
William Obremskey, Vanderbilt University
  Purpose
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.

Condition Intervention
Upper Extremity Fracture Upper Extremity Dislocation Fractures, Comminuted Elbow Fracture Elbow Dislocation Device: JAS Brace

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations

Resource links provided by NLM:


Further study details as provided by William Obremskey, Vanderbilt University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 )


Enrollment: 17
Study Start Date: September 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Joint Active Systems Brace (JAS Brace)
Elbow is placed in a brace to apply an extension force
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
No Intervention: PT Only Group
No brace is used

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580866


Locations
United States, Tennessee
Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-8774
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: William T Obremskey, MD, MPH Vanderbilt University Medical Center
  More Information

Responsible Party: William Obremskey, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00580866     History of Changes
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
Last Verified: July 2016

Keywords provided by William Obremskey, Vanderbilt University:
Elbow
Upper Extremity Fractures
Distal Humerus
Elbow Injuries
Dislocations
Peri-articular Elbow Injuries

Additional relevant MeSH terms:
Fractures, Bone
Joint Dislocations
Fractures, Comminuted
Wounds and Injuries
Bone Diseases
Musculoskeletal Diseases