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Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00580866
First received: December 19, 2007
Last updated: June 5, 2009
Last verified: June 2009
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: September 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brace Group 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
No Intervention: PT Only Group

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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: William T. Obremskey, MD, MPH, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00580866     History of Changes
Other Study ID Numbers: 051196
Study First Received: December 19, 2007
Last Updated: June 5, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013