Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Upper Extremity Fracture; Upper Extremity Dislocation; Fractures, Comminuted; Elbow Fracture; Elbow Dislocation	Device: JAS Brace	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
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
Study Start Date :	September 2006
Actual Primary Completion Date :	July 2009
Actual Study Completion Date :	July 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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 )

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	William Obremskey, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00580866 History of Changes
Other Study ID Numbers:	051196
First Posted:	December 27, 2007
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