Progressive Splinting Status Post Elbow Fractures and Dislocations - Full Text View

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:

MedlinePlus related topics: Dislocations Fractures

U.S. FDA Resources

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Medical Center

More Information


Responsible Party:	William Obremskey, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00580866 History of Changes
Other Study ID Numbers:	051196
Study First Received:	December 19, 2007
Results First Received:	November 10, 2015
Last Updated:	July 22, 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 Dislocations Fractures, Comminuted Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2017

Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)