Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)

• ClinicalTrials.gov Identifier: NCT00580866
• Recruitment Status: Terminated
• First Posted: December 27, 2007
• Results First Posted: September 7, 2016
• Last Update Posted: September 7, 2016
• Sponsor: Vanderbilt University
• Information provided by (Responsible Party): William Obremskey, Vanderbilt University

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• 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:

Joint Dislocations; Fractures, Bone; Fractures, Comminuted; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases