Progressive Splinting Status Post Elbow Fractures and Dislocations

NCT ID: NCT00580866

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-07-31

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.

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.

Conditions

Upper Extremity Fracture; Upper Extremity Dislocation; Fractures, Comminuted; Elbow Fracture; Elbow Dislocation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Joint Active Systems Brace (JAS Brace)

Elbow is placed in a brace to apply an extension force

Group Type: EXPERIMENTAL

JAS Brace

Intervention Type: DEVICE

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.

PT Only Group

No brace is used

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

JAS Static Progressive Stretch; Joint Active Systems Brace (JAS Brace); Static Stretching Brace; Static Progressive Stretching Brace

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

William Obremskey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William T Obremskey, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

051196

Identifier Type: -

Identifier Source: org_study_id