Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)

Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations

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.

Study Overview

• Status: Terminated
• Conditions: Elbow Fracture; Upper Extremity Fracture; Fractures, Comminuted; Elbow Dislocation; Upper Extremity Dislocation
• Intervention / Treatment: Device: JAS Brace

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-8774
      • Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elbow ROM at 12 Months	The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.	2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabilities of the Arm, Shoulder and Hand (DASH) Score	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 )	12 months post-operatively

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: William T Obremskey, MD, MPH, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (Estimate): December 27, 2007

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: July 22, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Elbow; Upper Extremity Fractures; Distal Humerus; Elbow Injuries; Dislocations; Peri-articular Elbow Injuries
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Fractures, Bone; Joint Dislocations; Fractures, Comminuted
• Other Study ID Numbers: 051196