Progressive Splinting Status Post Elbow Fractures and Dislocations

Elbow Fracture Clinical Trial

— JAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00580866
• Other study ID #: 051196
• Status: Terminated
• Phase: N/A
• First received: December 19, 2007
• Last updated: June 4, 2014
• Start date: September 2006
• Est. completion date: July 2009

Study information

• Verified date: June 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dislocations
• Elbow Dislocation
• Elbow Fracture
• Fractures, Bone
• Fractures, Comminuted
• Upper Extremity Dislocation
• Upper Extremity Fracture

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument.		2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively	No