Clinical trial NCT00580866: Progressive Splinting Status Post Elbow Fractures and Dislocations
Official title: Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Upper Extremity Fracture
Upper Extremity Dislocation
Fractures, Comminuted
Elbow Fracture
Elbow Dislocation
Keywords: Elbow
Upper Extremity Fractures
Distal Humerus
Elbow Injuries
Dislocations
Peri-articular Elbow Injuries
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Elbow ROM at 12 Months
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 12 months post-operatively
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William T Obremskey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: