Elbow Dislocation, Elbow Fracture, Fractures, Comminuted, Upper Extremity Dislocation, Upper Extremity Fracture
Conditions
Keywords
Elbow, Upper Extremity Fractures, Distal Humerus, Elbow Injuries, Dislocations, Peri-articular Elbow Injuries
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.
Interventions
DEVICEJAS 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.
Sponsors
Vanderbilt University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elbow ROM at 12 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (DASH) Score | 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 ) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brace Group 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. | 10 |
| PT Only Group | 7 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Brace Group | PT Only Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 7 Participants | 17 Participants |
| Region of Enrollment United States | 10 participants | 7 participants | 17 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 |
Outcome results
Primary
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.
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively
Population: Elbow ROM at 12 months analysis. Data was not collected at 2 weeks, 6 weeks, 3 months, 6 months due to poor enrollment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brace Group | Elbow ROM at 12 Months | 121 degrees |
| PT Only Group | Elbow ROM at 12 Months | 123 degrees |
Secondary
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 )
Time frame: 12 months post-operatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brace Group | Disabilities of the Arm, Shoulder and Hand (DASH) Score | 25 scores on a scale |
| PT Only Group | Disabilities of the Arm, Shoulder and Hand (DASH) Score | 23 scores on a scale |