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low accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Joint Active Systems Brace (JAS Brace) | Experimental | Elbow is placed in a brace to apply an extension force |
|
| PT Only Group | No Intervention | No brace is used |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAS Brace | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William T Obremskey, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8774 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | PT Only Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | PT Only Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Elbow ROM at 12 months analysis. Data was not collected at 2 weeks, 6 weeks, 3 months, 6 months due to poor enrollment. | Posted | Mean | 95% Confidence Interval | degrees | 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Obremskey | Vanderbilt | 6159363630 | william.obremskey@Vanderbilt.Edu |
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| ID | Term |
|---|---|
| D018460 | Fractures, Comminuted |
| D000092482 | Elbow Fractures |
| D000092464 | Elbow Injuries |
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D001134 | Arm Injuries |
| D007592 | Joint Diseases |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
| 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 ) | Posted | Mean | 95% Confidence Interval | scores on a scale | 12 months post-operatively |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | PT Only Group | 0 | 7 | 0 | 7 |
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| D009140 |
| Musculoskeletal Diseases |