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Primary Question: "When splinting is used to improve motion in post-traumatic stiff elbows, is there a significant difference in gains in motion achieved between static progressive or dynamic splint approaches?"
Secondary Question: "Is there a significant difference in patient compliance with static progressive versus dynamic splint use, and does this effect final ulnohumeral motion outcomes?"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Static-progressive splint | Experimental |
| |
| Dynamic Splint | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Static-Progressive Splint | Device | Static progressive splinting is a well-established adjunct for restoring elbow motion. Such splints apply a static stress relaxation force to the elbow tissues, which is sequentially increased, as motion is achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Arc of Flexion and Extension | Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment. | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Only English speaking patients will be eligible for the study since questionnaires have not been validated in other languages.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Static-progressive Splint | Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch. |
| FG001 | Dynamic Splint | Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Static-progressive Splint | Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch. |
| BG001 | Dynamic Splint |
| 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 | Change in Arc of Flexion and Extension | Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment. | Posted | Mean | Full Range | Degrees | baseline and 6 months |
|
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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 | Static-progressive Splint | Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch. |
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Evaluation of <80% of enrolled patients at planned follow-up times; musculoskeletal injury patients are difficult to maintain in protocol. Some violations where enrollment/evaluation points were slightly outside the planned range of acceptable times.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Ring | Massachusetts General Hospital | 617-724-3953 | dring@partners.org |
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| ID | Term |
|---|---|
| D013165 | Splints |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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| Dynamic Splint | Device | Dynamic splints are a popular alternative, and apply a constant prolonged force to the tissues as additional motion is achieved. |
|
Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| 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) Questionnaire | The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function. | Posted | Mean | Full Range | units on a scale | 12 months |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Dynamic Splint | Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch. | 0 | 31 | 0 | 31 |
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| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |