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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 2006p001424 |
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This trial is trying to understand if immobilization of the thumb after a non-displaced scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for free movement of the thumb, and in the United States it is a cast that immobilizes the thumb. This study is attempting to understand if there is a difference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cast that immobilizes the thumb | Experimental | Cast that immobilizes the thumb |
|
| Cast that does not immobilize the thumb | Active Comparator | Cast that does not immobilize the thumb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cast that immobilizes the thumb | Device | Cast that immobilizes the thumb |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Union | The investigators looked at the extent of fracture union after immobilization. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DASH Questionnaire | This questionnaire measures the disability of the upper extremity. The disability scale is ranked from 0 (least disability) to 100 (most disability). | 6 months |
| Modified Mayo Wrist Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C Ring, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusettes General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cast That Immobilizes the Thumb | Cast that immobilizes the thumb |
| FG001 | Cast That Does Not Immobilize the Thumb | Cast that does not immobilize the thumb |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cast That Immobilizes the Thumb | Cast that immobilizes the thumb |
| BG001 | Cast That Does Not Immobilize the Thumb | Cast that does not immobilize the thumb |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Extent of Union | The investigators looked at the extent of fracture union after immobilization. | Posted | Mean | Standard Deviation | percentage of union | 10 weeks |
|
|
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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 | Cast That Immobilizes the Thumb | Cast that immobilizes the thumb |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taylor Pong, Research Coordinator | Massachusetts General Hospital | 617-726-1569 | tpong1@partners.org |
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| Cast that does not immobilize the thumb | Device | Cast that does not immobilize the thumb |
|
The Modified Mayo Wrist Score evaluates wrist function after treatment. The total score ranges from 0 to 100, with higher scores indicating a better result.
| 6 months |
| Grip Strength | 6 months |
| Visual Analog Scale for Pain | The pain scale measures the amount of pain on a scale from 0 to 10, where 10 indicates the most pain and 0 is no pain. | 6 months |
| Range of Motion: Flexion | Range of motion measures the ability to move the wrist joint after injury. | 6 months |
| Range of Motion: Extension | Range of motion measures the ability to move the wrist joint after injury. | 6 months |
| Range of Motion: Ulnar Deviation | Range of motion measures the ability to move the wrist joint after injury. | 6 months |
| Range of Motion: Radial Deviation | Range of motion measures the ability to move the wrist joint after injury. | 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | DASH Questionnaire | This questionnaire measures the disability of the upper extremity. The disability scale is ranked from 0 (least disability) to 100 (most disability). | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Modified Mayo Wrist Score | The Modified Mayo Wrist Score evaluates wrist function after treatment. The total score ranges from 0 to 100, with higher scores indicating a better result. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Grip Strength | Posted | Mean | Standard Deviation | kilograms | 6 months |
|
|
|
| Secondary | Visual Analog Scale for Pain | The pain scale measures the amount of pain on a scale from 0 to 10, where 10 indicates the most pain and 0 is no pain. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Range of Motion: Flexion | Range of motion measures the ability to move the wrist joint after injury. | Posted | Mean | Standard Deviation | degrees | 6 months |
|
|
|
| Secondary | Range of Motion: Extension | Range of motion measures the ability to move the wrist joint after injury. | Posted | Mean | Standard Deviation | degrees | 6 months |
|
|
|
| Secondary | Range of Motion: Ulnar Deviation | Range of motion measures the ability to move the wrist joint after injury. | Posted | Mean | Standard Deviation | degrees | 6 months |
|
|
|
| Secondary | Range of Motion: Radial Deviation | Range of motion measures the ability to move the wrist joint after injury. | Posted | Mean | Standard Deviation | degrees | 6 months |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Cast That Does Not Immobilize the Thumb | Cast that does not immobilize the thumb | 0 | 31 | 0 | 31 |
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