Non-displaced Scaphoid Fractures
Conditions
Brief summary
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.
Interventions
DEVICECast that immobilizes the thumb
Cast that immobilizes the thumb
DEVICECast that does not immobilize the thumb
Cast that does not immobilize the thumb
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. Isolated fracture of the scaphoid 3. No displacement of the scaphoid fracture on CT scan
Exclusion criteria
1. Associated ipsilateral ligament injury or fracture 2. Pregnant Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Union | 10 weeks | The investigators looked at the extent of fracture union after immobilization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Mayo Wrist Score | 6 months | 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. |
| Grip Strength | 6 months | — |
| Visual Analog Scale for Pain | 6 months | 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. |
| DASH Questionnaire | 6 months | This questionnaire measures the disability of the upper extremity. The disability scale is ranked from 0 (least disability) to 100 (most disability). |
| Range of Motion: Extension | 6 months | Range of motion measures the ability to move the wrist joint after injury. |
| Range of Motion: Ulnar Deviation | 6 months | Range of motion measures the ability to move the wrist joint after injury. |
| Range of Motion: Radial Deviation | 6 months | Range of motion measures the ability to move the wrist joint after injury. |
| Range of Motion: Flexion | 6 months | Range of motion measures the ability to move the wrist joint after injury. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cast That Immobilizes the Thumb Cast that immobilizes the thumb | 31 |
| Cast That Does Not Immobilize the Thumb Cast that does not immobilize the thumb | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | Cast That Immobilizes the Thumb | Cast That Does Not Immobilize the Thumb | Total |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 14 | 42 years STANDARD_DEVIATION 18 | 37.5 years STANDARD_DEVIATION 17 |
| Region of Enrollment United States | 31 participants | 31 participants | 62 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Primary
Extent of Union
The investigators looked at the extent of fracture union after immobilization.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cast That Immobilizes the Thumb | Extent of Union | 70 percentage of union | Standard Deviation 30 |
| Cast That Does Not Immobilize the Thumb | Extent of Union | 85 percentage of union | Standard Deviation 24 |
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).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cast That Immobilizes the Thumb | DASH Questionnaire | 5 units on a scale | Standard Deviation 8 |
| Cast That Does Not Immobilize the Thumb | DASH Questionnaire | 6 units on a scale | Standard Deviation 9 |
Secondary
Grip Strength
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cast That Immobilizes the Thumb | Grip Strength | 40 kilograms | Standard Deviation 21 |
| Cast That Does Not Immobilize the Thumb | Grip Strength | 37 kilograms | Standard Deviation 21 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cast That Immobilizes the Thumb | Modified Mayo Wrist Score | 92 units on a scale | Standard Deviation 9 |
| Cast That Does Not Immobilize the Thumb | Modified Mayo Wrist Score | 87 units on a scale | Standard Deviation 19 |
Secondary
Range of Motion: Extension
Range of motion measures the ability to move the wrist joint after injury.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cast That Immobilizes the Thumb | Range of Motion: Extension | 68 degrees | Standard Deviation 15 |
| Cast That Does Not Immobilize the Thumb | Range of Motion: Extension | 67 degrees | Standard Deviation 14 |
Secondary
Range of Motion: Flexion
Range of motion measures the ability to move the wrist joint after injury.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cast That Immobilizes the Thumb | Range of Motion: Flexion | 76 degrees | Standard Deviation 12 |
| Cast That Does Not Immobilize the Thumb | Range of Motion: Flexion | 72 degrees | Standard Deviation 9 |
Secondary
Range of Motion: Radial Deviation
Range of motion measures the ability to move the wrist joint after injury.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cast That Immobilizes the Thumb | Range of Motion: Radial Deviation | 20 degrees | Standard Deviation 9 |
| Cast That Does Not Immobilize the Thumb | Range of Motion: Radial Deviation | 19 degrees | Standard Deviation 7 |
Secondary
Range of Motion: Ulnar Deviation
Range of motion measures the ability to move the wrist joint after injury.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cast That Immobilizes the Thumb | Range of Motion: Ulnar Deviation | 38 degrees | Standard Deviation 13 |
| Cast That Does Not Immobilize the Thumb | Range of Motion: Ulnar Deviation | 32 degrees | Standard Deviation 8 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cast That Immobilizes the Thumb | Visual Analog Scale for Pain | 1.1 units on a scale | Standard Deviation 1.4 |
| Cast That Does Not Immobilize the Thumb | Visual Analog Scale for Pain | 0.8 units on a scale | Standard Deviation 1.3 |