Cast Immobilization for Non-Displaced Scaphoid Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Non-displaced Scaphoid Fractures: A Clinical Trial of Cast Immobilization Including vs. Excluding the Thumb

Conditions
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Non-displaced Scaphoid Fractures

Intervention / Treatment
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* Device: Cast that immobilizes the thumb
* Device: Cast that does not immobilize the thumb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Isolated fracture of the scaphoid No displacement of the scaphoid fracture on CT scan Exclusion Criteria: Associated ipsilateral ligament injury or fracture Pregnant Patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cast that immobilizes the thumb<br>Cast that immobilizes the thumb | Device: Cast that immobilizes the thumb<br>* Cast that immobilizes the thumb<br>|
| Active Comparator: Cast that does not immobilize the thumb<br>Cast that does not immobilize the thumb | Device: Cast that does not immobilize the thumb<br>* Cast that does not immobilize the thumb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Union | The investigators looked at the extent of fracture union after immobilization. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |