Cast Immobilization for Non-Displaced Scaphoid Fractures

Not Applicable

Completed

• Conditions: Non-displaced Scaphoid Fractures
• Interventions: Device: Cast that immobilizes the thumb; Device: Cast that does not immobilize the thumb

• Registration Number: NCT00916539
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Primary Completion: 2012-01
• Study Completion: 2013-12
• Results First Submitted: 2016-12-20
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-01
• Last Update Submitted: 2017-03-01
• Results First Posted: 2017-04-12
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cast that immobilizes the thumb	Cast that immobilizes the thumb	Cast that immobilizes the thumb
Cast that does not immobilize the thumb	Cast that does not immobilize the thumb	Cast that does not immobilize the thumb

Primary Outcome Measures

Name	Time	Method
Extent of Union	10 weeks	The investigators looked at the extent of fracture union after immobilization.

Secondary Outcome Measures

Name	Time	Method
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).
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.
Range of Motion: Flexion	6 months	Range of motion measures the ability to move the wrist joint after injury.
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.

Trial Locations

Locations (1)

Massachusettes General Hospital; 🇺🇸 Boston, Massachusetts, United States