Cast Immobilization for Non-Displaced Scaphoid Fractures

March 1, 2017 updated by: David C. Ring, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusettes General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cast that immobilizes the thumb
Device: Cast that immobilizes the thumb
Cast that immobilizes the thumb
Active Comparator: Cast that does not immobilize the thumb
Device: Cast that does not immobilize the thumb
Cast that does not immobilize the thumb

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH Questionnaire
Time Frame: 6 months
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
Time Frame: 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.
6 months
Grip Strength
Time Frame: 6 months
6 months
Visual Analog Scale for Pain
Time Frame: 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.
6 months
Range of Motion: Flexion
Time Frame: 6 months
Range of motion measures the ability to move the wrist joint after injury.
6 months
Range of Motion: Extension
Time Frame: 6 months
Range of motion measures the ability to move the wrist joint after injury.
6 months
Range of Motion: Ulnar Deviation
Time Frame: 6 months
Range of motion measures the ability to move the wrist joint after injury.
6 months
Range of Motion: Radial Deviation
Time Frame: 6 months
Range of motion measures the ability to move the wrist joint after injury.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: David C Ring, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006P-001424
  • IRB 2006p001424

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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