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Cast Immobilization for Non-Displaced Scaphoid Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916539
First Posted: June 9, 2009
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
  Purpose
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.

Condition Intervention
Non-displaced Scaphoid Fractures Device: Cast that immobilizes the thumb Device: Cast that does not immobilize the thumb

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-displaced Scaphoid Fractures: A Clinical Trial of Cast Immobilization Including vs. Excluding the Thumb

Resource links provided by NLM:


Further study details as provided by David C. Ring, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Extent of Union [ Time Frame: 10 weeks ]
    The investigators looked at the extent of fracture union after immobilization.


Secondary Outcome Measures:
  • 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).

  • 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.

  • Grip Strength [ Time Frame: 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.

  • Range of Motion: Flexion [ Time Frame: 6 months ]
    Range of motion measures the ability to move the wrist joint after injury.

  • Range of Motion: Extension [ Time Frame: 6 months ]
    Range of motion measures the ability to move the wrist joint after injury.

  • Range of Motion: Ulnar Deviation [ Time Frame: 6 months ]
    Range of motion measures the ability to move the wrist joint after injury.

  • Range of Motion: Radial Deviation [ Time Frame: 6 months ]
    Range of motion measures the ability to move the wrist joint after injury.


Enrollment: 62
Study Start Date: July 2007
Study Completion Date: December 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cast that immobilizes the thumb
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
Cast that does not immobilize the thumb
Device: Cast that does not immobilize the thumb
Cast that does not immobilize the thumb

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916539


Locations
United States, Massachusetts
Massachusettes General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David C Ring, MD Massachusetts General Hospital
  More Information

Responsible Party: David C. Ring, MD, Principal Investigator; Director of Research, Hand Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00916539     History of Changes
Other Study ID Numbers: 2006P-001424
IRB 2006p001424
First Submitted: June 5, 2009
First Posted: June 9, 2009
Results First Submitted: December 20, 2016
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Calpastatin
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action