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Cast Immobilization for Non-Displaced Scaphoid Fractures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00916539
First received: June 5, 2009
Last updated: March 23, 2012
Last verified: March 2012
History of Changes
  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
Non-displaced Scaphoid Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-displaced Scaphoid Fractures: A Clinical Trial of Cast Immobilization Including vs. Excluding the Thumb

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • DASH questionnaire, Gartland and Werley score, Mayo Score, Grip strength, Range of Motion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Study Completion Date: July 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Cast that immobilizes the thumb
2
Cast that does not immobilize the thumb

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Orthopaedic Hand Clinic

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 5, 2009
Last Updated: March 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013