Cast Immobilization for Non-Displaced Scaphoid Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014