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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00916539
Other study ID # 2006P-001424
Secondary ID IRB 2006p001424
Status Active, not recruiting
Phase N/A
First received June 5, 2009
Last updated September 22, 2015
Start date July 2007
Est. completion date January 2016

Study information

Verified date September 2015
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date January 2016
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Massachusettes General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary DASH questionnaire, Gartland and Werley score, Mayo Score, Grip strength, Range of Motion 6 months No