Operative Versus Conservative Treatment of Scaphoid Fractures
August 12, 2020 updated by: AO Clinical Investigation and Publishing Documentation
Comparison of Time to Return to Previous Activity Between Operative Treatment and Cast Immobilization of Complete Fracture of the Middle Part of the Scaphoid Without Dislocation
The aim of this study is to compare the time to return to previous activity
level between operative treatment and non-operative cast immobilization of
patients with an acute complete fracture of the middle part of the scaphoid,
without any dislocation or comminution visible CT-scan.
Study Overview
Study Type
Interventional
Enrollment
100
Phase
- Phase 4
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
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Marburg, Germany, 35037
- Klinikum der Philipps Universitaet Marburg
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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:
- Mature skeleton
- Isolated, acute complete fracture of the mid third of the scaphoid
Exclusion Criteria:
- acute fractures of both hands
- one hand missing
- other injuries than scaphoid fractures
- rheumatoid, osteoarthritis or polyarthritis
- previous soft tissue injuries of the hand
- drug or alcohol abuse
- participant in trial during the previous month
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Time to return to previous activity level
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Time to return to full work and household duties
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Secondary Outcome Measures
Outcome Measure |
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SF-36
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DASH
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Markus Schaedel-Hoepfner, Prof. MD, Klinikum der Universitaet Marburg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
December 1, 2003
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Actual)
August 14, 2020
Last Update Submitted That Met QC Criteria
August 12, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-scaph-04
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.