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| Sponsor: | AO Clinical Investigation and Documentation |
|---|---|
| Information provided by: | AO Clinical Investigation and Documentation |
| ClinicalTrials.gov Identifier: | NCT00205985 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Scaphoid Fracture |
Device: Scaphoid screw |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2003 |
| Study Completion Date: | April 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Klinikum der Philipps Universitaet Marburg | |
| Marburg, Germany, 35037 | |
| Principal Investigator: | Markus Schaedel-Hoepfner, Prof. MD | Klinikum der Universitaet Marburg |
More Information
| Study ID Numbers: | 03-scaph-04 |
| Study First Received: | September 14, 2005 |
| Last Updated: | November 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00205985 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Return to work Scaphoid fracture Operative treatment Activity level |
|
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |