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Operative Versus Conservative Treatment of Scaphoid Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205985
First Posted: September 21, 2005
Last Update Posted: November 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AO Clinical Investigation and Documentation
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Time to return to previous activity level
  • Time to return to full work and household duties

Secondary Outcome Measures:
  • DASH
  • SF-36

Estimated Enrollment: 100
Study Start Date: December 2003
Study Completion Date: April 2006
Intervention Details:
    Device: Scaphoid screw
    Conservative treatment versus application of scaphoid screw
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205985


Locations
Germany
Klinikum der Philipps Universitaet Marburg
Marburg, Germany, 35037
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Markus Schaedel-Hoepfner, Prof. MD Klinikum der Universitaet Marburg
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00205985     History of Changes
Other Study ID Numbers: 03-scaph-04
First Submitted: September 14, 2005
First Posted: September 21, 2005
Last Update Posted: November 19, 2007
Last Verified: November 2007

Keywords provided by AO Clinical Investigation and Documentation:
Return to work
Scaphoid fracture
Operative treatment
Activity level

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries