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Operative Versus Conservative Treatment of Scaphoid Fractures

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.
ClinicalTrials.gov Identifier: NCT00205985
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 19, 2007
Information provided by:
AO Clinical Investigation and Documentation

Brief Summary:

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 or disease Intervention/treatment Phase
Scaphoid Fracture Device: Scaphoid screw Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : December 2003
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Intervention Details:
    Device: Scaphoid screw
    Conservative treatment versus application of scaphoid screw

Primary Outcome Measures :
  1. Time to return to previous activity level
  2. Time to return to full work and household duties

Secondary Outcome Measures :
  1. DASH
  2. SF-36

Information from the National Library of Medicine

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

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

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

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

ClinicalTrials.gov Identifier: NCT00205985     History of Changes
Other Study ID Numbers: 03-scaph-04
First Posted: September 21, 2005    Key Record Dates
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