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Operative Versus Conservative Treatment of Scaphoid Fractures

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   Dislocations    Fractures   

U.S. FDA Resources

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

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 of Results:
Pfeiffer BM, Nubling M, Siebert HR, Schadel-Hopfner M. A prospective multi-center cohort study of acute non-displaced fractures of the scaphoid: operative versus non-operative treatment [NCT00205985]. BMC Musculoskelet Disord. 2006 May 11;7:41.
 

Study ID Numbers:   03-scaph-04
First Received:   September 14, 2005
Last Updated:   November 16, 2007
ClinicalTrials.gov Identifier:   NCT00205985
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Dislocations
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on September 05, 2008

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