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Operative Versus Conservative Treatment of Scaphoid Fractures

This study has been completed.
Sponsor:
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00205985
First received: September 14, 2005
Last updated: November 16, 2007
Last verified: November 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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:

ClinicalTrials.gov Identifier: NCT00205985     History of Changes
Other Study ID Numbers: 03-scaph-04
Study First Received: September 14, 2005
Last Updated: November 16, 2007
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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013