Operative Versus Conservative Treatment of Scaphoid Fractures - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

November 16, 2007

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Time to return to previous activity level
Time to return to full work and household duties

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00205985 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

DASH
SF-36

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Operative Versus Conservative Treatment of Scaphoid Fractures

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Scaphoid Fracture

Intervention ^ICMJE

Device: Scaphoid screw

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00205985

Responsible Party

Study ID Numbers ^ICMJE

03-scaph-04

Study Sponsor ^ICMJE

AO Clinical Investigation and Documentation

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Markus Schaedel-Hoepfner, Prof. MD

Klinikum der Universitaet Marburg

Information Provided By

AO Clinical Investigation and Documentation

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP