Operative Versus Conservative Treatment of Scaphoid Fractures

Sponsor

AO Clinical Investigation and Publishing Documentation (Other)

Overall Status

Completed

CT.gov ID

NCT00205985

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Dec 1, 2003

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Klinikum der Philipps Universitaet Marburg	Marburg		Germany	35037

Sponsors and Collaborators

AO Clinical Investigation and Publishing Documentation

Investigators

Principal Investigator: Markus Schaedel-Hoepfner, Prof. MD, Klinikum der Universitaet Marburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00205985

Other Study ID Numbers:

03-scaph-04

First Posted:

Sep 21, 2005

Last Update Posted:

Aug 14, 2020

Last Verified:

Aug 1, 2020

Keywords provided by , ,

Additional relevant MeSH terms:

Fractures, Bone

Study Results

No Results Posted as of Aug 14, 2020