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NCT00205985 Clinical Trial

Operative Versus Conservative Treatment of Scaphoid Fractures

Scaphoid Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00205985
Other study ID # 03-scaph-04
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2003
Est. completion date April 2006

Study information
Verified date August 2020
Source AO Innovation Translation Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Scaphoid screw
Conservative treatment versus application of scaphoid screw

Locations
Country Name City State
Germany Klinikum der Philipps Universitaet Marburg Marburg

Sponsors (1)
Lead Sponsor Collaborator
AO Clinical Investigation and Publishing Documentation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pfeiffer BM, Nübling M, Siebert HR, Schädel-Höpfner 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time to return to previous activity level
Primary Time to return to full work and household duties
Secondary DASH
Secondary SF-36
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Completed NCT04776551 - Percutaneous Fixation of Acute Scaphoid Fractures N/A