Operative Versus Conservative Treatment of Scaphoid Fractures

NCT ID: NCT00205985

Last Updated: 2020-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-04-30

Brief Summary

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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

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Conditions

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Scaphoid Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Scaphoid screw

Conservative treatment versus application of scaphoid screw

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Principal Investigators

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Markus Schaedel-Hoepfner, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universitaet Marburg

Locations

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Klinikum der Philipps Universitaet Marburg

Marburg, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1186/1471-2474-7-41.

Reference Type RESULT
PMID: 16689987 (View on PubMed)

Other Identifiers

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03-scaph-04

Identifier Type: -

Identifier Source: org_study_id

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