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Operative Versus Conservative Treatment of Scaphoid Fractures

Primary Purpose

Scaphoid Fracture

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Scaphoid screw
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scaphoid Fracture focused on measuring Return to work, Scaphoid fracture, Operative treatment, Activity level

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Klinikum der Philipps Universitaet Marburg

Outcomes

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

Full Information

First Posted
September 14, 2005
Last Updated
August 12, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
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1. Study Identification

Unique Protocol Identification Number
NCT00205985
Brief Title
Operative Versus Conservative Treatment of Scaphoid Fractures
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 Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AO Clinical Investigation and Publishing Documentation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scaphoid Fracture
Keywords
Return to work, Scaphoid fracture, Operative treatment, Activity level

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Scaphoid screw
Intervention Description
Conservative treatment versus application of scaphoid screw
Primary Outcome Measure Information:
Title
Time to return to previous activity level
Title
Time to return to full work and household duties
Secondary Outcome Measure Information:
Title
DASH
Title
SF-36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Schaedel-Hoepfner, Prof. MD
Organizational Affiliation
Klinikum der Universitaet Marburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum der Philipps Universitaet Marburg
City
Marburg
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16689987
Citation
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.
Results Reference
result

Learn more about this trial

Operative Versus Conservative Treatment of Scaphoid Fractures

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