Operative Versus Conservative Treatment of Scaphoid Fract... | NCT00205985

Studies
Operative Versus Conservative Treatment of Scaphoid Fractures

NCT00205985

Sponsor

AO Clinical Investigation and Publishing Documentation

Status

Completed

Last Update Posted

Aug 14, 2020Actual

Enrollment

100

Phase

Phase 4

Conditions

Scaphoid Fracture

Interventions

Scaphoid screw

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2020

Last Update Posted Date

Aug 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Scaphoid screw	Device	Conservative treatment versus application of scaphoid screw

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to return to previous activity level
Time to return to full work and household duties

Secondary Outcomes

Measure	Description	Time Frame
DASH
SF-36

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markus Schaedel-Hoepfner, Prof. MD	Klinikum der Universitaet Marburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum der Philipps Universitaet Marburg		Marburg		35037	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16689987	Result	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.