NCT00205985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

First QC Date

September 14, 2005

Last Update Submit

August 12, 2020

Conditions

Scaphoid Fracture

Keywords

Return to workScaphoid fractureOperative treatmentActivity level

Outcome Measures

Primary Outcomes (2)

  • Time to return to previous activity level

  • Time to return to full work and household duties

Secondary Outcomes (2)

  • DASH

  • SF-36

Interventions

Scaphoid screwDEVICE

Conservative treatment versus application of scaphoid screw

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mature skeleton
  • Isolated, acute complete fracture of the mid third of the scaphoid

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Philipps Universitaet Marburg

Marburg, 35037, Germany

Location

Related Publications (1)

  • 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.

    PMID: 16689987RESULT

Study Officials

  • Markus Schaedel-Hoepfner, Prof. MD

    Klinikum der Universitaet Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

December 1, 2003

Study Completion

April 1, 2006

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

DE(1)