NCT00609479

Brief Summary

The purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

January 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 12, 2010

Status Verified

April 1, 2010

Enrollment Period

2.1 years

First QC Date

January 24, 2008

Last Update Submit

April 9, 2010

Conditions

Distal Radius FractureColle´s Fracture

Keywords

Distal radius fractureColle´s fractureInternal fixationExternal fixationDASHPRWE

Outcome Measures

Primary Outcomes (1)

  • DASH-questionnaire

    3 months

Secondary Outcomes (1)

  • PRWE-questionnaire

    3 months

Study Arms (2)

1

EXPERIMENTAL

Internal fixation with Micronail. 41 patients.

Procedure: Osteosynthesis

2

EXPERIMENTAL

External fixation with Hoffmann-II-non-bridging. 41 patients.

Procedure: Osteosynthesis

Interventions

OsteosynthesisPROCEDURE

1. Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12. 2. Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12.

12

Eligibility Criteria

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

You may qualify if:

  • Fracture Older type 2.
  • Fracture Older type 3.

You may not qualify if:

  • Fractures older than 3 weeks.
  • Pregnancy.
  • Seq. after previous fracture.
  • Distal fragments volar cortex \< 10 mm.
  • Open fracture larger than Gustillo 1.
  • Disability due to other illness.
  • Congenital abnormity or injury/disease in the affected extremity.
  • Not capable of mentally/physically to cooperate.
  • Not able to go to followup on the operating hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Regionhospital Herning

Herning, 7400, Denmark

Location

Regionhospital Holstebro

Holstebro, 7500, Denmark

Location

Regionhospital Viborg

Viborg, 8800, Denmark

Location

Related Links

MeSH Terms

Conditions

Wrist Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Kjeld Søballe, MD; PhD; Prof.

    Department of Orthopedics, University of Aarhus, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 12, 2010

Record last verified: 2010-04

Locations

DK(3)