NCT01062997

Brief Summary

A randomized, prospective comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 \& C3. Hypothesis: There is no significant difference in using volar plates compared to Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 \& C3 as evaluated by a Quick-DASH score at 24 months follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

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

September 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

6.3 years

First QC Date

February 4, 2010

Last Update Submit

August 6, 2016

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

  • Quick-DASH

    2 year follow-up

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture

You may qualify if:

  • All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA).

You may not qualify if:

  • Gustillo-Anderson type III open fractures
  • Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
  • Dementia
  • Congenital anomaly
  • Bilateral radius fracture
  • Pathological fracture other than osteoporotic fracture
  • Congenital bone disease (for example osteogenesis imperfecta)
  • Age below 18 and above 70
  • Disabling nury to other parts og the movement apparatus at the same time as the current injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Sykehusveien 25, Nordbyhagen, Lorenskog, 1478, Norway

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-student

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

NO(1)