NCT01778673

Brief Summary

Background: Although fractures of the distal radius are the most common skeletal injury, the utility of the available classification systems to predict fracture stability is limited. We studied if cortical comminution and intra-articular involvement can assess instability in fractures of the distal radius. Methods: A prospective multicenter study was conducted. Distal radius fractures in 417 skeletally mature patients (428 fractures) were studied. Fractures were divided into osteoporotic or non-osteoporotic according to age of the patients. Antero-posterior and lateral plain radiographs determined if the fractures were minimally displaced or displaced. The fracture patterns were evaluated depending on the presence and the site of cortical comminution and intra-articular involvement according to a new classification system (Buttazzoni classification). Minimally displaced fractures were treated with cast immobilization. Displaced fractures underwent closed reduction with subsequent cast immobilization. Radiographs were obtained after reduction, at 10-14 days and after 3 months. Displacement was classified as primary instability, secondary instability or late instability. Endpoints were union of the fracture or re-displacement. Results: Volarly comminuted fractures (Buttazzoni 4) displaced in 96 %, intra-articular fractures (Buttazzoni 3) in 72%, dorsally comminuted fractures (Buttazzoni 2) in 73% and non-comminuted (Buttazzoni 1) in 16 % of the cases. One third of the initially minimally displaced fractures did not maintain acceptable alignment. All initially displaced volarly comminuted fractures were unstable. In both initially displaced and minimally displaced fractures, cortical comminution and intra-articular involvement were predictive for primary, secondary and late instability. Conclusions: Cortical comminution and intra-articular involvement seem to be valuable instruments for assessing stability at initial presentation of distal radius fractures. Level of Evidence: Level I, prospective multicenter study. Prognostic study.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

January 24, 2013

Last Update Submit

January 24, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fracture displacement

    3 months

Study Arms (2)

Distal radius fractures Sundsvall Hospital

Procedure: Cast immobilization

Distal radius fractures Östersund Hospital.

Procedure: Cast immobilization

Interventions

Distal radius fractures Sundsvall HospitalDistal radius fractures Östersund Hospital.

Eligibility Criteria

Age15 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

community sample

You may qualify if:

  • Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna.

You may not qualify if:

  • Dementia, previous fracture to the ipsilateral wrist, open fracture, other concomitant or existing damage or injury to the wrist, Galeazzi fracture, rheumatoid arthritis, alcohol or drug abuse and neurologic impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of orthopedic surgery Sundsvall Hospital

Sundsvall, Sundsvall, 851 86, Sweden

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 29, 2013

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations