Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01268397

Acronym

VOCAL

Enrollment

Registered

2010-12-30

Start date

2009-12-31

Completion date

2019-12-31

Last updated

2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture of the Distal Radius, Wrist Fracture

Keywords

elderly, wrist fracture, fracture of the distal radius, volar plate, plaster cast

Brief summary

The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

Detailed description

We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.

Interventions

PROCEDUREopen reduction and internal fixation with a volar plate

flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion

PROCEDUREclosed reduction and plaster treatment

closed reduction, below elbow plaster cast, semicircular for 5 week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

Healthy volunteers

Inclusion criteria

* Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).

Exclusion criteria

* Previous displaced fracture of the distal radius. * Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ\<5), psychiatric illness, alcohol abuse).

Design outcomes

Primary

Measure	Time frame
patient-perceived disability measured by the PRWE and DASH questionnaires	one year after wrist fracture

Secondary

Measure	Time frame
impairments (grip strength and range of motion compared with the uninjured wrist)	one year after wrist fracture

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026