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Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly (VOCAL)

D

Danderyd Hospital

Status

Unknown

Conditions

Wrist Fracture
Fracture of the Distal Radius

Treatments

Procedure: open reduction and internal fixation with a volar plate
Procedure: closed reduction and plaster treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01268397
Wilcke-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

ORIF
Active Comparator group
Description:
Open reduction and internal fixation with a volar plate
Treatment:
Procedure: open reduction and internal fixation with a volar plate
plaster treatment
Active Comparator group
Description:
Closed reduction and plaster treatment
Treatment:
Procedure: closed reduction and plaster treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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