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Unstable Fractures of the Distal Radius: Trial of Volar Plate Versus Dorsal Nail Plate Fixation

NCT ID: NCT00848263

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-12-31

Brief Summary

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Fractures of the distal radius are one of the most common orthopaedic injuries and are associated with a high complication rate. There is a lack of clinical trials comparing the different treatment modalities of fractures of the distal radius. The purpose of this randomized trial is to assess differences in functional outcome, radiological results, and complication rate in patients 55 years and older with an unstable displaced fracture of the distal radius without articular involvement treated with a dorsal nail plate or a volar plate.

Detailed Description

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Surgical treatment is needed for distal radius fractures that can not be treated with a simple plaster cast, and is indicated in a substantial amount of these patients. There is a well known correlation between a good anatomical result and a good functional outcome for the patient. The most common methods for operative fixation are external fixation with a metal frame, percutaneous pin fixation, and open surgery with insertion of a metal plate and screws on the dorsal or the volar side of the fracture. Biomechanical studies have shown differences in mechanical stability between different plate fixation systems.

The investigators are conducting this randomized trial to investigate the differences in outcome after treatment with a DVR volar plate and a DNP dorsal nail plate. The DVR volar plate follows the same principles of fixation as other volar plates using locking screws and/or pegs. It has smooth or threaded pegs that are multidirectionally placed in the distal part of the plate. The dorsal nail plate (DNP) is a relatively new implant that is inserted through a less invasive technique, with a minimum of soft tissue exposure. It is inserted through a 3-4 cm long incision on the dorsal side of the wrist and is introduced into the medullary canal. It is fixed with screws on the proximal (nail) side of the fracture and threaded or smooth locked multidirectional pegs on the distal (plate) side of the fracture. It has been suggested as a good alternative to regular plate fixation where less invasive surgery is desired. Clinical patient series have been published showing good clinical results.

There are no clinical trials comparing these two types of treatment. Therefore the investigators want to conduct a randomised controlled trial, with the purpose of finding potential differences in functional outcome for the patients.

Conditions

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Distal Radius Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DVR

Volar plate

Group Type ACTIVE_COMPARATOR

Volar plate

Intervention Type PROCEDURE

Treatment with a volar plate (DVR) inserted through a volar incision of 8-10 cm over the distal radius (Henry's approach).

DNP

Dorsal nail plate

Group Type ACTIVE_COMPARATOR

Dorsal nail plate

Intervention Type PROCEDURE

Treatment with a dorsal nail plate (DNP) inserted through a 3-4 cm dorsal incision.

Interventions

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Volar plate

Treatment with a volar plate (DVR) inserted through a volar incision of 8-10 cm over the distal radius (Henry's approach).

Intervention Type PROCEDURE

Dorsal nail plate

Treatment with a dorsal nail plate (DNP) inserted through a 3-4 cm dorsal incision.

Intervention Type PROCEDURE

Other Intervention Names

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Hand Innovation, DePuy Hand Innovation, DePuy

Eligibility Criteria

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Inclusion Criteria

* Unstable dorsally displaced fracture of the distal radius without articular involvement
* Age 55 years or older

Exclusion Criteria

* Previous fracture of the same wrist
* More than one acute fracture (except the ulnar styloid process)
* Open fracture
* Mental impairment or unable to understand and sign an informed consent
* Fracture older than 14 days
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset Asker og Baerum

OTHER

Sponsor Role lead

Responsible Party

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Wender Figved

Md PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asbjørn Hjall, M.D.

Role: STUDY_CHAIR

Asker and Baerum hospital, Norway

Locations

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Asker and Baerum Hospital

Baerum, Rud, Norway

Site Status

Countries

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Norway

Other Identifiers

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RADIUS-DVR-DNP

Identifier Type: -

Identifier Source: org_study_id