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Completed

NCT Number: NCT00848263

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asker and Baerum Hospital

Baerum, Rud, 1309, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volar plate

Procedure

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

Other names: Hand Innovation, DePuy

Dorsal nail plate

Procedure

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

Other names: Hand Innovation, DePuy

Primary outcomes

  1. DASH score

    Time frame: 52 weeks

Secondary outcomes

  1. PRWE score

    Time frame: 52 weeks

  2. EQ-5D score

    Time frame: 52 weeks

  3. Grip strength

    Time frame: 52 weeks

  4. Radiological result

    Time frame: 52 weeks

  5. Pain VAS score (1-10)

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Sykehuset Asker og Baerum

Other

Registry information

Official study title

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

Acronym: RADIUS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2009
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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