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

Not Applicable

Completed

• Conditions: Distal Radius Fractures
• Interventions: Procedure: Volar plate; Procedure: Dorsal nail plate

• Registration Number: NCT00848263
• Lead Sponsor: Sykehuset Asker og Baerum

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DVR	Volar plate	Volar plate
DNP	Dorsal nail plate	Dorsal nail plate

Primary Outcome Measures

Name	Time	Method
DASH score	52 weeks

Secondary Outcome Measures

Name	Time	Method
EQ-5D score	52 weeks
Pain VAS score (1-10)	52 weeks
PRWE score	52 weeks
Radiological result	52 weeks
Grip strength	52 weeks

Trial Locations

Locations (1)

Asker and Baerum Hospital; 🇳🇴 Baerum, Rud, Norway