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

Distal Radius Fractures Clinical Trial

— RADIUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848263
• Other study ID #: RADIUS-DVR-DNP
• Status: Completed
• Phase: N/A
• First received: February 19, 2009
• Last updated: November 17, 2014
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: Sykehuset Asker og Baerum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Volar plate
Treatment with a volar plate (DVR) inserted through a volar incision of 8-10 cm over the distal radius (Henry's approach).
• Dorsal nail plate
Treatment with a dorsal nail plate (DNP) inserted through a 3-4 cm dorsal incision.

Locations

Country	Name	City	State
Norway	Asker and Baerum Hospital	Baerum	Rud

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Asker og Baerum

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH score		52 weeks	No
Secondary	PRWE score		52 weeks	No
Secondary	EQ-5D score		52 weeks	No
Secondary	Grip strength		52 weeks	No
Secondary	Radiological result		52 weeks	No
Secondary	Pain VAS score (1-10)		52 weeks	No