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

Sponsor

Sykehuset Asker og Baerum (Other)

Overall Status

Completed

CT.gov ID

NCT00848263

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fractures	Procedure: Volar plate Procedure: Dorsal nail plate	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DVR Volar plate	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). Other Names: Hand Innovation, DePuy
Active Comparator: DNP Dorsal nail plate	Procedure: Dorsal nail plate Treatment with a dorsal nail plate (DNP) inserted through a 3-4 cm dorsal incision. Other Names: Hand Innovation, DePuy

Arm

Intervention/Treatment

Active Comparator: DVR

Volar plate

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).

Other Names:

Hand Innovation, DePuy

Active Comparator: DNP

Dorsal nail plate

Procedure: Dorsal nail plate

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

Other Names:

Hand Innovation, DePuy

Outcome Measures

Primary Outcome Measures

DASH score [52 weeks]

Secondary Outcome Measures

PRWE score [52 weeks]
EQ-5D score [52 weeks]
Grip strength [52 weeks]
Radiological result [52 weeks]
Pain VAS score (1-10) [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asker and Baerum Hospital	Baerum	Rud	Norway	1309

Sponsors and Collaborators

Sykehuset Asker og Baerum

Investigators

Study Chair: Asbjørn Hjall, M.D., Asker and Baerum hospital, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wender Figved, Md PhD, Sykehuset Asker og Baerum

ClinicalTrials.gov Identifier:

NCT00848263

Other Study ID Numbers:

RADIUS-DVR-DNP

First Posted:

Feb 20, 2009

Last Update Posted:

Nov 19, 2014

Last Verified:

Nov 1, 2014

Keywords provided by Wender Figved, Md PhD, Sykehuset Asker og Baerum

Additional relevant MeSH terms:

Fractures, Bone

Radius Fractures

Study Results

No Results Posted as of Nov 19, 2014