Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wender Figved, Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier:
NCT00848263
First received: February 19, 2009
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Distal Radius Fractures
 Procedure: Volar plate
Procedure: Dorsal nail plate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Unstable Fractures of the Distal Radius: Randomised Controlled Trial of Volar Plate Versus Dorsal Nail Plate Fixation.

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Sykehuset Asker og Baerum:

Primary Outcome Measures:
  • DASH score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PRWE score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • EQ-5D score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Radiological result [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pain VAS score (1-10) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Hand Innovation, DePuy

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848263

Locations
Norway
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
  More Information

No publications provided

Responsible Party: Wender Figved, Md PhD, Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier: NCT00848263     History of Changes
Other Study ID Numbers: RADIUS-DVR-DNP
Study First Received: February 19, 2009
Last Updated: February 8, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sykehuset Asker og Baerum:
Fracture
Radius
Surgery
Osteosynthesis

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on May 19, 2013