Unstable Fractures of the Distal Radius: Trial of Volar Plate Versus Dorsal Nail Plate Fixation (RADIUS)
|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.|
- DASH score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||February 2009|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: DVR
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848263
|Asker and Baerum Hospital|
|Baerum, Rud, Norway, 1309|
|Study Chair:||Asbjørn Hjall, M.D.||Asker and Baerum hospital, Norway|