Unstable Fractures of the Distal Radius: Trial of Volar Plate Versus Dorsal Nail Plate Fixation (RADIUS)
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|ClinicalTrials.gov Identifier: NCT00848263|
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : November 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fractures||Procedure: Volar plate Procedure: Dorsal nail plate||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Unstable Fractures of the Distal Radius: Randomised Controlled Trial of Volar Plate Versus Dorsal Nail Plate Fixation.|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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
- DASH score [ Time Frame: 52 weeks ]
- PRWE score [ Time Frame: 52 weeks ]
- EQ-5D score [ Time Frame: 52 weeks ]
- Grip strength [ Time Frame: 52 weeks ]
- Radiological result [ Time Frame: 52 weeks ]
- Pain VAS score (1-10) [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848263
|Asker and Baerum Hospital|
|Baerum, Rud, Norway, 1309|
|Study Chair:||Asbjørn Hjall, M.D.||Asker and Baerum hospital, Norway|