Unstable Fractures of the Distal Radius: Trial of Volar Plate Versus Dorsal Nail Plate Fixation (RADIUS)
Primary Purpose
Distal Radius Fractures
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Volar plate
Dorsal nail plate
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fractures focused on measuring Fracture, Radius, Surgery, Osteosynthesis
Eligibility 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
Sites / Locations
- Asker and Baerum Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
DVR
DNP
Arm Description
Volar plate
Dorsal nail plate
Outcomes
Primary Outcome Measures
DASH score
Secondary Outcome Measures
PRWE score
EQ-5D score
Grip strength
Radiological result
Pain VAS score (1-10)
Full Information
NCT ID
NCT00848263
First Posted
February 19, 2009
Last Updated
November 17, 2014
Sponsor
Sykehuset Asker og Baerum
1. Study Identification
Unique Protocol Identification Number
NCT00848263
Brief Title
Unstable Fractures of the Distal Radius: Trial of Volar Plate Versus Dorsal Nail Plate Fixation
Acronym
RADIUS
Official Title
Unstable Fractures of the Distal Radius: Randomised Controlled Trial of Volar Plate Versus Dorsal Nail Plate Fixation.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset Asker og Baerum
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
Fracture, Radius, Surgery, Osteosynthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DVR
Arm Type
Active Comparator
Arm Description
Volar plate
Arm Title
DNP
Arm Type
Active Comparator
Arm Description
Dorsal nail plate
Intervention Type
Procedure
Intervention Name(s)
Volar plate
Other Intervention Name(s)
Hand Innovation, DePuy
Intervention Description
Treatment with a volar plate (DVR) inserted through a volar incision of 8-10 cm over the distal radius (Henry's approach).
Intervention Type
Procedure
Intervention Name(s)
Dorsal nail plate
Other Intervention Name(s)
Hand Innovation, DePuy
Intervention Description
Treatment with a dorsal nail plate (DNP) inserted through a 3-4 cm dorsal incision.
Primary Outcome Measure Information:
Title
DASH score
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
PRWE score
Time Frame
52 weeks
Title
EQ-5D score
Time Frame
52 weeks
Title
Grip strength
Time Frame
52 weeks
Title
Radiological result
Time Frame
52 weeks
Title
Pain VAS score (1-10)
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asbjørn Hjall, M.D.
Organizational Affiliation
Asker and Baerum hospital, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Asker and Baerum Hospital
City
Baerum
State/Province
Rud
ZIP/Postal Code
1309
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Unstable Fractures of the Distal Radius: Trial of Volar Plate Versus Dorsal Nail Plate Fixation
We'll reach out to this number within 24 hrs