Clinical trial NCT00848263: Unstable Fractures of the Distal Radius: Trial of Volar Plate Versus Dorsal Nail Plate Fixation
Official title: Unstable Fractures of the Distal Radius: Randomised Controlled Trial of Volar Plate Versus Dorsal Nail Plate Fixation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fractures
Keywords: Fracture
Radius
Surgery
Osteosynthesis
Lead sponsor: Sykehuset Asker og Baerum
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: DASH score
timeFrame: 52 weeks
Secondary outcomes:
measure: PRWE score
timeFrame: 52 weeks
measure: EQ-5D score
timeFrame: 52 weeks
measure: Grip strength
timeFrame: 52 weeks
measure: Radiological result
timeFrame: 52 weeks
measure: Pain VAS score (1-10)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Baerum
country: Norway
facility: Asker and Baerum Hospital
state: Rud
Study officials:
affiliation: Asker and Baerum hospital, Norway
name: Asbjørn Hjall, M.D.
role: STUDY_CHAIR
References: