Clinical trial NCT02030496: Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures
Official title: Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Displaced Extra-articular Distal Radius Fractures
Keywords: distal radius fractures
Closed reduction
Open reduction internal fixation
Volar plate
Redislocation
Unstable fracture
Extra-articular fracture
Colles fracture
Barton fracture
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouwe Gasthuis
name: Diakonessenhuis, Utrecht
name: Elkerliek Hospital
name: Groene Hart Ziekenhuis
name: Dijklander Ziekenhuis
name: Reinier de Graaf Groep
name: Maasstad Hospital
name: BovenIJ Hospital
name: Rijnland Hospital
name: Flevoziekenhuis
name: Radboud University Medical Center
name: Maxima Medical Center
name: Zaans Medisch Centrum
First posted: 2014-01-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND:

Fractures of the distal radius are common and account for an estimated 17% of all fractures diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal radius fractures are considered to be relatively harmless, inadequate treatment may result in impaired function of the wrist. The consequences of post-traumatic loss of function are comprehensive, both on an individual and a social level, and have long been underestimated. Despite the substantial implications, no evidence-based treatment method yet exists. Good results have been described both in patients treated conservatively and surgically. Nevertheless, 60% of all fractures redislocate after conservative treatment at which point surgical reduction and fixation is the treatment of choice. Recently, the use of volar locking plates has become more popular. This type of osteosynthesis employs a volar approach to the wrist and provides immediate stable fixation of the reduced fracture. This stability allows for early mobilisation and may therefore result in an improved regain of function. The aim of this study is to compare the functional outcome following surgical reduction and fixation with a volar locking plate with the functional outcome following closed reduction and plaster immobilisation at one year follow-up in patients with displaced extra-articular distal radius fractures.

DESIGN:

This single blinded randomised controlled trial will randomise between open reduction and internal fixation with a volar locking plate (intervention group) and closed reduction followed by plaster immobilisation (control group). The study population will consist of all consecutive adult patients who are diagnosed with a displaced extra-articular distal radius fracture which has been adequately reduced at the Emergency Department. The primary outcome (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score (DASH). Since the treatment allocated involves a surgical procedure, randomisation status will not be blinded. However, the researcher assessing the outcome at one year will be unaware of the treatment allocation. In total, 90 patients will be included in this trial which will be conducted in the Academic Medical Centre Amsterdam and its partners of the regional trauma care network.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years and ≤ 75 years
* Extra-articular (AO type A) displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs by a radiologist or trauma surgeon.
* Acceptable closed reduction obtained according to current Dutch guidelines within 12 hours after presentation at the Emergency Department (ED).

Exclusion Criteria:

* Open distal radius fractures
* Multiple trauma patients (Injury Severity Score (ISS) ≥16)
* Other fractures of the affected extremity
* Patients with impaired wrist function prior to injury due to arthritis/neurological disorders of the upper limb
* Patient suffering from disorders of bone metabolism, connective tissue or (joint) hyperflexibility.
* Insufficient comprehension of the Dutch language to understand the treatment information and informed consent forms as judged by the attending physician.

Primary outcomes:
measure: Wrist function/pain/disability at one year assessed with DASH score
timeFrame: At12 months follow up
Secondary outcomes:
measure: Wrist function at one year assessed with PRWE score
timeFrame: 6 weeks, three, six and 12 months
measure: Quality of Life
timeFrame: 6 weeks, three, six and 12 months
measure: Pain
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Patient satisfaction
timeFrame: at one year
measure: Range of motion
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Grip strength
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Radiological parameters
timeFrame: At one year
measure: Complications
timeFrame: 1 week, 2-3 weeks, 6 weeks, 3, 6 and 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: J. Carel Goslings, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: