Clinical trial NCT02651779: Internal Plate Fixation vs. Plaster in Complete Articular Distal Radial Fractures
Official title: Internal Plate Fixation vs. Plaster in Complete Articular Distal Radial Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Displaced Complete Articular Distal Radius Fractures
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dijklander Ziekenhuis
name: Maasstad Hospital
name: Maxima Medical Center
name: Catharina Ziekenhuis Eindhoven
name: Rijnland Hospital
name: Diakonessenhuis, Utrecht
name: BovenIJ Hospital
name: Onze Lieve Vrouwe Gasthuis
name: Groene Hart Ziekenhuis
name: Reinier de Graaf Groep
name: Flevoziekenhuis
name: Ziekenhuis Rivierenland
name: Radboud University Medical Center
name: Ziekenhuis Amstelland
name: Medical Center Alkmaar
name: Red Cross Hospital Beverwijk
name: Zaans Medical Center
First posted: 2016-01-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is no consensus about the best treatment for patients with displaced complete articular distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, operative treatment with plate fixation has gained popularity. The aim of this study is to compare the functional outcome of open reduction and plate fixation with closed reduction and plaster immobilisation in adult patients (18-75 years) with displaced complete articular distal radius fractures.

Detailed description: Distal radius fractures account for 17% of all fractures diagnosed. Two third of those fractures are displaced and need to be reduced.

According to the Dutch National Guidelines, displaced distal radius fractures, after adequate reduction confirmed on X-ray, are best treated nonoperatively with cast immobilization. Moreover, the AAOS Clinical Practice Guideline only suggest surgical fixation when the articular step, after reduction, exceeds 2mm. However, both recommendations are based on studies who did not differentiate between intra- and extra-articular distal radius fractures. So, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be made. Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, a rise in use of volar plating has been observed.

The goal of open reduction and plate fixation is to restore articular congruity and axial alignment, and to enable early post-operative movement. Several studies show good radiological and functional results using the volar locking plate in unstable displaced distal radius fractures.

No studies have been carried out to assess whether operative treatment with plate fixation is superior in displaced complete articular distal radius fractures to nonoperative treatment in patients with these fracture type. Therefore, with this randomized controlled trial the investigators wish to determine the difference in functional outcome, assessed with the Patient Related Wrist Evaluation (PRWE), after open reduction and plate fixation compared to nonoperative treatment with closed reduction and cast immobilization.

Eligibility criteria: Inclusion Criteria:

* Patients from 18 - 75 years
* AO type C displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs/CT-scan by a radiologist or trauma surgeon
* Acceptable closed reduction obtained immediately after admission to the Emergency Department (\<12hrs)

Exclusion Criteria:

* Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb
* Open distal radius fractures
* Multiple trauma patients (Injury Severity Score (ISS) ≥16)
* Other fractures of the affected extremity (except from ulnar styloid process)
* Fracture of other wrist
* Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician
* Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget's disease, renal osteodystrophy, osteomalacia)
* Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan's, Ehler Danlos or other related disorders

Primary outcomes:
measure: Wrist pain and disability measured with the Patient Rated Wrist Evaluation (PRWE)
timeFrame: 12 months
Secondary outcomes:
measure: Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 6 weeks and 3, 6 and 12 months
measure: Quality of life measured with the SF-36
timeFrame: 6 weeks and 3, 6 and 12 months
measure: Pain measured with the Visual Analogue Scale (VAS)
timeFrame: 1, 3 and 6 weeks and 3, 6 and 12 months
measure: Range of motion measured with a goniometer
timeFrame: 6 weeks and 3, 6 and 12 months
measure: Grip strength measured with a dynamometer
timeFrame: 6 weeks and 3, 6 and 12 months
measure: Number of patients with loss of reduction
timeFrame: 1, 3 and 6 weeks and 3, 6 and 12 months
measure: Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire
timeFrame: 6 weeks and 3, 6 and 12 months
measure: Number of complications in both treatment groups
timeFrame: 1, 3 and 6 weeks and 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
affiliation: Maasstad Hospital
name: Niels W.L. Schep, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mulders MAM, Walenkamp MMJ, Goslings JC, Schep NWL. Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial. BMC Musculoskelet Disord. 2016 Feb 9;17:68. doi: 10.1186/s12891-016-0925-y.