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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Academic Medical Center
Amsterdam, Netherlands
Wrist pain and disability measured with the Patient Rated Wrist Evaluation (PRWE)
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of three subscales: Pain, Function and Cosmetics.
Time frame: 12 months
Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire
The Disabilities of the Arm, Shoulder and Hand (DASH) score is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.
Time frame: 6 weeks and 3, 6 and 12 months
Quality of life measured with the SF-36
Quality of Life assessed using the Short Form-36 (SF-36) questionnaire. The SF-36 is a validated multipurpose, short form health survey which contains 36 questions representing eight different health domains. These domains are combined into a mental and physical component scale. From each domain, scores ranging from 0 to 100 points are derived, with lower scores indicating poorer quality of life.
Time frame: 6 weeks and 3, 6 and 12 months
Pain measured with the Visual Analogue Scale (VAS)
Pain as indicated on a visual Analogue Scale (VAS), in which 0 implies no pain and 10 the worst possible pain. Patients will be asked to give an estimation of the type and quantity of pain medication taken during all follow-up visits.
Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months
Range of motion measured with a goniometer
Range of motion of the wrist measured on both sides with a handheld goniometer in degrees. ROM includes pronation and supination, ulnar and radial deviation and palmar and dorsal flexion of the wrist.
Time frame: 6 weeks and 3, 6 and 12 months
Grip strength measured with a dynamometer
Grip strength as measured with a dynamometer in kg as the mean of three measurements. Grip strength will be measured as a percentage of the uninjured side.
Time frame: 6 weeks and 3, 6 and 12 months
Number of patients with loss of reduction
Radiographs will be performed to ensure that loss of reduction has not occurred. Loss of reduction is defined as \<15° radial inclination, \>15° of dorsal angulation or \>20° of volar angulation, \>3 mm shortening of ulnar variance or \>2 mm of articular step-off or gap. Radial inclination, volar/dorsal tilt, ulnar variance and radial length will be measured digitally in the Picture Archiving and Communication System (PACS) on standard posterior anterior (PA), lateral carporadial and lateral X-rays of the wrist. If loss of reduction occured, operative treatment will be considered, but will be at discretion of the treating surgeon.
Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months
Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire
Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire.
Time frame: 6 weeks and 3, 6 and 12 months
Number of complications in both treatment groups
Number of complications in both patients treated with plasterimmobilisation and ORIF. Complications include loss of reduction, cross-overs from conservative to operative treatment, fracture malunion or non-union, wound and/or plate infection, tendon irritation and/or rupture, neuropathy and the occurrence of complex regional pain syndrome.
Time frame: 1, 3 and 6 weeks and 3, 6 and 12 months
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