Methods/Design
Study Design
This study will be conducted as a prospective randomized clinical trial (see Figures 1 and 2) in which three weeks of plaster cast immobilization is compared with five weeks of plaster cast immobilization. Patients will be treated in a short arm plaster cast. Patients will only receive physiotherapy if necessary. The study started, September 1, 2012.
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Figure 1.
Randomization and inclusion period.
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Figure 2.
Follow-up.
Recruitment and Consent
Patients with distal radius fractures will be initially managed on the emergency department. Using the criteria for displacement: distal radial fractures with initial dorsal angulation up to 15° and axial radial shortening of not more than 5 mm. Patients will be included if closed reduction of the distal radius fracture is not necessary according to these criteria for misalignment.
They will receive written information and a consent form from the attending physician, the clinical investigator or a research assistant. After providing informed consent, eligible patients will be randomized within one week. An independent research assistant will perform concealed permuted block randomization using a computer-generated randomization schedule after stratification for fracture type, gender and age. Allocation will be at random to four blocks.
Blinding
Functional Status. An independent research assistant will perform a blinded evaluation of the trial patients' functional status.
Radiographic Outcome. Radiographic evaluation of the alignment of the distal radius will be performed blinded for the intervention group. In addition to the treating physician, two independent experts will assess the Lidström score for the repeated X-rays of the wrist blinded from the first assessment (Figure 3).
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Figure 3.
Anatomical radiological classification for distal radial fractures according to Lidström.
Bias Prevention
To prevent bias stratification by age (younger and older than 60 years) and gender will be performed (Table 1).
Study Population
The study population is defined as all adult patients with a non-displaced distal radius fracture. All patients should be independent in activities of daily living. Evaluation of eligible patients will take place either at the emergency department or at the outpatient department of the Spaarne Hospital, Hoofddorp. Patients are eligible using the following in- and exclusion criteria:
Inclusion Criteria
Age > 18 years.
Unilateral fracture of distal radius without misalignment (dorsal angulation <15°, Axial radial shortening <5 mm.
Independent for activities of daily living.
Exclusion Criteria
Fracture of contralateral arm.
Other fractures at the ipsilateral arm (excluded carpal fractures).
Pre-existent abnormalities fractured distal radius.
Open fractures.
Fracture that needs reduction.
Outcome Measures
The primary outcome measure is the Quick-DASH (Disabilities of the Arm, Shoulder and Hand) score, which reflects both function and pain and PRWE (Patient Related Wrist Evaluation).
The DASH Outcome Measure is a validated 30-item, self-reported questionnaire designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time.
The Quick-DASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the Quick-DASH uses 11 items (scored 1–5) to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The right and left elbow will be assessed separately. At least 10 of the 11 items must be completed for a score to be calculated. The scores will be transformed to a 0–100 scale for easy comparison. A higher score indicates greater disability.
Like the DASH, the Quick-DASH contains 2 optional modules to measure symptoms and function in athletes, performing artists and other workers whose jobs require a high degree of physical performance. These optional models are scored separately; each contains four items, scored 1–5. All items must be completed for a score to be calculated.
PRWE score is the most responsive instrument for evaluating the outcome in patients with distal radius fractures.
The secondary outcome measures are:
Range of motion.
Pain (assessed by the VAS scale).
Complications: dislocation, complex regional pain syndrome and mal/nonunion.
Pain level will be determined using a 10-point Visual Analog Scale (VAS), in which zero implies no pain and ten implies the worst possible pain.
ROM will be measured on both sides using a goniometer.
In addition to the outcome variables mentioned above, the following data will be collected:
Intrinsic variables (baseline data): age, gender, American Society of Anesthesiologists' ASA classification, tobacco consumption, alcohol consumption, comorbidity, social status/household composition, dominant side, and medication use.
Injury related variables: affected side, mechanism of injury.
Intervention-related variables: time between injury and start of physical therapy and number of physical therapy sessions.
Study Procedures
After inclusion, all patients will be followed for one year in total. Clinical assessments will occur at the time of admission (ED), one week (3–10-day window), three weeks (11–28-day window) or five weeks (4–8-week window), six weeks (4–8-week window), three months (11–15-week window), six months (5–7-month window), and 12 months (12–14-month window) after start of treatment.
At each FU visit, the research coordinator or research assistant will ascertain patient status (i.e., secondary interventions, adverse events/complications, deaths) and will verify information within medical records.
At each FU visit, the patients will be asked to indicate the pain level on a VAS.
At each visit from six weeks onwards, the ROM of the wrist will be measured using a goniometer by a doctor blinded for the treatment method. In addition, patients will be asked to complete the questionnaires relating to disability (Quick-DASH score including optional modules, PRWE Score), and healthcare consumption.
Plain X-rays of the wrist will be made at the time of presentation in the hospital (ED), and at the follow-up visit after 6 weeks three months, six months and one year. The X-ray at 12 months will be taken in order to determine the grade of degenerative joint changes.
Time to define the presence of a malunion will be at three months. Intention-to-treat principle will be maintained (see Figure 2).
X-ray: control X-ray according to standard guidelines, assessment using Lidström score.
Function: functional assessment using functional outcome scores, range of motion, pain assessment using VAS scale.
ED = Emergency Department, D = days, W = weeks, M = months.
Sample Size
The primary outcome will be the QuickDASH score of which the minimal clinically important difference is 14 points. Based on a difference of 14 points, the sample size of 30 patients per treatment group was calculated with a power (1-β) of 80 percent and a type I error (α) of 5 percent, allowing for 10 percent drop-out. In total 70 patients will be included.
Withdrawal of Individual Subjects
Subjects can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a subject from the study for urgent medical reasons.
Statistical Analysis
Descriptive Statistics. Data from the demographic data collection and the outcome parameters will be cleaned blindly from the treatment data. Data are presented as mean scores with 95% confidence intervals.
Univariate Analysis. The analysis of this study will be carried out according to the intention-to-treat principle, i.e. the patients will remain in the group they will be randomly allocated to at baseline. Analysis of functional outcome will be assessed using repeated-measures analysis of variance (GLM 4) with the time as the within-group factor and the treatment as the between-group factor. Post-hoc analysis will be performed on the time of randomization. Group comparisons at the different time points will be made only when the overall repeated-measures tests are statistically significant. All scores will be tested for normality using the Kolmogorov-Smirnov test. Parametric variables will be compared using the Student's t-test, while non-parametric and ordinal variables will be compared using the Mann–Whitney U statistic. Nominal variables will be compared across independent groups using the chi-squared test or Fisher's exact test. Homogeneity of variance will be assessed using Levene's test. Also a multiple regression will be performed. SPSS statistical software (version 11.0.1) will be used for the analysis, in which two-tailed P value < 0.05 will be considered significant.
Ethical Considerations
Regulation Statement. The study was approved by the Regional Ethical Committee and will be carried out in compliance with the Declaration of Helsinki on ethical principles for medical research involving human subjects. The Medical Ethics Committee Noord-Holland acts as central ethics committee for this trial (reference number M011-059; NL38449.09.11).
Recruitment and Consent
Patients with a distal radial fracture will be treated by the physician on call in the Emergency Department. The only difference is that duration of immobilization will be decided after randomization. Randomization will occur after informed consent.
Administrative Aspects and Publication
Handling and Storage of Data and Documents. The data will be coded by patient number. Research data will be stored in a database (PASW statistics 18 and Microsoft Excel), and will be handled confidentially and anonymously. Research data that can be traced to individual persons can only be viewed by authorized personnel. These persons are the members of the research team, members of the health care inspection, and members of the Medical Ethics Committee of the Academic Medical Center Amsterdam. Review of the data may be necessary to ensure the reliability and quality of the research. The handling of personal data is in compliance with the Dutch Data Protection Act (in Dutch: 'Wet Bescherming Persoonsgegevens', WBP) and the privacy regulation of the Academic Medical Center Amsterdam.