Introduction
Background
Purpose of the analyses
Methods/design
Design
Study population
Inclusion criteria
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Age 60 years or older
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Displaced distal radius fracture, classified according to the Association for the Study of Internal Fixation/Orthopaedic Trauma Association (AO/OTA) [22] 23A (extra-articular distal radius fracture) or 23C (complete articular distal radius fracture). Displacement parameters include more than 10° dorsal angulation, referenced off a line perpendicular to the shaft of the radius or more than 3 mm shortening or more than a 2-mm articular step prior to reduction
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Medically fit for surgery
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Independent living (including hostel accommodation)
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Low-energy injury (fall from less than 1 m)
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Available for follow-up for 12 months
Exclusion criteria
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Patient unable to provide consent (due to cognitive incapacity or lack of English proficiency)
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Volar angulation
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Diaphyseal extension
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Partial articular fractures (AO/OTA 23B)
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Associated fracture or dislocation in any other body part that will affect the use of the involved wrist (ulnar styloid fracture will be permitted, as these are usually associated with the fracture under investigation)
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Open injury
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Previous wrist fracture on the same side
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Medical condition precluding anaesthetic
Intervention group
Control group
Patient and public involvement
Randomisation and allocation
Data collection
Baseline measure | Randomised | ||
---|---|---|---|
Surgical (n=__) | Non-surgical (n=__) | ||
Age (years), mean (range) | |||
Gender n (%) | Female | ||
Male | |||
Fracture type n (%) | 23A | ||
23C | |||
Radiographic features, mean (SD) | Dorsal angulation (degrees) | ||
Radial tilt (degrees) | |||
Ulnar variance (mms) | |||
Articular step (mms) | |||
Co-morbidities, n (%) | Diabetes? (Y/N) | ||
Smoker? (Y/N) | |||
Glucocorticoid treatment? (Y/N) | |||
Osteoporosis treatment? (Y/N) |
Baseline measure | Randomised | |
---|---|---|
Surgical (n = __) | Non-surgical (n = __) | |
Age (years), mean (range) | ||
Gender n (%) | ||
Female | ||
Male | ||
Fracture type n (%) | ||
23A | ||
23C | ||
Radiographic features, mean (SD) | ||
• Dorsal angulation (degrees) | ||
• Radial tilt (degrees) | ||
• Ulnar variance (mm) | ||
• Articular step (mm) | ||
Co-morbidities, n (%) | ||
• Diabetes? (Y/N) | ||
• Smoker? (Y/N) | ||
• Glucocorticoid treatment? (Y/N) | ||
• Osteoporosis treatment? (Y/N) |
Baseline measure | Observational | ||
---|---|---|---|
Surgical (n=__) | Non-surgical (n=__) | ||
Age (years), mean (range) | |||
Gender n (%) | Female | ||
Male | |||
Fracture type n (%) | 23A | ||
23C | |||
Radiographic features, mean (SD) | Dorsal angulation (degrees) | ||
Radial tilt (degrees) | |||
Ulnar variance (mms) | |||
Articular step (mms) | |||
Co-morbidities, n (%) | Diabetes? (Y/N) | ||
Smoker? (Y/N) | |||
Glucocorticoid treatment? (Y/N) | |||
Osteoporosis treatment? (Y/N) |
Outcome variables
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PRWE gathered at 3 months and 2, 5 and 10 years
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Disability of Arm, Shoulder and Hand (DASH) questionnaire at 12 months. The DASH is a 30-item patient-reported measure of disability and symptoms of the upper limb. It is a continuous score on a scale from 0 to 100 with higher scores indicating poorer outcomes [29]
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The EuroQol five-dimension five-level questionnaire (EQ-5D-5L), measuring health-related utility-based quality of life at 3 and 12 months and 2, 5 and 10 years. The EQ-5D-5L is a five-dimension patient-reported measure of health-related quality of life (HRQoL) with a separate visual analogue scale (VAS). Distributions of responses to each dimension can be reported categorically; it also produces two continuous variables, a EQ-utility index (EQ-UI) score and a EQ-VAS score. The EQ-UI score is scored on a scale of 0, equating to a health state equivalent to death and 1 equating to full health; it can also take negative values. Given that there are no published Australian normative data on which to calculate EQ-UI scores, UK norms will be used instead. The EQ-VAS score ranges from 0 to 100 with 0 equating to the worst health state imaginable and 100 equating to the best health state imaginable [30]
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Wrist pain using the numerical rating scale (NRS) at 3 and 12 months and 2, 5 and 10 years. The NRS is a patient-reported 11-point pain scale ranging from 0 to 10 with 0 equating to no pain and 10 equating to the worst possible pain
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Patient-reported treatment success (at 12 months and 2, 5 and 10 years, 5-point Likert scale). The treatment success scale is a non-standard scale. See Additional file 1
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Patient-rated bother with appearance (at 12 month and 2, 5 and 10 years, 5-point Likert scale). The treatment success scale is a non-standard scale. See Additional file 1
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Complications (including deep infection, reoperation, neuropathy, tendon irritation requiring treatment, tendon rupture, fracture non-union at 6 months, implant failure, complex regional pain syndrome, death) at 3 months, 12 months, 2, 5 and 10 years
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Radiographic measures (ulnar variance, dorsal angulation, radial tilt, articular step) measured at presentation, post reduction, and between 6 weeks and 12 months)
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Therapy utilisation up to 3 months (Yes/No) and continuing at 3 months (Yes/No)
Adverse events
Study hypotheses
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Significantly lower rates of major complications (including deep infection, reoperation, neuropathy, tendon irritation requiring treatment, tendon rupture, fracture non-union, and implant failure, complex regional pain syndrome, death) at 3 and 12 months post treatment
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Superior (closer to normal) radiographic outcomes (ulnar variance and articular step (millimetres), dorsal angulation and radial tilt (degrees)) at post reduction and 6 weeks or more
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Superior PRWE scores at 3 months, 2, 5 and 10 years to a level of clinical importance
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Superior DASH scores at 12 months, to a level of clinical importance. A difference of greater than 11 points will be considered to be clinically important [33]
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Superior health-related quality of life (EQ-UI and EQ-VAS scores at 3 months and 12 months, 2, 5 and 10 years to a level of clinical importance. A difference of greater than 0.1 points in the EQ-UI score has previously been used as the minimal clinically important difference (MCID) in orthopaedic surgery [34] and musculoskeletal [35] contexts and will be considered to be clinically important. A difference of 10 on the EQ-VAS has been reported as the MCID and will be considered to be clinically important [36]
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Lower patient-reported pain (numerical rating scale NRS) at 3 months and 12 months, 2, 5 and 10 years to a level of clinical importance. A systematic review on the MCIDs of Visual Analogue Scales (VAS) used for assessment of acute pain reported that the median MCID was 17 mm on a 100-mm scale [37]. Given that the NRS uses whole integers between 0 and 10, a value of 2 points or greater will be considered to be clinically important
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Superior patient-reported treatment success at 12 months, 2, 5 and 10 years (measured on a 5-point Likert scale)
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Less patient-rated bother with appearance at 12 months, 2, 5 and 10 years (measured on a 5-point Likert scale)
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Lower therapy utilisation up to and at 3 months as measured by the prevalence of therapy utilisation at 3 months
Power and sample size
Statistical analysis
Analysis principles
Outcome | Randomised | |||
---|---|---|---|---|
Surgical (n=__) | Non-surgical (n=__) | MD (95%CI) or odds ratio (95%CI) | ||
PRWE, mean (SD) | ||||
ED-5D-5L, mean (SD) | EQ-UI | |||
EQ-VAS | ||||
Pain on NRS (0-10) | ||||
Patient-reported treatment success n(%) | Very successful | |||
Successful | ||||
Neutral | ||||
Unsuccessful | ||||
Very unsuccessful | ||||
Therapy utilisation up to 3 months (Yes/No) n(%) | ||||
Therapy utilisation at 3 months (Yes/No) n(%) | ||||
Radiographic measures, mean (SD) | Dorsal angulation (degrees) | |||
Radial tilt (degrees) | ||||
Ulnar variance (mms) | ||||
Articular step (mms) |
Outcome | Observational | |||
---|---|---|---|---|
Surgical (n=__) | Non-surgical (n=__) | MD (95%CI) or odds ratio (95%CI) | ||
PRWE, mean (SD) | ||||
ED-5D-5L, mean (SD) | EQ-UI | |||
EQ-VAS | ||||
Pain on NRS (0-10) | ||||
Patient-reported treatment success n(%) | Very successful | |||
Successful | ||||
Neutral | ||||
Unsuccessful | ||||
Very unsuccessful | ||||
Therapy utilisation up to 3 months (Yes/No) n(%) | ||||
Therapy utilisation at 3 months (Yes/No) n(%) | ||||
Radiographic measures, mean (SD) | Dorsal angulation (degrees) | |||
Radial tilt (degrees) | ||||
Ulnar variance (mms) | ||||
Articular step (mms) |
Data integrity
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Selection bias; randomisation occurs immediately after consent and immediately prior to treatment assignment using a central computer-based randomisation service by telephone, using stratification and minimisation to ensure balanced treatment allocation for site, age and gender
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Performance bias; treatment, other than the interventions under study is identical in both groups. Participating surgeons have equipoise regarding the two treatment alternatives and were instructed not to express a treatment preference to the participants recruited to the randomised study
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Detection bias; the primary outcome is collected from participants by blinded researchers, by telephone. The statistician and investigators will be blinded to the treatment group during the analysis
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Attrition bias; attempts are made to minimise missing data, such as obtaining multiple contact details at recruitment and using telephone follow up rather than mail. Interim analyses of data completeness and accuracy of data entry are conducted on two occasions in the data collection period
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Reporting bias; the de-identified participant-level dataset and statistical code will be made available for collaborative research projects. All pre-specified outcomes will be reported
Methods for handling missing data
Trial profile (CONSORT flow) and baseline characteristics
Primary analysis
Outcome | Randomised | |||
---|---|---|---|---|
Surgical (n=__) | Non-surgical (n=__) | Mean difference (95%CI) | ||
PRWE | ||||
DASH | ||||
ED-5D-5D, mean (SD) | EQ-UI | |||
EQ-VAS | ||||
Pain on NRS (0-10) | ||||
Patient-reported treatment success n(%) | Very successful | |||
Successful | ||||
Neutral | ||||
Unsuccessful | ||||
Very unsuccessful | ||||
Patient-reported bother with appearance n(%) | Not at all | |||
Bothered a little | ||||
Bothered moderately | ||||
Very bothered | ||||
Extremely bothered | ||||
Radiographic measures, mean (SD) | Dorsal angulation (degrees) | |||
Radial tilt (degrees) | ||||
Ulnar variance (mms) | ||||
Articular step (mms) |
Secondary analysis
Outcome | Observational | |||
---|---|---|---|---|
Surgical (n=__) | Non-surgical (n=__) | Mean difference (95%CI) | ||
PRWE | ||||
DASH | ||||
ED-5D-5D, mean (SD) | EQ-UI | |||
EQ-VAS | ||||
Pain on NRS (0-10) | ||||
Patient-reported treatment success n(%) | Very successful | |||
Successful | ||||
Neutral | ||||
Unsuccessful | ||||
Very unsuccessful | ||||
Patient-reported bother with appearance n(%) | Not at all | |||
Bothered a little | ||||
Bothered moderately | ||||
Very bothered | ||||
Extremely bothered | ||||
Radiographic measures, mean (SD) | Dorsal angulation (degrees) | |||
Radial tilt (degrees) | ||||
Ulnar variance (mms) | ||||
Articular step (mms) |
Complication; frequency (incidence) | Randomised group | ||
---|---|---|---|
Surgical (n = _) | Non-surgical (n = _) | Odds ratio (95% CI) | |
Deep infection | n (%) | n (%) | |
Reoperation | n (%) | n (%) | |
Neuropathy | n (%) | n (%) | |
Tendon irritation requiring treatment | n (%) | n (%) | |
Tendon rupture | n (%) | n (%) | |
Fracture non-union at 6 months | n (%) | n (%) | |
Implant failure | n (%) | n (%) | |
CRPS | n (%) | n (%) | |
Death | n (%) | n (%) | |
Any complications | n (%) | n (%) |
Complication; frequency (incidence) | Randomised group | ||
---|---|---|---|
Surgical (n = _) | Non-surgical (n = _) | Odds ratio (95% CI) | |
Deep infection | n (%) | n (%) | |
Reoperation | n (%) | n (%) | |
Neuropathy | n (%) | n (%) | |
Tendon irritation requiring treatment | n (%) | n (%) | |
Tendon rupture | n (%) | n (%) | |
Fracture non-union at 6 months | n (%) | n (%) | |
Implant failure | n (%) | n (%) | |
CRPS | n (%) | n (%) | |
Death | n (%) | n (%) | |
Any complications | n (%) | n (%) |
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Continuous variables measured at 3 months and 12 months include EQ-5D-5L (UI and VAS scores), pain on NRS (0–10) and radiographic measures (dorsal angulation, radial tilt, ulnar variance and articular step). These measurements will be analysed using analysis of variance (ANOVA) with repeated measures
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Categorical variables measured at 3 months and 12 months include patient-reported treatment success (Likert) and patient-reported bother with appearance (Likert). See Additional file 1 for question format. These variables will be analysed by contingency table to compare the frequency of treatment success categories between the two randomised groups. Results will be displayed as odds ratio with 95% CIs (see Table 4 for example)
Baseline measure | Randomised arm (n=__) | Observational arm (n=__) | |
---|---|---|---|
Age (years), mean (range) | |||
Gender n (%) | Female | ||
Male | |||
Fracture type n (%) | 23A | ||
23C | |||
Radiographic features, mean (SD) | Dorsal angulation (degrees) | ||
Radial tilt (degrees) | |||
Ulnar variance (mms) | |||
Articular step (mms) | |||
Co-morbidities, n (%) | Diabetes? (Y/N) | ||
Smoker? (Y/N) | |||
Glucocorticoid treatment? (Y/N) | |||
Osteoporosis treatment? (Y/N) |
Sensitivity analyses
Outcome | Completed cases in randomised group | |||
---|---|---|---|---|
Surgical (n=__) | Non-surgical (n=__) | Mean difference (95%CI) | ||
PRWE | ||||
DASH | ||||
ED-5D-5D, mean (SD) | EQ-UI | |||
EQ-VAS | ||||
Pain on NRS (0-10) | ||||
Patient-reported treatment success n(%) | Very successful | |||
Successful | ||||
Neutral | ||||
Unsuccessful | ||||
Very unsuccessful | ||||
Patient-reported bother with appearance n(%) | Not at all | |||
Bothered a little | ||||
Bothered moderately | ||||
Very bothered | ||||
Extremely bothered | ||||
Radiographic measures, mean (SD) | Dorsal angulation (degrees) | |||
Radial tilt (degrees) | ||||
Ulnar variance (mms) | ||||
Articular step (mms) |
Outcome | As-treated allocation of randomised group | |||
---|---|---|---|---|
Surgical (n=__) | Non-surgical (n=__) | Mean difference (95%CI) | ||
PRWE | ||||
DASH | ||||
ED-5D-5D, mean (SD) | EQ-UI | |||
EQ-VAS | ||||
Pain on NRS (0-10) | ||||
Patient-reported treatment success n(%) | Very successful | |||
Successful | ||||
Neutral | ||||
Unsuccessful | ||||
Very unsuccessful | ||||
Patient-reported bother with appearance n(%) | Not at all | |||
Bothered a little | ||||
Bothered moderately | ||||
Very bothered | ||||
Extremely bothered | ||||
Radiographic measures, mean (SD) | Dorsal angulation (degrees) | |||
Radial tilt (degrees) | ||||
Ulnar variance (mms) | ||||
Articular step (mms) |
Outcome | Per-protocol allocation of randomised group | |||
---|---|---|---|---|
Surgical (n=__) | Non-surgical (n=__) | Mean difference (95%CI) | ||
PRWE | ||||
DASH | ||||
ED-5D-5D, mean (SD) | EQ-UI | |||
EQ-VAS | ||||
Pain on NRS (0-10) | ||||
Patient-reported treatment success n(%) | Very successful | |||
Successful | ||||
Neutral | ||||
Unsuccessful | ||||
Very unsuccessful | ||||
Patient-reported bother with appearance n(%) | Not at all | |||
Bothered a little | ||||
Bothered moderately | ||||
Very bothered | ||||
Extremely bothered | ||||
Radiographic measures, mean (SD) | Dorsal angulation (degrees) | |||
Radial tilt (degrees) | ||||
Ulnar variance (mms) | ||||
Articular step (mms) |