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Cochrane Database of Systematic Reviews Protocol - Intervention

External fixation versus conservative treatment for distal radial fractures in adults

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

We aim to evaluate the evidence from randomised controlled trials for the use of external fixation for fractures of the distal radius in skeletally mature people.

We will compare the relative effects (benefits and harms) of any method of external fixation versus conservative treatment involving plaster or brace use in adults with these injuries. Augmented external fixation where supplementary percutaneous (through the skin) pinning is used to fix or support distal radial fragments will also be considered.

We will consider these effects primarily in terms of patient‐assessed functional outcome and satisfaction, and other measures of function and impairment, pain and discomfort, the incidence of complications, anatomical deformity and use of resources.

We plan to study the outcomes in different age groups and for different types of fractures, especially whether they are extra‐articular or intra‐articular.

Background

Reader's note: This protocol is one of five reviews that will cover all surgical interventions for treating distal radial fractures in adults. Each review will provide updated evidence (from February 2003) for one of the several surgical categories that are presented together in the currently available review (Handoll 2003a). Following publication of the five reviews, Handoll 2003a will be converted to an 'umbrella' review summarising the evidence for surgical treatment for these fractures.

Description of the condition: distal radial fracture in adults
Fractures of the distal radius, often referred to as "wrist fractures", are common in both children and adults. They are usually defined as occurring within three centimetres of the radiocarpal joint of the radius, where the lower end of the radius interfaces with two (the lunate and the scaphoid) of the eight bones forming the carpus (the wrist). The majority are closed injuries, the overlying skin remaining intact.

In this review, we consider the treatment of distal radial fracture in adults only, in whom they are one of the most common fractures, predominantly in white and older populations in the developed world (Sahlin 1990; Singer 1998; Van Staa 2001). In women, the incidence of these fractures increases with age, starting at around 40 years of age. Before this age, the incidence is higher in men (Singer 1998). In contrast, between 60 to 94 years of age, females predominate. A recent multi‐centre study in the United Kingdom of patients aged 35 years and above with Colles' fracture (see below) reported an annual incidence of 9/10,000 in men and 37/10,000 in women (O'Neill 2001).

Young adults usually sustain this injury as a result of high‐energy trauma, such as a traffic accident. In older adults, especially females, the fracture more often results from low‐energy or moderate trauma, such as falling from standing height. This reflects the greater fragility of the bone, resulting from disuse or post menopausal osteoporosis. It has been estimated that, at 50 years of age, a white woman in USA or Northern Europe has a 15% lifetime risk of a distal radius fracture whereas a man has a lifetime risk of just over two per cent (Cummings 1985). More recent estimates (Van Staa 2001) of lifetime risk of radius or ulna fracture at 50 years of age are similar: 16.6% for women versus 2.9% for men.

Distal radial fractures are usually treated on an outpatient basis with estimates of around 20% of patients (mainly older people) requiring hospital admission (Cummings 1985; O'Neill 2001). This figure will include all people receiving surgery.

Classification
Surgeons have attempted to classify fractures by anatomical configuration or fracture pattern, to help in their management. Simple classifications were based on clinical appearance and often named after those who described them. In the distal radius, the term "Colles' fracture" is still used for a fracture in which there is an obvious and typical clinical deformity (commonly referred to as a dinner fork deformity) ‐ dorsal displacement, dorsal angulation, dorsal comminution, and radial shortening. The introduction of X‐rays and other imaging methods made it clear that the characteristic deformity may be associated with a range of different fracture patterns, which may be important determinants of outcome, and therefore the way in which treatment is conducted. For example, the fracture through the distal radius in a Colles' fracture may be extra‐articular (leaving the articular surface of the radius intact) or intra‐articular (the articular surface is disrupted, sometimes in a complex manner). Numerous classifications have been devised to define and group different fracture patterns (Chitnavis 1999). One of the most commonly used is that of Frykman which distinguishes between extra‐articular fractures and intra‐articular fractures of the radiocarpal and radio‐ulnar joints, and the presence or absence of an associated distal ulnar fracture (Frykman 1967). Another commonly used system is the AO (Arbeitsgemeinschaft fur Osteosynthesefragen) system (Muller 1991) which divides the fractures into three major groups: group A (extra‐articular), group B (simple/partial intra‐articular), and group C (complex/complete intra‐articular). These three groups are then subdivided, yielding 27 different fracture types. Other classification systems have attempted to link fracture type more directly with fracture management. For instance, Cooney 1993 proposed a 'Universal Classification' based on fracture displacement, articular involvement, reducibility (whether the fracture can be reduced; that is whether the bone fragments can be put back in place) and stability (whether, once reduced, the fragments will remain so).

Description of the intervention: external fixation
In the last century, most distal radial fractures in adults were treated conservatively, by reduction of the fracture when displaced, and stabilisation in a plaster cast or other external brace. Surgeons and other clinicians have recognised for many years that, particularly in older people with weakened bones from osteoporosis, the results of such conservative treatment are not consistently satisfactory (for an updated review of the evidence: see Handoll 2003b). This has resulted in attempts to develop other strategies involving surgery aimed at more accurate reduction and more reliable stabilisation of these fractures.

One such strategy is external fixation (Capo 2006; Fernandez 1999; Pennig 1996). Typically this is a closed, minimally invasive method where, in contrast to open surgery, the fractured bone is not exposed to direct view. Metal pins or screws are driven into bone, generally via small incisions of the skin and after drilling, on either side of the fracture. These pins are then held apart or fixed externally, such as by incorporation into a plaster cast or securing into the frame of an external fixator. The external component acts to stabilise or fix the reduced fracture. Fracture reduction or alignment of the bony fragments is generally achieved by closed means, often in the process of applying external fixation. Reduction may be assisted by the application of a percutaneously (through the skin) inserted wire used as a 'joy stick' to move the bony fragments back into place. There is considerable variety in the techniques (such as for pin insertion and placement) and devices used for external fixation. Some devices are 'non‐bridging' (of the wrist joint) in that the distal pins are placed in the distal radial fragment. In 'bridging fixators', the distal pins are placed in one or more metacarpal bones. Some fixators are linear or uniplanar, whereas others are multiplanar. In addition, some bridging fixators have an articulation (e.g. a ball joint) that allows limited wrist movement. The duration and extent of immobilisation with external fixation also vary. In some cases, external fixation may be augmented by additional methods of fracture fixation. In this review, we will include only trials using supplementary percutaneous pinning. This involves extra pins or wires being inserted through the skin and used to fix or support distal radial fragments.

Complications
Complications from this injury are diverse and frequent (Altissimi 1986; Atkins 1989; Cooney 1980). Some are associated with the injury itself. As well as concomitant injuries to soft tissues, fracture displacement can further compromise blood vessels, tendons and nerves, with median nerve dysfunction being the most common complication (Belsole 1993). Late complications include midcarpal instability and post‐traumatic arthritis which can occur several months or years after injury (Knirk 1986; Taleisnik 1984).

Complications can also result from treatment interventions and include residual finger stiffness, which may be due to faulty application of plaster casts (Gartland 1951), pin track infection, soft tissue injury including tendon rupture, and additional fractures from external fixation. Complex regional pain syndrome type 1, generally termed reflex sympathetic dystrophy (RSD), but also referred to as algodystrophy, Sudeck's atrophy and sometimes shoulder‐hand syndrome (Fernandez 1996) is a major complication requiring many months of physiotherapy to alleviate symptoms (pain and tenderness, impairment of joint mobility, swelling, dystrophy, vasomotor instability) in serious cases. The etiology of RSD is often unclear.

Why it is important to do this review
External fixation is one of the key methods for surgical fixation of distal radial fractures. A key question is whether it produces superior results to conservative treatment. The answer to this question is likely to depend particularly on fracture configuration and bone quality. The issue of what is the best method of external fixation will be addressed in a separate review.

Objectives

We aim to evaluate the evidence from randomised controlled trials for the use of external fixation for fractures of the distal radius in skeletally mature people.

We will compare the relative effects (benefits and harms) of any method of external fixation versus conservative treatment involving plaster or brace use in adults with these injuries. Augmented external fixation where supplementary percutaneous (through the skin) pinning is used to fix or support distal radial fragments will also be considered.

We will consider these effects primarily in terms of patient‐assessed functional outcome and satisfaction, and other measures of function and impairment, pain and discomfort, the incidence of complications, anatomical deformity and use of resources.

We plan to study the outcomes in different age groups and for different types of fractures, especially whether they are extra‐articular or intra‐articular.

Methods

Criteria for considering studies for this review

Types of studies

Any randomised or quasi‐randomised (method of allocating participants to a treatment which is not strictly random e.g. by date of birth, hospital record number, alternation) controlled clinical trials comparing external fixation with conservative methods for treating distal radial fractures in adults will be considered.

Types of participants

Patients of either sex who have completed skeletal growth, with a fracture of the distal radius. External fixation may be considered as primary treatment or take place after the failure of initial conservative management, generally within two to three weeks. Augmented external fixation in the form of supplementary percutaneous pinning will also be included. Trials with a mixed population of adults and children will be included provided the proportion of children was clearly small (< 5%); otherwise they will be excluded unless separate data for adults are obtained. We consider it unlikely that we will find trials comparing external fixation with conservative treatment for fracture patterns such as the Barton's fractures (Smith 1988) that are inherently unstable and generally considered not to be amenable to conservative or external fixation. Nonetheless, if found, trials with these types of fractures will be considered for inclusion, and separate subgroup data sought for mixed fracture populations.

Types of interventions

Randomised comparisons of surgical interventions involving external fixation by itself or with supplementary percutaneous pinning versus conservative interventions such as plaster cast immobilisation.

We will exclude trials comparing different methods, including techniques and devices, of external fixation; or trials comparing external fixation with other methods of surgical fixation, such as percutaneous pinning, or trials evaluating the use of supplementary methods, such as bone grafts and substitutes, other than percutaneous pinning, to external fixation compared with conservative treatment. These comparisons will be covered in other reviews, including one covering the use of bone grafts and substitutes.

Types of outcome measures

Our primary outcome of choice would be the number of people with an uncomplicated and speedy restoration of a pain‐free fully‐functioning wrist and arm with acceptable anatomic restoration and appearance. However, compatible with the general assessment and presentation of outcome within the orthopaedic literature, we shall report outcome in the following four categories.

Primary outcomes

(1) Functional outcome and impairment

  • Patient functional assessment instruments such as Short Form‐36 (SF‐36), the Disability of the Arm, Shoulder, and Hand questionnaire (DASH) and the Patient‐Rated Wrist Evaluation (PRWE) (MacDermid 2000)

  • Return to previous occupation, including work, and activities of daily living

  • Grip strength

  • Pain

  • Range of movement (wrist and forearm mobility): range of movement for the wrist is described in terms of six parameters: flexion (ability to bend the wrist downwards) and extension (or upwards); radial deviation (ability to bend the wrist sideways on the thumb side) and ulnar deviation (on the little finger side); and pronation (ability to turn the hand so that the palm faces downwards) and supination (palm faces upwards)

(2) Clinical outcome

  • Residual soft tissue swelling

  • Early and late complications associated with distal radial fractures or their treatment, including reflex sympathetic dystrophy (RSD) and post traumatic osteoarthritis

  • Cosmetic appearance

  • Patient satisfaction with treatment

Secondary outcomes

(3) Anatomical outcome (anatomical restoration and residual deformity)

  • Radiological parameters include radial length or shortening and shift, dorsal angulation, radial inclination or angle, ulnar variance, and for intra‐articular fractures: step off and gap deformity of the articular surface (Fernandez 1996; Kreder 1996). Composite measures include malunion and total radiological deformity. Definitions of four of the most commonly reported radiological parameters are presented in Table 1.

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Table 1. Definitions of some radiological parameters

Parameter

Definition

Normal value

Dorsal angulation (dorsal or volar or palmar tilt)

Angle between a) the line which connects the most distal points of the dorsal and volar cortical rims of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Side view of wrist.

Palmar or volar tilt: approximately 11‐12 degrees.

Radial length

Distance between a) a line drawn at the tip of the radial styloid process, perpendicular to the longitudinal axis of the radius and b) a second perpendicular line at the level of the distal articular surface of the ulnar head. Frontal view.

Approximately 11‐12 mm.

Radial angle or radial inclination

Angle between a) the line drawn from the tip of the radial styloid process to the ulnar corner of the articular surface of the distal end of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Frontal view.

Approximately 22‐23 degrees.

Ulnar variance

Vertical distance between a) a line drawn parallel to the proximal surface of the lunate facet of the distal radius and b) a line parallel to the articular surface of the ulnar head.

Usually negative variance (e.g. ‐1 mm) or neutral variance.

(4) Resource use

  • Hospital stay, number of outpatient attendances and other costs.

Timing of outcome assessment
Results will usually be collected for the final follow‐up time for which these are available. However, we will also note interim results where a marked and important difference in the timing of recovery has occurred.

Search methods for identification of studies

Electronic database searches
We will search the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (in The Cochrane Library), MEDLINE, EMBASE, CINAHL and reference lists of articles. We will also search Current Controlled Trials at www.controlled‐trials.com and the UK National Research Register at www.update‐software.com/national/ for ongoing and recently completed trials. No language restrictions will be applied.

The following search strategies will be used:

The Cochrane Library (Wiley InterScience)
#1 MeSH descriptor Radius Fractures explode all trees in MeSH products
#2 MeSH descriptor Wrist Injuries explode all trees in MeSH products
#3 (#1 OR #2)
#4 ((distal near radius) or (distal near radial)) in Title, Abstract or Keywords in all products
#5 (colles or smith or smiths) in Title, Abstract or Keywords in all products
#6 wrist* in Title, Abstract or Keywords in all products
#7 (#4 OR #5 OR #6)
#8 fractur* in Title, Abstract or Keywords in all products
#9 (#7 AND #8)
#10 (#3 OR #9)

In MEDLINE (OVID‐WEB) the following search strategy will be combined with all three sections of the optimal MEDLINE search strategy for randomised trials (Higgins 2005).
1. exp Radius Fractures/
2. Wrist Injuries/
3. (((distal adj3 (radius or radial)) or wrist or colles or smith$2) adj3 fracture$).ti,ab.
4. or/1‐3

Similar search strategies will be used for EMBASE (OVID‐WEB) and CINAHL (OVID‐WEB): see Table 2.

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Table 2. Search strategies for CINAHL and EMBASE (OVID‐WEB)

CINAHL

EMBASE

1. Radius Fractures/
2. Wrist Injuries/
3. or/1‐2
4. (((distal adj3 (radius or radial)) or wrist or colles or smith$2) adj3 fracture$).ti,ab.
5. or/3‐4
6. exp Clinical Trials/
7. exp Evaluation Research/
8. exp Comparative Studies/
9. exp Crossover Design/
10. clinical trial.pt.
11. or/6‐10
12. ((clinical or controlled or comparative or placebo or prospective or randomi#ed) adj3 (trial or study)).tw.
13. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw.
14. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw.
15. (cross?over$ or (cross adj1 over$)).tw.
16. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw.
17. or/12‐16
18. or/11,17
19. and/5,18

1. (((distal adj3 (radius or radial)) or wrist or colles$2 or smith$2) adj3 fracture$).tw.
2. Colles Fracture/ or Radius Fracture/ or Wrist Fracture/ or Wrist Injury/
3. or/1‐2
4. exp Randomized Controlled trial/
5. exp Double Blind Procedure/
6. exp Single Blind Procedure/
7. exp Crossover Procedure/
8. or/4‐8
9. ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw.
10. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw.
11. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw.
12. (cross?over$ or (cross adj1 over$)).tw.
13. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw.
14. or/9‐13
15. or/8,14
16. Animal/ not Human/
17. 15 not 16
18. and/3,17

Other sources
We will include the findings from handsearches of the British Volume of the Journal of Bone and Joint Surgery supplements (1996 onwards) and abstracts of the American Society for Surgery of the Hand annual meetings (2000 onwards: www.assh.org/), the American Orthopaedic Trauma Association annual meetings (1996 onwards: www.ota.org/education/archives.html) and American Academy of Orthopaedic Surgeons annual meeting (2004 onwards: www.aaos.org/wordhtml/libscip.htm). We will also include handsearch results from the final programmes of SICOT (1996 & 1999) and SICOT/SIROT (2003), and the British Orthopaedic Association Congress (2000, 2001, 2002 and 2003), and various issues of Orthopaedic Transactions and supplements of Acta Orthopaedica Scandinavica.

We will also scrutinise weekly downloads of "Fracture" articles in new issues of 17 journals (Acta Orthop Scand; Am J Orthop; Arch Orthop Trauma Surg; Clin J Sport Med; Clin Orthop; Emerg Med Clin North Am; Foot Ankle Int; Injury; J Accid Emerg Med; J Am Acad Orthop Surg; J Arthroplasty; J Bone Joint Surg Am; J Bone Joint Surg Br; J Foot Ankle Surg; J Orthop Trauma; J Trauma; Orthopedics) from AMEDEO (www.amedeo.com).

Data collection and analysis

Selection of studies
All review authors will independently assess potentially eligible trials identified via the search for inclusion using a pre‐piloted form. Any disagreement will be resolved by discussion.

Data extraction and management
Two of the review authors (HH and JH) will extract trial details and data using a data extraction form and enter these into RevMan. Any unresolved disagreement will be resolved by discussion with the third author (RM). Extraction of results from graphs in trial reports will be considered where data are not provided in the text or tables. We will contact trialists of trials not reported in full journal publications for additional information or data. Contact with other trial authors will be dictated by the vintage of the publication, a general impression of the expected gain, and anticipated or known difficulty in locating trial authors.

Results will be collected for the final follow‐up time for which these are available. We will, however, note instances where a marked and important difference in recovery in functional outcomes between the two or more groups under comparison has occurred that has subsequently been lost.

Assessment of methodological quality
Two of the review authors (HH and JH) will independently assess methodological quality of the included trials using a pre‐piloted form. Any unresolved disagreement will be resolved by discussion with the third author (RM). Titles of journals, names of authors or supporting institutions will not be masked at any stage. A modification of the quality assessment tool used in the current 'umbrella' review will be used. Instead of scores, the each item will be graded either 'Y', '?' or 'N', respectively indicating that the quality criteria were met for the item ("Yes"), or possibly or only partially met for the item ("Possible, partial"), or not met ("No"). The rating scheme covering 11 aspects of trial validity plus brief notes of coding guidelines for selected items are given in Table 3.

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Table 3. Methodological quality assessment scheme

Items

Scores

Notes

(1) Was the assigned treatment adequately concealed prior to allocation?

Y = method did not allow disclosure of assignment.
? = small but possible chance of disclosure of assignment or unclear.
N = quasi‐randomised, or open list or tables.

Cochrane code (see Handbook): Clearly yes = A; Not sure = B; Clearly no = C.

(2) Were the outcomes of participants who withdrew described and included in the analysis (intention‐to‐treat)?

Y = withdrawals well described and accounted for in analysis.
? = withdrawals described and analysis not possible, or probably no withdrawals.
N = no mention, inadequate mention, or obvious differences and no adjustment.

(3) Were the outcome assessors blinded to treatment status?

Y = effective action taken to blind assessors.
? = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted.
N = not mentioned or not possible.

(4) Were important baseline characteristics reported and comparable?

Y = good comparability of groups, or confounding adjusted for in analysis.
? = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data.
N = large potential for confounding, or not discussed.

Although many characteristics including hand dominance are important, the principal confounders are considered to be age, gender, type of fracture.

(5) Were the trial participants blind to assignment status after allocation?

Y = effective action taken to blind participants.
? = small or moderate chance of unblinding of participants.
N = not possible, or not mentioned (unless double‐blind), or possible but not done.

(6) Were the treatment providers blind to assignment status?

Y = effective action taken to blind treatment providers.
? = small or moderate chance of unblinding of treatment providers.
N = not possible, or not mentioned (unless double‐blind), or possible but not done.

(7) Were care programmes, other than the trial options, identical?

Y = care programmes clearly identical.
? = clear but trivial differences, or some evidence of comparability.
N = not mentioned or clear and important differences in care programmes.

Examples of clinically important differences in other interventions are: time of intervention, duration of intervention, anaesthetic used within broad categories, operator experience, difference in rehabilitation.

(8) Were the inclusion and exclusion criteria for entry clearly defined?

Y = clearly defined (including type of fracture).
? = inadequately defined.
N = not defined.

(9) Were the outcome measures used clearly defined?

Y = clearly defined.
? = inadequately defined.
N = not defined.

(10) Were the accuracy and precision, with consideration of observer variation, of the outcome measures adequate; and were these clinically useful and did they include active follow up?

Y = optimal.
? = adequate.
N = not defined, not adequate.

(11) Was the timing (e.g. duration of surveillance) clinically appropriate?

Y = optimal. (> 1 year)
? = adequate. (6 months ‐ 1 year)
N = not defined, not adequate. (< 6 months)

Measures of treatment effect
Where available, quantitative data, both dichotomous and continuous, that are reported in individual trial reports for outcomes listed in the inclusion criteria will be presented in the analyses. Relative risks and 95% confidence intervals will be calculated for dichotomous outcomes and mean differences and 95% confidence intervals calculated for continuous outcomes.

Unit of analysis issues
The unit of randomisation in these trials is usually the individual patient. Exceptionally, randomisation may be by fractures as in the case of people with bilateral fractures or data for trials may be presented for fractures or limbs rather than individual patients, the unit of analysis. For the second case, where unavoidable, we will present the number of fractures rather than patients. However, we will perform sensitivity analyses, making various assumptions, where a result is statistically significant.

Dealing with missing data
Where appropriate, we will perform intention‐to‐treat analyses to include all people randomised to the intervention groups. We will investigate the effect of drop outs and exclusions by conducting worse and best scenario analyses. We will be alert to the potential mislabelling or non identification of standard errors for standard deviations. Unless missing standard deviations can be derived from confidence interval data, we will not assume values in order to present these in the analyses.

Assessment of heterogeneity
Heterogeneity will be assessed by visual inspection of the forest plot (analysis) along with consideration of the test for heterogeneity and the I² statistic (Higgins 2003).

Assessment of reporting biases
In the unlikely event that sufficient data are available, we would attempt to assess publication bias by preparing a funnel plot. Our search of 'grey literature' and pursuit of trials listed in clinical trial registers should help to avoid publication bias.

Data synthesis (meta‐analysis)
If considered appropriate, results of comparable groups of trials will be pooled. Initially we will use the fixed‐effect model and 95% confidence intervals. We will also consider using the random‐effects model, especially where there is unexplained heterogeneity.

Subgroup analysis and investigation of heterogeneity
We plan subgroup analyses by age and gender and type of fracture (primarily extra‐articular versus intra‐articular fractures). Presentation in separate subgroups will be considered where there is a fundamental difference in the method of external fixation (such as bridging versus non‐bridging external fixation). To test whether the subgroups are statistically significantly different from one another, we will test the interaction using the technique outlined by Altman and Bland (Altman 2003).

Sensitivity analysis
Where possible, we plan sensitivity analyses examining various aspects of trial and review methodology, including the effects of missing data, study quality (specifically allocation concealment, outcome assessor blinding and reportage of surgical experience), and inclusion of trials only reported in abstracts. Again to test whether the subgroups are statistically significantly different from one another, we will test the interaction using the technique outlined by Altman and Bland (Altman 2003).

Interpretation of the evidence
We will grade the findings of the treatment comparisons according to the six categories of effectiveness used by contributors to Issue 14 of Clinical Evidence (BMJ 2006) (see Table 4) to assist our interpretation of the evidence.

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Table 4. Categories of effectiveness (definitions)

Rank

Category

Definition

1

Beneficial

Interventions for which effectiveness has been demonstrated by clear evidence from randomised controlled trials, and for which expectation of harms is small compared with the benefits.

2

Likely to be beneficial

Interventions for which effectiveness is less well established than for those listed under "beneficial".

3

Trade off between benefits and harms

Interventions for which clinicians and patients should weigh up the beneficial and harmful effects according to individual circumstances and priorities.

4

Unknown effectiveness

Interventions for which there is currently insufficient data or data of inadequate quality.

5

Unlikely to be beneficial

Interventions for which lack of effectiveness is less well established than for those listed under "likely to be ineffective or harmful"

6

Likely to be ineffective or harmful

Interventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence.

Table 1. Definitions of some radiological parameters

Parameter

Definition

Normal value

Dorsal angulation (dorsal or volar or palmar tilt)

Angle between a) the line which connects the most distal points of the dorsal and volar cortical rims of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Side view of wrist.

Palmar or volar tilt: approximately 11‐12 degrees.

Radial length

Distance between a) a line drawn at the tip of the radial styloid process, perpendicular to the longitudinal axis of the radius and b) a second perpendicular line at the level of the distal articular surface of the ulnar head. Frontal view.

Approximately 11‐12 mm.

Radial angle or radial inclination

Angle between a) the line drawn from the tip of the radial styloid process to the ulnar corner of the articular surface of the distal end of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Frontal view.

Approximately 22‐23 degrees.

Ulnar variance

Vertical distance between a) a line drawn parallel to the proximal surface of the lunate facet of the distal radius and b) a line parallel to the articular surface of the ulnar head.

Usually negative variance (e.g. ‐1 mm) or neutral variance.

Figures and Tables -
Table 1. Definitions of some radiological parameters
Table 2. Search strategies for CINAHL and EMBASE (OVID‐WEB)

CINAHL

EMBASE

1. Radius Fractures/
2. Wrist Injuries/
3. or/1‐2
4. (((distal adj3 (radius or radial)) or wrist or colles or smith$2) adj3 fracture$).ti,ab.
5. or/3‐4
6. exp Clinical Trials/
7. exp Evaluation Research/
8. exp Comparative Studies/
9. exp Crossover Design/
10. clinical trial.pt.
11. or/6‐10
12. ((clinical or controlled or comparative or placebo or prospective or randomi#ed) adj3 (trial or study)).tw.
13. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw.
14. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw.
15. (cross?over$ or (cross adj1 over$)).tw.
16. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw.
17. or/12‐16
18. or/11,17
19. and/5,18

1. (((distal adj3 (radius or radial)) or wrist or colles$2 or smith$2) adj3 fracture$).tw.
2. Colles Fracture/ or Radius Fracture/ or Wrist Fracture/ or Wrist Injury/
3. or/1‐2
4. exp Randomized Controlled trial/
5. exp Double Blind Procedure/
6. exp Single Blind Procedure/
7. exp Crossover Procedure/
8. or/4‐8
9. ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw.
10. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw.
11. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw.
12. (cross?over$ or (cross adj1 over$)).tw.
13. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw.
14. or/9‐13
15. or/8,14
16. Animal/ not Human/
17. 15 not 16
18. and/3,17

Figures and Tables -
Table 2. Search strategies for CINAHL and EMBASE (OVID‐WEB)
Table 3. Methodological quality assessment scheme

Items

Scores

Notes

(1) Was the assigned treatment adequately concealed prior to allocation?

Y = method did not allow disclosure of assignment.
? = small but possible chance of disclosure of assignment or unclear.
N = quasi‐randomised, or open list or tables.

Cochrane code (see Handbook): Clearly yes = A; Not sure = B; Clearly no = C.

(2) Were the outcomes of participants who withdrew described and included in the analysis (intention‐to‐treat)?

Y = withdrawals well described and accounted for in analysis.
? = withdrawals described and analysis not possible, or probably no withdrawals.
N = no mention, inadequate mention, or obvious differences and no adjustment.

(3) Were the outcome assessors blinded to treatment status?

Y = effective action taken to blind assessors.
? = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted.
N = not mentioned or not possible.

(4) Were important baseline characteristics reported and comparable?

Y = good comparability of groups, or confounding adjusted for in analysis.
? = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data.
N = large potential for confounding, or not discussed.

Although many characteristics including hand dominance are important, the principal confounders are considered to be age, gender, type of fracture.

(5) Were the trial participants blind to assignment status after allocation?

Y = effective action taken to blind participants.
? = small or moderate chance of unblinding of participants.
N = not possible, or not mentioned (unless double‐blind), or possible but not done.

(6) Were the treatment providers blind to assignment status?

Y = effective action taken to blind treatment providers.
? = small or moderate chance of unblinding of treatment providers.
N = not possible, or not mentioned (unless double‐blind), or possible but not done.

(7) Were care programmes, other than the trial options, identical?

Y = care programmes clearly identical.
? = clear but trivial differences, or some evidence of comparability.
N = not mentioned or clear and important differences in care programmes.

Examples of clinically important differences in other interventions are: time of intervention, duration of intervention, anaesthetic used within broad categories, operator experience, difference in rehabilitation.

(8) Were the inclusion and exclusion criteria for entry clearly defined?

Y = clearly defined (including type of fracture).
? = inadequately defined.
N = not defined.

(9) Were the outcome measures used clearly defined?

Y = clearly defined.
? = inadequately defined.
N = not defined.

(10) Were the accuracy and precision, with consideration of observer variation, of the outcome measures adequate; and were these clinically useful and did they include active follow up?

Y = optimal.
? = adequate.
N = not defined, not adequate.

(11) Was the timing (e.g. duration of surveillance) clinically appropriate?

Y = optimal. (> 1 year)
? = adequate. (6 months ‐ 1 year)
N = not defined, not adequate. (< 6 months)

Figures and Tables -
Table 3. Methodological quality assessment scheme
Table 4. Categories of effectiveness (definitions)

Rank

Category

Definition

1

Beneficial

Interventions for which effectiveness has been demonstrated by clear evidence from randomised controlled trials, and for which expectation of harms is small compared with the benefits.

2

Likely to be beneficial

Interventions for which effectiveness is less well established than for those listed under "beneficial".

3

Trade off between benefits and harms

Interventions for which clinicians and patients should weigh up the beneficial and harmful effects according to individual circumstances and priorities.

4

Unknown effectiveness

Interventions for which there is currently insufficient data or data of inadequate quality.

5

Unlikely to be beneficial

Interventions for which lack of effectiveness is less well established than for those listed under "likely to be ineffective or harmful"

6

Likely to be ineffective or harmful

Interventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence.

Figures and Tables -
Table 4. Categories of effectiveness (definitions)