Scolaris Content Display Scolaris Content Display

Cochrane Database of Systematic Reviews Protocol - Intervention

Bone grafts and bone substitutes for treating distal radial fractures in adults

This is not the most recent version

Collapse all Expand all

Abstract

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

To evaluate the effectiveness of implanting bone scaffolding materials (bone grafts or bone substitutes) into bony defects resulting from fracture of the distal radius in skeletally mature people.

More specifically, we will compare the effectiveness of:

  • implanting bone scaffolding versus conservative treatment or surgical fixation (percutaneous pinning or external fixation or combinations of these);

  • implanting bone scaffolding used in conjunction with any method of surgical fixation versus the same method of surgical fixation alone;

  • different methods of bone scaffolding;

  • different types and durations of immobilisation after bone scaffolding.

We will consider outcome 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.

If data allow it, 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

Note: This is one of five reviews that will cover all surgical interventions for treating distal radial fractures in adults. Each review will provide updated evidence 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 in the distal radius within three centimetres of the radiocarpal joint, 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.

Distal radial fracture are one of the most common fractures in adults, occurring predominantly in white and older populations in the developed world (Sahlin 1990; Singer 1998; Van Staa 2001). In women, the incidence increases with age from around 40 years. Before this age, the incidence is higher in men (Singer 1998). A 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 osteoporosis. It has been estimated that, at 50 years of age, a white woman in the 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. It is estimated that around 20% of patients (mainly older people) require hospital admission (Cummings 1985; O'Neill 2001). This figure includes all people receiving surgery.

Classification
Surgeons have classified fractures by anatomical configuration and 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 (fragmentation), 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 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). Brief descriptions of five commonly cited classification systems are presented in Table 1 (Cooney 1993; Frykman 1967; Melone 1993; Muller 1991; Older 1965).

Open in table viewer
Table 1. Commonly used classification systems

Name (reference ID)

Brief outline

Comment

AO (Arbeitsgemeinschaft fur Osteosynthesefragen) (Muller 1991)

This system is organised in order of increasing fracture severity. It 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.

There is no assessment of the extent of fracture displacement.

Frykman
(Frykman 1967)

This system 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 (ulnar styloid) fracture. There are 8 types labelled I to VIII (1 to 8): the higher the number, the greater complexity of the fracture.

There is no assessment of the extent or direction of fracture displacement, or of comminution.

Melone
(Melone 1993)

This system identifies 5 fracture types, based on 4 major fracture components: the radial shaft, the radial styloid, and the dorsal‐medial and volar‐medial fragments.

This is for intra‐articular fractures only.

Older
(Older 1965)

This system divides fractures into 4 types, labelled I to VI (1 to 4) of increasing severity. The types are defined according to extent of displacement (angulation and radial shortening) and comminution.

There is no consideration of radio‐ulnar joint involvement.

'Universal Classification' (Cooney 1993)

This system divides fractures into 4 main types, labelled I to VI (1 to 4), distinguishing between extra‐articular and intra‐articular fractures and displaced and non‐displaced fractures. Displaced fracture types II and IV are further subdivided based on 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).

This does not distinguish between the radiocarpal and radio‐ulnar joints. Additionally, there is a 'trial by treatment'.

Description of the intervention: bone grafts and bone graft substitutes
In the last century, most distal radial fractures in adults were treated conservatively, by reduction (the alignment of the bony fragments) of the fracture when displaced, and stabilisation in a plaster cast or other external brace. The results of such treatment, particularly in older people with bones weakened by osteoporosis, are not consistently satisfactory (Handoll 2003b), and surgical interventions have been developed aimed at more accurate reduction and more reliable stabilisation. However, particularly in people with osteoporotic bone, metaphyseal comminution and impaction may result in a bone void in the distal radius that may be associated with loss of reduction and malunion. This defect can be filled with some biocompatible material; for example, an autograft (autogenous bone graft) that is obtained from the patients themselves. Such bone is 'harvested' or extracted from a donor site; usually the iliac crest (a part of the pelvic girdle). However, autograft harvesting carries a significant risk of complication, including donor site pain, haematoma, infection and nerve injury (Arrington 1996). A common alternative is an allograft (allogenic bone graft), obtained from cadaveric donors or live donors undergoing procedures such as total hip replacement. This avoids the morbidity associated with autografts but adds the risks of disease transmission and of engendering an immune response. However, the preparation of allografts (sterilisation and freeze drying for safe storage) eliminates bone‐forming cellular elements and reduces structural performance. Synthetic alternatives eliminate the risk of disease transmission but their properties vary considerably. Some, such as bone cement, are essentially space fillers and do not bond to the bone; others such as bioresorbable ceramics act as temporary scaffolds for new bone (osteoconduction) and are then absorbed during the healing process (Carson 2007). Bone grafts or substitutes are generally insufficient to maintain fracture reduction on their own and are often combined with fracture fixation such as Kirschner wires, plates and screws, or external fixators (typically metal pins or screws driven into the bone on either side of the fracture via small skin incisions and fixed externally with a plaster cast or an external fixator frame).

Complications
Complications from this injury are frequent (McKay 2001). 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). The etiology of complex regional pain syndrome type 1, also termed reflex sympathetic dystrophy (RSD), algodystrophy, Sudeck's atrophy and shoulder‐hand syndrome (Fernandez 1996), is often unclear. RSD is a major complication (Atkins 2003) requiring many months of physiotherapy to alleviate symptoms (pain and tenderness, impairment of joint mobility, swelling, dystrophy, vasomotor instability) in serious cases. Late complications include adaptive carpal instability (dynamic instability resulting from malalignment of distal radius and carpal bones within the wrist) that is associated with pain, decreased grip strength and clicking) and post‐traumatic arthritis which can occur several months or years after injury (Knirk 1986; Taleisnik 1984).

Complications can also result from treatment and include residual finger stiffness resulting from faulty application of plaster casts (Gartland 1951), and infection and tissue‐damage from surgery. Specific complications for bone grafts and substitutes include donor site morbidity for autografts, disease transmission from allografts, and problems resulting from soft‐tissue and intra‐articular deposits of bone substitute materials.

Why it is important to do this review?
A bony void is common after the reduction of many distal radial fractures. It is important to determine if inserting bone grafts and bone substitutes into this bony defect affects outcome, particularly in terms of function and adverse effects, either versus conservative treatment or surgical fixation or as an adjunct to methods of surgical fixation. The answer to this question is likely to depend on fracture configuration, bone quality and other patient factors.

Objectives

To evaluate the effectiveness of implanting bone scaffolding materials (bone grafts or bone substitutes) into bony defects resulting from fracture of the distal radius in skeletally mature people.

More specifically, we will compare the effectiveness of:

  • implanting bone scaffolding versus conservative treatment or surgical fixation (percutaneous pinning or external fixation or combinations of these);

  • implanting bone scaffolding used in conjunction with any method of surgical fixation versus the same method of surgical fixation alone;

  • different methods of bone scaffolding;

  • different types and durations of immobilisation after bone scaffolding.

We will consider outcome 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.

If data allow it, 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 evaluating the use of bone grafts or substitutes for treating distal radial fractures in adults.

Types of participants

Skeletally mature patients of either sex with a fracture of the distal radius. Trials containing adults and children will be included provided the proportion of children was clearly small (< 5%), or separate data for adults can be obtained. Trials containing different fracture types will only be included if separate data are available for participants with distal radial fractures. Also included will be trials recruiting people whose fractures have redisplaced within two weeks of conservative management.

Types of interventions

(1) Implantation of bone grafts or substitutes alone versus conservative interventions such as plaster cast immobilisation.
(2) Implantation of bone grafts or substitutes along with surgical fixation (percutaneous pinning, external fixation, internal fixation or combinations of these) versus the same method of surgical fixation alone.
(3) Implantation of bone grafts or substitutes alone versus surgical fixation (percutaneous pinning, external fixation, or combinations of these).
(4) Comparisons evaluating different types of bone scaffolding (e.g. autografts versus allografts; grafts versus bone substitutes; bioabsorbable versus bio‐inert substitute materials). This does not include comparisons of different preparations or compositions of the same broad category of bone substitutes.
(5) Comparisons evaluating different types and durations of immobilisation after bone scaffolding.

For the first three comparisons, the use of supplementary pinning solely to secure the placement of grafts/scaffolding will be considered on a case by case basis.

We will include trials in which surgery involving the insertion of bone grafts or substitutes takes place up to two weeks after initial conservative management.

This review does not cover bone tissue engineering and thus we will exclude trials evaluating bone scaffolding materials that are being used as delivery systems for biological agents, such as bone morphogenic proteins, involved in the bone remodelling process (Carson 2007). Also excluded are comparisons evaluating different surgical techniques associated with implantation of bone scaffolding; this decision may be revisited in the future.

Types of outcome measures

Our primary outcome of choice would be the number of people with an uncomplicated and swift 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 forearm 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), late tendon rupture 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 2.

    Open in table viewer
    Table 2. Definitions of key 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.

Intervention‐specific outcomes
For autografts, outcomes including pain and complications associated with the surgical removal of bone from the donor site will be collected, where reported, and presented in the analyses. Other adverse outcomes of bone scaffolding are already covered under 'Clinical outcome' (see above).

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): seeTable 3.

Open in table viewer
Table 3. 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 of Acta Orthopaedica Scandinavica Supplementum.

We will also scrutinise weekly downloads of "Fracture" articles in new issues of 15 journals (Acta Orthop Scand; Am J Orthop; Arch Orthop Trauma Surg; Clin J Sport Med; Clin Orthop; Foot Ankle Int; Injury; 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
Both 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
Using a data extraction form, both review authors will independently extract trial details and data for new trials, and one author (HH) will repeat data extraction of trials already included in Handoll 2003a and check for consistency with her previous data extraction. HH will enter the data into RevMan. Any disagreement for new trials will be resolved by discussion. 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 between groups in the pattern of functional recovery has been found at an intermediate assessment.

Assessment of methodological quality of included studies
Both review authors will independently assess methodological quality of the newly included trials using a pre‐piloted form. One author (HH) will reassess the trials already included in Handoll 2003a. Any disagreement will be resolved by discussion. 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, 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 4.

Open in table viewer
Table 4. 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
Quantitative data reported in individual trial reports for outcomes listed in the inclusion criteria will be presented in the text and in the analyses, using relative risks with 95% confidence intervals for dichotomous outcomes, and mean differences with 95% confidence intervals for continuous outcomes.

Unit of analysis issues
The unit of randomisation in these trials is usually the individual patient. Exceptionally, as in the case of trials including people with bilateral fractures, data for trials may be presented for fractures or limbs rather than individual patients. Where such unit of analysis issues arise and appropriate corrections have not been made, we will consider presenting the data for such trials only where the disparity between the units of analysis and randomisation is small. Where data are pooled, we will perform a sensitivity analysis to examine the effects of pooling these incorrectly analysed trials with the other correctly analysed trials.

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 and 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 bone scaffolding (such as bone graft versus bone substitute). To test whether the subgroups are statistically significantly different from one another, we will test the interaction using the technique outlined in 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. We will use the test of interaction to establish whether the subgroups are statistically significantly different from one another (Altman 2003).

Interpretation of the evidence
To assist our interpretation of the evidence, we will grade the findings of the treatment comparisons according to the six categories of effectiveness used by contributors to Clinical Evidence (BMJ 2006) (see Table 5).

Open in table viewer
Table 5. 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. Commonly used classification systems

Name (reference ID)

Brief outline

Comment

AO (Arbeitsgemeinschaft fur Osteosynthesefragen) (Muller 1991)

This system is organised in order of increasing fracture severity. It 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.

There is no assessment of the extent of fracture displacement.

Frykman
(Frykman 1967)

This system 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 (ulnar styloid) fracture. There are 8 types labelled I to VIII (1 to 8): the higher the number, the greater complexity of the fracture.

There is no assessment of the extent or direction of fracture displacement, or of comminution.

Melone
(Melone 1993)

This system identifies 5 fracture types, based on 4 major fracture components: the radial shaft, the radial styloid, and the dorsal‐medial and volar‐medial fragments.

This is for intra‐articular fractures only.

Older
(Older 1965)

This system divides fractures into 4 types, labelled I to VI (1 to 4) of increasing severity. The types are defined according to extent of displacement (angulation and radial shortening) and comminution.

There is no consideration of radio‐ulnar joint involvement.

'Universal Classification' (Cooney 1993)

This system divides fractures into 4 main types, labelled I to VI (1 to 4), distinguishing between extra‐articular and intra‐articular fractures and displaced and non‐displaced fractures. Displaced fracture types II and IV are further subdivided based on 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).

This does not distinguish between the radiocarpal and radio‐ulnar joints. Additionally, there is a 'trial by treatment'.

Figures and Tables -
Table 1. Commonly used classification systems
Table 2. Definitions of key 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 2. Definitions of key radiological parameters
Table 3. 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 3. Search strategies for CINAHL and EMBASE (OVID‐WEB)
Table 4. 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 4. Methodological quality assessment scheme
Table 5. 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 5. Categories of effectiveness (definitions)