Surgical interventions for treating tarsometatarsal (Lisfranc) fracture dislocations

  • Protocol
  • Intervention

Authors


Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To assess the effects (benefits and harms) of different surgical interventions for treating tarsometatarsal (Lisfranc) fracture dislocations.

Background

Description of the condition

The foot has a complex mechanical structure with 26 bones, 33 joints and over 100 muscles, tendons and ligaments. Traditionally, it has been divided into the hindfoot or heel (bones: talus, calcaneus), midfoot (bones forming the arch of the foot: cuboid, navicular and 3 cuneiforms) and forefoot (bones: 5 metatarsals and 14 phalanges) (Kelikian 2011).

The forefoot is connected to the midfoot through the tarsometatarsal joint complex; also called the Lisfranc joint complex after Jacques Lisfranc, a surgeon in Napoleon’s army (Lisfranc 1815). Stability and proper alignment of this joint complex are crucial for normal foot function and normal gait (Peicha 2002; Castro 2010). This stability is provided by bony and specialised ligamentous and tendon structures (dorsal, planter, and interosseous ligaments, insertions of the fibularis longus, tibialis anterior and tibialis posterior tendons, intrinsic muscles and plantar fascia) (De Palma 1997).

Of particular importance is the transverse (sideways) stability of the tarsometatarsal joint complex. Structurally, this is assisted by the positioning of the bones and the shape of the bases (upper ends) of the metatarsals and their corresponding cuneiform-cuboid articulations (joint surfaces) (Hardcastle 1982; Lu 1997; Kura 2001). While the third, fourth and fifth metatarsals are connected by intertarsal ligaments, transverse stability of the first and second metatarsals is only provided by the Lisfranc ligament, which extends obliquely from first cuneiform to the base of the second metatarsal. This ligament is of paramount importance for the stability of the tarsometatarsal joint complex (Preidler 1996; Solan 2001; Thompson 2003).

Injury to the tarsometatarsal joint complex can range from a mild sprain or subtle subluxations (partial dislocation) to significantly displaced and debilitating injuries (Myerson 1989). It was first described by Lisfranc in 1815 from his experience treating of injured cavalry men in the Napoleonic wars (Lisfranc 1815; Fischer 2005). He described how soldiers fell off their horses with their forefeet trapped in the stirrups, sustaining fracture dislocations to their midfeet (Esway 2006).

The mechanism of injury can be broadly classified as direct or indirect (Vuori 1993). A direct injury occurs when an external force, such as from the impact of a heavy object, is applied directly to the midfoot. This may result in displacement of the metatarsal bases, and is often associated with severe soft tissue damage (Thompson 2003; Smith 2005).

Indirect injury is more common and is often the result of a force applied to a downward-flexed foot, where the weight of the body act as a deforming force. Such injuries have been reported in high-energy motor vehicle or motorcycle accidents, falls from a height or down stairs and, as witnessed by Lisfranc, a fall from a horse with the forefoot held in a stirrup. Less severe injuries have also been reported in tackled football players, with windsurfing and snowboarding injuries (Myerson 2008), and even following a simple trip while jogging (Wright 2013)

Lisfranc injuries account for approximately 0.2% of all fractures with an incidence of 1/55,000 cases per year (Richter 2001; Desmond 2006). However, the incidence of these injuries appears to have been increasing over the last two decades, particularly since the introduction and routine use of airbags in motor vehicles (Smith 2005). People who previously might not have survived, now sustain severe blunt trauma to their lower extremities and feet, often resulting in dislocations of the midfoot and hindfoot (Loo 1996; Siegel 2001).

Accurate diagnosis of Lisfranc injuries can be difficult, and misdiagnosis or a delayed diagnosis occurs in up to 20% of cases, particularly in the subtle ligamentous injuries and subluxations (Kuo 2000; Lattermann 2007; Hatem 2008). Evaluation typically begins with clinical history and plain radiographs of the foot; however, because of overlapping bony structures on routine radiographic views, fractures can be easily missed and ligamentous injuries overlooked. Stress views or weight-bearing radiographs, computed tomography (CT) or magnetic resonance imaging (MRI) are often required in inconclusive cases (Preidler 1999; Rand 2000).

Quenu and Kuss first classified these injuries as homolateral, isolated or divergent based on the direction of the displaced metatarsals (Quenu 1909). Hardcastle 1982 modified the original classification into type A, B or C based on the degree of displacement and incongruity of the tarsometatarsal joints. This was further modified by Myerson 1986 adding subtypes and more proximal injures, acknowledging, however, that the outcomes and treatment did not correlate reliably with any injury type (see Appendix 1). To address the more subtle, mainly ligamentous, low-energy injuries seen in athletes, Nunley 2002 devised a classification system based on weight-bearing radiographs and bone scintigraphy (see Appendix 2).

Complications of injuries to the tarsometatarsal joint complex can be devastating; for example, post-traumatic arthritis and severe chronic foot pain. Whilst management strategies for treating these injuries lack consensus in the literature, there is agreement that early diagnosis and prompt treatment improve the final functional outcome (Mulier 2002; Ly 2006; Myerson 2008; Henning 2009; Stavlas 2010).

Description of the intervention

Non-surgical management with cast immobilisation is only recommended for non-displaced injuries (Pylawka 2008). Injuries with any degree of displacement are treated surgically, aiming for anatomical reduction and prevention of further displacement. This can be achieved through surgical fixation or fusion. There are three main methods: closed reduction and percutaneous fixation, open reduction and internal fixation (ORIF), and arthrodesis, performed as a primary intervention.

Closed reduction and percutaneous fixation

This comprises closed reduction (reduction by manipulation of bone through the skin) and the use of percutaneous (through the skin) Kirschner wires or cannulated screws to hold the reduction. Use of this method has been reported for simple tarsometatarsal fractures.

Open reduction and internal fixation (ORIF)

Open reduction (manipulation of bone after surgical exposure of the fracture) and internal fixation is considered the standard treatment for most Lisfranc injuries (Arntz 1988; Pérez Blanco 1988; Resch 1990). The techniques of ORIF vary; for example, Kirschner wire fixation, standard AO screw fixation (3.5 mm, 4.5 mm), bioabsorbable polylactide screws (Thordarson 2002) and dorsal plate fixation (Kuo 2000; Stavlas 2010; Scolaro 2011). A combination of techniques has often been used, particularly Kirschner wires fixation across the more mobile 4th and 5th tarsometatarsal joints and rigid screw fixation across the medial 1st, 2nd and 3rd joints (Arntz 1988).

Primary arthrodesis

Primary (initial procedure) arthrodesis (or fusion) of the midfoot involves fusing or stiffening the tarsometatarsal joint complex using pins, plates and screws so that the damaged bones heal into one continuous piece of bone. This procedure has been traditionally reserved as a salvage procedure for severely comminuted fractures and gross instabilities that have been considered at significantly high risk of post-traumatic arthritis.

Postoperative care

Following surgery, the foot is generally placed in a well-padded dressing with a plaster around the foot and lower leg or a removable boot for two weeks, when any sutures are removed. Patients remain non-weight bearing in a short leg cast or boot for an additional 4 to 10 weeks, depending on the injury and surgery. When used, temporary K-wires are typically removed at six weeks or before weight-bearing is allowed, in order to prevent pin breakage.

How the intervention might work

The treatment of tarsometatarsal fracture dislocations has evolved over the years from closed reduction and cast immobilisation to the current standards of open reduction and stable internal fixation with emphasis on anatomic joint restoration. Whilst the outcomes of these injuries have improved slightly over the years, they remain relatively poor and the treatment strategies are likely to continue evolving. The main goal of treatment is to have a functional foot, i.e. a painless, stable, plantigrade foot. This is achieved by restoring and maintaining the anatomical relationships of both bony and ligamentous structures (Alberta 2005; Lattermann 2007; Watson 2010).

Post-traumatic arthritis is the most common complication of tarsometatarsal fracture dislocations, often leading to deep aching midfoot pain aggravated by activity (Sangeorzan 1990; Schepers 2010). Indeed, a key aim of surgical intervention is to reduce the risk of post-traumatic arthritis. However, there is no evidence to correlate the severity of injury, or degree or pattern of displacement with the final functional outcome (Siegel 2001; Teng 2002; Stavlas 2010).

Closed reduction and percutaneous fixation is the least invasive surgical option but lack of direct visualisation of these generally complex injuries means that it is generally considered for simple tarsometatarsal fractures. Generally, closed reduction is considered ineffective in maintaining articular congruity (Myerson 1989; Trevino 1995; Buzzard 1998; Wagner 2013).

Although a more invasive procedure than closed reduction, open reduction and internal fixation (ORIF) facilitate better assessment and manipulation of the dislocated anatomy and more accurate fixation of the reduced parts, included articular fractures. The use of dorsal plates (e.g. one-fourth tubular plate) seems to have the theoretical advantage of rigid fixation without transarticular screws avoiding damage to the articular cartilage (Alberta 2005).

Given it is a more drastic procedure, which substantially alters foot mechanics, primary arthrodesis is typically reserved for more substantial injuries, where there are major questions on whether fixation that restores the anatomy is sufficient for a satisfactory long-term outcome.

Why it is important to do this review

Tarsometatarsal fracture dislocations vary in their severity and can have poor outcomes. There are several different surgical interventions available and in current use. Thus there is a need to inform practice by systematically reviewing the evidence for the use of these different surgical interventions. A recent review comparing primary fusion with internal fixation concluded that these methods were equivalent (Sheibani-Rad 2012). However, to our knowledge, there has been no systematic review of randomised clinical trials that focuses on all surgical treatments of tarsometatarsal (Lisfranc) fracture dislocations in adults.

Objectives

To assess the effects (benefits and harms) of different surgical interventions for treating tarsometatarsal (Lisfranc) fracture dislocations.

Methods

Criteria for considering studies for this review

Types of studies

We will include randomised and quasi-randomised (using a method of allocating participants to a treatment that is not strictly random, e.g. by hospital number) controlled clinical trials evaluating surgical interventions for treating tarsometatarsal (Lisfranc) fracture dislocations.

Types of participants

We will include adults with tarsometatarsal fracture dislocations. We will include all severities of fracture, both open and closed, dislocation, and joint and ligamentous injuries.

We will exclude trials that specifically focus on treating people with a primary bone disease (e.g. fibrous dysplasia), pathological fractures (from metastatic cancer) or periprosthetic fractures. Trials including children or patients with primary bone diseases or pathological fractures will be excluded unless separate data can be provided for adults with non-pathological fractures, or the proportion of children or adults with primary bone diseases or pathological fractures is small (less than 5%). We will exclude trials comparing different interventions for complex foot injuries; for example, injuries to the whole foot including tarsometatarsal joints, forefoot and hindfoot injuries.

Types of interventions

We will include trials comparing different surgical interventions for the treatment of tarsometatarsal (Lisfranc) fracture dislocations. Trials comparing surgical with non-surgical interventions will be excluded. As described in the Description of the intervention, the main interventions under consideration are:

  1. Closed reduction and percutaneous fixation

  2. Open reduction and internal fixation (ORIF)

  3. Primary arthrodesis

Trials evaluating other interventions such as the use of mini-external fixators or surgical staples will also be included. Finally, trials comparing modified surgical techniques of the same intervention, such as different types of fixation (e.g. screw versus wire fixation) or different arthrodesis techniques, will also be included.

When selecting the 'control' group or any comparison, we will first select on 'standard or traditional practice'. Thus we will consider ORIF our control group in comparisons of closed reduction versus ORIF or primary arthrodesis versus ORIF. Should this not be clear, we will select the less invasive or less technically demanding intervention as the control.

Types of outcome measures

Primary outcomes
  1. Functional assessment, including lower-limb specific validated clinical scores (e.g. American Orthopaedic Foot and Ankle Society Score (Kitaoka 1994), Baltimore Painful Foot Score (Mulier 2002), Visual-Analogue-Scale Foot and Ankle (Richter 2006))

  2. Failure of treatment requiring secondary surgical procedures (e.g. non-union, malunion, painful stiff foot, persistent instability of the foot, symptomatic post-traumatic arthritis, heterotopic ossification and problematic prominent hardware, symptomatic hardware breakage)

  3. Persistent pain, preferably assessed using self-reported scales, e.g. visual analogue scale; or complex regional pain syndrome (characterised by pain involving the injured foot, hyperaesthesia, and localised autonomic dysfunction)

Secondary outcomes
  1. Adverse events (e.g. superficial wound infection, deep infection, deep vein thrombosis)

  2. Patient-reported health-related quality of life measures (e.g. SF-36)

  3. Return to work and former activities, such as sport

  4. Patient satisfaction, including the cosmetic result

  5. Resource use and other costs (e.g. hospital stay, number of outpatient attendances, physiotherapy and other costs)

Timing of outcome assessment

When possible, outcomes will be reported for the short term (up to 6 weeks), medium term (7 to 26 weeks) and long term (over 26 weeks).

Search methods for identification of studies

Electronic searches

We will search the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register (to present), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, current issue), MEDLINE (1946 to present) and EMBASE (1974 to present). We will also search Current Controlled Trials, ClinicalTrials.gov and the WHO International Clinical Trials Registry platform for ongoing and recently completed trials. There will be no restriction on the inclusion of reports based on publication language.

In MEDLINE, the subject specific search strategy will be combined with the sensitivity-maximising version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (Lefebvre 2011). Search strategies for The Cochrane Library, MEDLINE and EMBASE can be found in Appendix 3.

Searching other resources

We will check reference lists of included articles. We will also attempt to contact researchers in the field for information on existing or ongoing trials. Specific proceedings of foot and ankle surgery meetings and conferences will be searched from the following organisations: British Orthopaedic Foot and Ankle Society (BOFAS), American Orthopaedic Trauma Association annual meetings (1996 onwards) and American Academy of Orthopaedic Surgeons annual meetings (2010 onwards).

Data collection and analysis

Selection of studies

Two review authors will independently examine the titles and abstracts of articles identified in the search as potentially relevant trials. Full texts of trials that fulfil our inclusion criteria and those that are unclear from perusal of the abstracts will be obtained. The same two review authors will independently perform study selection. Any disagreement will be discussed and, if necessary, a third author will arbitrate. The review authors will not be blinded to the journal or study authors.

Data extraction and management

For each included trial, two review authors will independently extract data using a pre-piloted form. This will include demographic data and all reported outcome measures both binary and continuous data. We will compile a comprehensive 'Characteristics of included studies' table that will provide key information for each included trial. Any differences in data extraction will be resolved by consensus, and by referring back to the original article. Disagreements will be resolved by discussion and, where necessary, in consultation with another review author.

Assessment of risk of bias in included studies

The risk of bias of the included studies will be independently assessed by two review authors using the The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2011). We will assess the following domains:

  1. random sequence generation;

  2. allocation concealment;

  3. blinding of participants and personnel;

  4. blinding of outcome assessment;

  5. completeness of outcome data;

  6. selective reporting;

  7. other bias (e.g. major baseline imbalance; and risk of bias associated with inexperience of surgeons and other care providers with the interventions, and differences in rehabilitation).

Each of these domains will be judged at being at low risk of bias; high risk of bias; or unclear risk of bias (either lack of information or uncertainty over the potential for bias). Disagreements between authors regarding the risk of bias for domains will be discussed and resolved by consensus and, where necessary, a third author will arbitrate.

Measures of treatment effect

The treatment effects will be expressed as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes. Treatment effects for continuous outcomes will be expressed as mean differences (MD) and 95% CI for single studies or for two or more studies with comparable outcome measures. Standardised mean differences (SMD) and 95% CI will be used for pooling continuous data from disparate outcome measures.

Unit of analysis issues

We anticipate that the unit of randomisation and analysis in the included trials will be the individual patient. Although the unit of randomisation in these trials is usually the individual patient, trials including people with bilateral Lisfranc fracture dislocations may present results for fractures or limbs rather than individual patients. Where such unit of analysis issues arise and appropriate corrections have not been made, we will present the data for such trials if the disparity between the units of analysis and randomisation is small. When data are pooled, we will perform a sensitivity analysis to examine the effects of excluding incorrectly reported trials from the analysis.

We will avoid unit of analysis issues related to repeated observations of the same outcome, such as results presented for several periods of follow-up.

Dealing with missing data

We will try to contact the authors of primary studies to request missing data, such as number of participants, details of drop-outs, means, measures of uncertainty (standard deviation or error) or number of events. Where possible, we will extract data to allow an intention-to-treat analysis in which all randomised participants are analysed in the groups to which they were originally assigned. If there is discrepancy in the number randomised and the numbers analysed in each treatment group, we will calculate the percentage loss to follow-up in each group and report this information. If drop-outs exceed 10% for any trial, we will assign the worst outcome to those lost to follow-up for dichotomous outcomes. Further, we will assess the impact of this in sensitivity analyses with the results of those who completed the trial. For continuous outcomes with no standard deviations reported, we will calculate standard deviations if possible from standard errors, P values or confidence intervals, according to the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). If we are unable to calculate standard deviations, missing values will not be imputed.

Assessment of heterogeneity

We will judge clinical heterogeneity between trials for all comparisons, and visually inspect graphs in order to investigate the possibility of statistical heterogeneity. This will be supplemented by the I² statistic, which provides an estimate of the percentage of variability due to heterogeneity rather than to chance alone. An I² estimate equal to or greater than or equal to 75% indicates the presence of high levels of heterogeneity (Higgins 2011).

Assessment of reporting biases

We will explore the possibility of publication bias using a funnel plot if data from over 10 trials are available for pooling.

Data synthesis

If appropriate, we will pool the results of comparable groups of trials using both fixed-effect and random-effects models. The choice of the model to report will be guided by careful consideration of the extent of heterogeneity and whether it can be explained, in addition to other factors, such as the number and size of included studies. Ninety-five per cent confidence intervals will be used throughout. We will consider not pooling data where there is considerable heterogeneity (I² > 75%) that cannot be explained by the diversity of methodological or clinical features among trials or where the outcome measures differ. Where it is inappropriate to pool data, we will still present trial data in the analyses or tables for illustrative purposes and will report these in the text.

Subgroup analysis and investigation of heterogeneity

Where the data allow, we plan to conduct the following subgroup analyses:

  • Open versus closed injuries: often open injuries have higher risk of complications, particularly infection

  • Isolated Lisfranc versus presence of additional foot/ankle injuries: additional injuries will make the management of these injuries more complex

  • Young adults versus older adults (generally over 65 years): older populations will generally have other co-morbidities such as osteoporosis and osteoarthritis

  • Participants who are smokers versus non-smokers; smokers are more susceptible to complications such as infection and impaired tissue healing

We will investigate whether the results of subgroups are significantly different by inspecting the overlap of confidence intervals and performing the test for subgroup differences available in Review Manager software (RevMan 2014).

Sensitivity analysis

Where possible, we plan sensitivity analyses examining various aspects of trial and review methodology, including the effects of missing data, and of excluding trials at high or unclear risk of bias, such as selection bias arising from the lack of allocation concealment, and trials only reported in conference abstracts, and the selection of the statistical model (fixed effect versus random effects). For multiple trial comparisons with substantial heterogeneity, sensitivity analyses to explore the effects on heterogeneity and outcome of the removal of outliers may be considered.

Quality of the evidence and 'Summary of findings' tables

We shall use the GRADE approach to assess the quality of evidence related to each of the primary outcomes listed in Types of outcome measures (Higgins 2011; section 12.2). Where there are sufficient data, we will summarise the results for the comparisons of main interventions described in Types of interventions in 'Summary of findings' tables.

Acknowledgements

We would like to thank Mario Lenza and Alasdair Sutherland for peer reviewing this protocol, and Helen Handoll and Laura MacDonald for helpful comments about drafts of this protocol. We are also grateful to Joanne Elliott for developing the search strategies.

Appendices

Appendix 1. Myerson's modification of Quénu & Küss/Hardcastle Classification System for Lisfranc Fracture Dislocations

Type A injuries: homolateral

Displacement of all five metatarsals with or without fracture of the base of the 2nd metatarsal

Displacement is lateral or dorsolateral, and the metatarsals move as a unit

Type B injuries: isolated

One or more articulations remain intact

Type B1 injuries: medially displaced, may involve the intercuneiform or naviculocuneiform joint

Type B2 injuries: laterally displaced, may involve the 1st metatarsal-cuneiform joint

Type C injuries: divergent

High-energy injuries, associated with significant swelling, prone to complications, especially compartment syndrome

Type C1 injuries: partial

Type C2 injuries: complete

Appendix 2. Nunley & Vertullo Classification of Midfoot Sprains

Stage I

Sprain of the Lisfranc ligament with no measurable diastasis between the medial cuneiform and the base of the 2nd metatarsal or loss of arch height on weight-bearing radiographs.

Positive bone scan with increased uptake.

It may represent a dorsal capsular tear and sprain without elongation of the Lisfranc ligament. The Lisfranc complex is stable.

Stage II

Diastasis of 1 to 5 mm between the base of the 2nd metatarsal and the medial cuneiform. No loss of arch height on weight-bearing radiographs.

Elongation or disruption of the Lisfranc ligament can be present, but the plantar capsular structures remain intact.

Stage III

Diastasis of > 5 mm between the base of the 2nd metatarsal and the medial cuneiform. Loss of arch height on weight-bearing radiographs represented by a decreased distance between the planter aspect of the 5th metatarsal and the medial cuneiform on lateral radiograph.

Appendix 3. Search strategies

The Cochrane Library (Wiley Online Library)

#1 ((Lisfranc* or tarsometatars* or tars*-metatars* or midfoot) near/3 (fracture* or dislocat* or injur* or trauma*)):ti,ab,kw (Word variations have been searched)
#2 MeSH descriptor: [Metatarsus] this term only and with qualifier(s): [Injuries - IN]
#3 MeSH descriptor: [Tarsal Joints] this term only and with qualifier(s): [Injuries - IN]
#4 #1 or #2 or #3

MEDLINE (Ovid Online)

1 ((Lisfranc* or tarsometatars* or tars*-metatars* or midfoot) adj3 (fracture* or dislocat* or injur* or trauma*)).tw.
2 Metatarsus/in [Injuries]
3 Tarsal Joints/in [Injuries]
4 or/1-3
5 Randomized controlled trial.pt.
6 Controlled clinical trial.pt.
7 randomized.ab.
8 placebo.ab.
9 Drug therapy.fs.
10 randomly.ab.
11 trial.ab.
12 groups.ab.
13 or/5-12
14 exp Animals/ not Humans/
15 13 not 14
16 4 and 15

EMBASE (Ovid Online)

1 ((Lisfranc* or tarsometatars* or tars*-metatars* or midfoot) adj3 (fracture* or dislocat* or injur* or trauma*)).tw.
2 Tarsometatarsal Joint/
3 1 or 2
4 Randomized controlled trial/
5 Clinical trial/
6 controlled clinical trial/
7 Randomization/
8 Single blind procedure/
9 Double blind procedure/
10 Crossover procedure/
11 Placebo/
12 Prospective study/
13 ((clinical or controlled or comparative or placebo or prospective* or randomi#ed) adj3 (trial or study)).tw.
14 (random* adj7 (allocat* or allot* or assign* or basis* or divid* or order*)).tw.
15 ((singl* or doubl* or trebl* or tripl*) adj7 (blind* or mask*)).tw.
16 (cross?over* or (cross adj1 over*)).tw.
17 ((allocat* or allot* or assign* or divid*) adj3 (condition* or experiment* or intervention* or treatment* or therap* or control* or group*)).tw.
18 RCT.tw.
19 or/4-18
20 Case Study/ or Abstract Report/ or Letter/
21 19 not 20
22 3 and 21

Contributions of authors

HM: conceiving the review, designing and writing the protocol. HM is also the guarantor of the review.
HA: conceiving the review, designing and writing the protocol.
ET: providing general advice on drafts of the protocol.
PA: providing general advice on drafts of the protocol.
MD: conceiving the review, designing and writing the protocol.

Declarations of interest

HM: none known
HA: none known
ET: none known
PA: none known
MD: none known

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