Surgery for Dupuytren's contractures of the fingers
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects (benefits and harms) of different surgical procedures for the treatment of Dupuytren's contracture of the index, middle, ring and little fingers (the thumb will be excluded, as cords form on the radial aspect of the thumb, and thus are not readily accessible in terms of angular deformity of the thumb's joints. Furthermore, thumb disease is also rare, and does not usually cause disability, hence it is uncommonly treated).
Background
Description of the condition
Dupuytren's disease may affect the hand and the sole of the foot. In the hand it is characterised by slow but progressive fibroproliferative changes associated with the palmar aponeurosis, which lies beneath the skin of the palm, and its extensions into the fingers (Hurst 2000). Whilst it most commonly involves the ring and little fingers and the thumb, it can affect any digit. In the early stage of the condition, nodules of Dupuytren's tissue form in association with the palmar aponeurosis. These may coalesce to form cords of Dupuytren's tissue that run to the fingers. The cords may shorten and prevent full extension of the finger, thus preventing patients from placing their hands flat on a surface. They may then complain of difficulty in putting on gloves, face washing or in other dextrous tasks. If left untreated, this restriction of finger extension usually progresses, though the rate of progression is unpredictable. These changes are irreversible without treatment (Luck 1959). Loss of motion, particularly functional extension, results in activity limitation and motivates the patient to seek surgical opinion (Pratt 2009).
The prevalence of Dupuytren's disease varies with geographic location, sex and age. It is unusual under the age of 50 years and is more common in men, though this sex difference may diminish with increasing age. Its prevalence is highest in men of Northern European origin, and the prevalence in British men and women over the age of 75 may be as high as 18%, and 9%, respectively (Early 1962).
The aetiology of Dupuytren's disease is not fully understood. A higher prevalence amongst family members has been accepted for a long time (Yost 1955) and it is also associated with diabetes mellitus and smoking (Burge 1997). However, the proposed association with epilepsy is unclear (Geoghegan 2004). Furthermore, reported associations with socio‐economic factors and manual work are also controversial (Early 1962, Herzog 1951).
Whilst typical patients experience slow progression of disease and a good response to intervention, some experience aggressive disease progression, often from an early age, and may experience earlier recurrence. The term "Dupuytren's diathesis" has been coined to describe this (Hueston 1963). The benefit of treatment may also be affected by the anatomical location of the disease within the hand, with proximal interphalangeal joint treatment improving hand function more than metacarpophalangeal joint correction in one study (Draviaraj 2004). However, actually achieving correction at the proximal interphalangeal joint is more difficult: whereas metacarpophalangeal joint contractures can usually be fully corrected with surgery, proximal interphalangeal joint contractures are frequently only incompletely corrected. Consequently, there is heterogeneity in terms of both disease presentation within the digits, response to surgery, and functional benefit from the response to surgery.
There is no cure for Dupuytren's disease, which would require removal of Dupuytren's tissue from the palm of the hand and the flexor surfaces of the digits, and inhibition of subsequent disease formation. Instead, the primary treatment aim is to excise, divide, break or dissolve cords of Dupuytren's tissue that are preventing full finger extension. This aims to improve or correct the finger contracture (loss of extension). However, as some cells that produce Dupuytren's tissue are inevitably left throughout the hand and within the region of the treated cord, Dupuytren's contractures can form at other sites in the hand in the future (disease extension) or a "recurrent contracture" may develop within the operation site. Treatment is usually offered before the affected finger has contracted so far that hand function is significantly impaired. This is because small contractures that have recently developed have a better chance of correction than long‐standing severe contractures, which may have allowed secondary joint stiffness to develop in the underlying "flexed" joints. A 30° metacarpophalangeal joint contracture is often cited as a threshold for offering surgery (BSSH 2010). Such a figure may be chosen as less significant contractures might not be expected to cause functional impairment, and because of the belief that surgery itself might stimulate disease progression (Bisson 2003). However, the scientific basis for this is not proven.
Non‐operative strategies include radiotherapy, splinting and ultrasonography. The value of radiotherapy for established contractures is uncertain; splinting and ultrasonography are ineffective. A novel approach is to inject collagenase into the Dupuytren's cords causing the finger contracture (Hurst 2009). The collagenase is synthesised by Clostridium histolyticum and degrades the collagen within the Dupuytren's cords, thus weakening them so that they can be broken by forced extension of the affected finger on the following day. The Food and Drug Administration (FDA) have approved it for use in the USA (FDA 2010), and it is now licensed for use in the European Union, though its role has not yet been fully evaluated (Thomas 2010).
The present mainstay of treatment for Dupuytren's contracture is surgery, and many different surgical options have been described for Dupuytren's disease. These began with Baron Dupuytren's description of surgical release of the contracture, performed without anaesthesia in 1831 (Elliot 1999). Common operative strategies are described below, in order of the extent of the surgery and starting with the least invasive. Their relative benefits and disadvantages are summarised.
Description of the intervention
Needle Fasciotomy (aponeurotomy)
This involves blind division of the contracture with a hypodermic needle (usually 25 gauge). This concept dates back to the time of Dupuytren himself, though it has experienced a resurgence in popularity since the 1990s (Badois 1993). The benefits of this procedure include that it can be performed in clinic on an outpatient basis, and so may be cost effective; it may also have a rapid recovery rate. Its disadvantages include that it may have a significant recurrence rate of 75% or more at five years (van Rijssen 2006a; van Rijssen 2012), and that it carries the risk of tendon and digital nerve and artery damage. Although most surgeons agree that this procedure has a role in managing Dupuytren's disease causing a contracture of the metacarpophalangeal joint, it is less popular for the treatment of Dupuytren's cords in the finger that are causing contractures of the proximal interphalangeal joint. This is due to the risk of damage to the digital nerves and flexor tendons in the finger and the inability to reliably release contractures of the proximal interphalangeal joints. A six‐week follow‐up study suggested that it might be a reasonable alternative to limited fasciectomy in the short term management of selected cases (van Rijssen 2006b), accepting that there is significantly higher recurrence after needle aponeurotomy compared to fasciectomy, and that this recurrence tends to occur quicker. This was seen in the five‐year follow up data from the same study (van Rijssen 2012).
Very limited fasciectomy (segmental aponeurectomy)
Small incisions are made over the portions of the Dupuytren's cord that are causing the contracture and segments of this are excised such that the finger straightens (Moermans 1991). No attempt is made to remove all of the cord causing the contracture. The benefit of this procedure is that it is relatively less invasive with a quick (two or three week) recovery period. However it is performed in an operating theatre and is thought to be associated with a high recurrence rate for Dupuytren's contracture, up to 38% (Moermans 1996). This may be because significant deposits of Dupuytren's tissue persist in the hand and finger. Although most surgeons agree that this procedure has a role for Dupuytren's disease in the palm of the hand which is causing a contracture of the metacarpophalangeal joint, it is less popular for the treatment of cords in the finger itself, which cause contractures of the proximal interphalangeal joint. This is because of the risk of damage to the digital nerves and the inability to reliably release contractures of the proximal interphalangeal joints.
Limited fasciectomy
In this procedure the surgeon aims to remove all of the Dupuytren's cord that is causing the finger contracture. This is the most popular treatment for Dupuytren's disease in the recent past but it carries a significant recurrence rate and has a relatively long rehabilitation phase (four to six weeks). Furthermore it carries a small, though significant, risk of complications such as diffuse finger stiffness, which may involve not only the operated finger, but also the other fingers of the hand. The recurrence rate following limited fasciectomy may exceed 20% at five years (van Rijssen 2012), possibly because disease‐forming cells are retained in the subcutaneous fat and skin, and may form "recurrent" contractures.
Dermofasciectomy
This is a more extensive procedure in which all of the Dupuytren's cord causing the contracture is excised. In addition, all the subcutaneous fat and skin on the palmar aspect of the proximal and middle pulp spaces of the finger (overlying the cord) are excised, leaving only the flexor tendon sheath and the two neurovascular bundles. The resultant skin defect is covered with a full thickness skin graft, which is usually harvested from the medial border of the forearm or upper arm, the front of the elbow or the ulnar aspect of the hand. The proponents of this procedure claim that, by excising skin and subcutaneous fat, which may be involved with Dupuytren's disease, the rate of recurrence of a Dupuytren's contracture is reduced (Armstrong 2000). Many surgeons selectively use this procedure in young patients or those with the "diathesis", in whom the risk of recurrence in later life is high. The specific disadvantages of dermofasciectomy are that it has a longer rehabilitation phase and requires the harvest of a skin graft. Specific complications include loss of the skin graft and, as for limited fasciectomy, complications such as finger stiffness and Complex Regional Pain Syndrome can occur.
How the intervention might work
Surgery, either by excision or division of the Dupuytren's cord, should allow immediate full extension of the affected joint(s), assuming that the underlying joint has not developed a fixed flexion deformity for other reasons (e.g. collateral ligament contraction, check rein ligament shortening, or arthritis).
Why it is important to do this review
There is a need for a comparative analysis of the outcomes of the different surgical treatment options for Dupuytren's disease to investigate whether more invasive procedures, such as dermofasciectomy, have lower "recurrent contracture" rates, and whether any such benefit is outweighed by a higher rate of adverse events (complications) or an unacceptably longer or more difficult rehabilitation period. Whilst comparison of different operative techniques is important, it must be recognised that surgery is only part of a complex intervention for the treatment of Dupuytren's contracture. The outcome of this may not be exclusively determined by what surgery is performed, but also by the post‐operative rehabilitation regime (splintage and hand therapy) and other treatment factors such as patient selection and site of contracture (metacarpophalangeal joint alone, proximal interphalangeal joint alone, or both joints together). Also the outcome of Dupuytren's surgery is usually defined by the "recurrent contracture rate", (in contrast to "disease extension" to other digits, the rate of which is unaffected by surgery). Only a few studies have assessed outcome with patient centred outcome tools, or investigated the severity and length of the post‐operative recovery from the surgery.
Objectives
To assess the effects (benefits and harms) of different surgical procedures for the treatment of Dupuytren's contracture of the index, middle, ring and little fingers (the thumb will be excluded, as cords form on the radial aspect of the thumb, and thus are not readily accessible in terms of angular deformity of the thumb's joints. Furthermore, thumb disease is also rare, and does not usually cause disability, hence it is uncommonly treated).
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) will be included, irrespective of language or sample size. Quasi‐randomised and non‐blinded studies will also be included.
Types of participants
Adult men and women from all ethnic origins, with or without risk factors for Dupuytren's disease, who have undergone a surgical procedure for primary (not recurrent) Dupuytren's contracture of one or more of the index, middle, ring and little fingers.
Types of interventions
Any surgical intervention, including percutaneous needle fasciotomy (aponeurotomy), very limited fasciectomy, limited fasciectomy and dermofasciectomy. Comparators will include the alternative surgical procedures, placebo/sham surgery and other active non‐surgical treatments (collagenase injection, hand therapy, physiotherapy, radiotherapy).
Types of outcome measures
Major outcomes
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Improvement in contracture immediately after surgery ‐ the difference between the finger angle measurement immediately after surgery and the preoperative finger angle measurement.
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Residual contracture immediately after surgery ‐ as assessed by angle measurement (goniometry).
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Early result at time of discharge from care.
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Recurrence of Dupuytren's disease/contracture in the operated field. As recurrence is time‐dependent, length of follow‐up is not standardised and there is no universally agreed definition of recurrence, recurrence rates and length of follow‐up will be described in narrative form for each study. Where appropriate data exists, time‐to‐event analyses will be performed. However, it is not expected that these data will be available. Meta‐analyses will only be performed for studies with similar definitions of recurrence and recurrence data at similar follow‐up times after surgery ('similar definitions of recurrence' will include those with recurrence involving 20 to 30º increase in angles compared to early discharge data or preoperative data). The minimum length of follow‐up for eligibility in this analysis will be 18 months. This has been chosen based on two considerations: shorter follow‐up gives insufficient time for recurrences to occur. Secondly, there is no current consensus to define minimum length of follow‐up, and this varies widely in published studies ranging from three weeks to 13 years (Becker 2010).
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Adverse effects of surgery. Anticipated ones include loss of finger flexion, loss of finger sensation due to digital nerve injury, vascular compromise, delayed healing and infection. As the extent of reported adverse events is unknown, the total adverse effects data will be collected and reviewed. Reviewers will focus on an agreed five key adverse events should these prove to be extensive.
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Time to regain hand function after intervention, as assessed by validated outcome measures such as DASH (Disabilities of the arm, shoulder and hand) (Hudak 1996), PEM (Patient Evaluation Measure) (Macey 1995) and other self‐report questionnaires, grip strength, Jebsen‐Taylor Hand Function Test (Jebsen 1969).
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Level of hand function restored as assessed by the DASH, PEM, grip strength, Jebsen‐Taylor Hand Function Test. We are uncertain which standardised outcome instruments we will encounter but all will be reported.
Minor outcomes
Economic cost of intervention. Where provided this will be assessed as the total documented cost of the procedure and rehabilitation. Where time‐to‐recurrence has been documented, cost per year of recurrence‐free survival will be calculated. However, it is not anticipated that these data will be available.
Search methods for identification of studies
Electronic searches
We will search the following electronic databases to find reports of relevant RCTs and CCTs:
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Cochrane Wounds Group Specialised Register
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The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, current issue
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BNI (British Nursing Index and Archive) ‐ 1985 to current date
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CINAHL ‐ 1981 to current date
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EMBASE ‐ 1980 to current date
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LILACS (Latin American and Caribbean Health Sciences ) ‐ 1982 to current date
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Ovid MEDLINE ‐ from 1948 to current date
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Ovid MEDLINE ‐ In‐Process and other Non‐Indexed Citations ‐ from 1948 to current date
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Proquest (ABI/INFORM Global and Dissertations & Theses)‐ all entries to current date
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Sciverse ‐ 1823 to current date
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Zetoc ‐ 1993 to current date
The full search strategy for CENTRAL is in Appendix 1.
The Ovid MEDLINE search will be combined with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity‐ and precision‐maximizing version (2008 revision) (Lefebvre 2011): Ovid format (see Appendix 2 for the full strategy). The EMBASE and CINAHL searches will be combined with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN) (SIGN 2011). There will be no restrictions on the basis of language or date of publication.
Variations of the Ovid MEDLINE search strategy will be used to search the other databases listed above.
Searching other resources
The reference lists of short listed articles will be reviewed to identify additional suitable studies and Web of Science will be searched to identify studies which cite the items in the shortlist. No language restrictions will be applied and potentially eligible foreign language studies will be translated.
National and international trials registers will also be searched (Clinicaltrials.gov, WHO, Dutch and any others).
The last 10 years content of the journals listed, including conference reports and abstracts will be reviewed to identify abstracts of eligible studies, which may have subsequently been published as full papers:
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Journal of Hand Surgery (British and European);
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Journal of Hand Surgery (American);
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Journal of Bone and Joint Surgery (British);
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Journal of Bone and Joint Surgery (American);
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Journal of Plastic, Reconstructive and Aesthetic Surgery;
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Hand Clinics.
Data collection and analysis
Selection of studies
From the title, abstract or descriptor, two authors (JR, GB) will independently screen all abstracts to identify potential studies for review using a checklist of the criteria for inclusion (see Criteria for considering studies for this review). The two authors will compare their lists of potential studies and produce an agreed shortlist. Copies of the full articles of the papers on the agreed shortlist will be obtained.
Two review authors (JR, GB) will independently review the full text of the abstracts of the "agreed shortlist" papers and identify those suitable for inclusion using the selection checklist (Criteria for considering studies for this review). Disagreements will be resolved by referral to a third author (TD) and discussion. Titles of journals, names of authors or supporting institutions will not be masked.
Data extraction and management
Data regarding source, study design, intervention, population and outcomes will be extracted using a piloted form by two authors (JR, CB) independently. Disagreements will be resolved by consensus after an additional review by a third author (WZ).
Assessment of risk of bias in included studies
The Cochrane Collaboration's tool for assessing risk of bias will be used by two authors (HG, JH) independently (Higgins 2011). All seven domains (sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective outcome reporting and other issues) of this tool will be assessed allowing classification of domains into 'high risk of bias', 'low risk of bias' or 'unclear risk of bias' (see Appendix 4). The judgement by outcome will be based upon the majority of the seven domains fitting either high or low risk. Disagreements will be resolved by referral to a third author and discussion.
Measures of treatment effect
We will use standardised mean differences (SMD) to combine different outcome measures from different trials (Hedges 1982).
In studies that report dichotomous data, risk ratios with 95% confidence intervals will be calculated. For rare events (<10%), Peto odds ratios with 95% confidence intervals will be calculated. Results will be combined for meta‐analysis using the fixed effects or random effects models depending on heterogeneity (see Data Synthesis).
Unit of analysis issues
It is expected that most studies will use the hand as the unit of randomisation. Assessing outcomes such as hand function would not be possible if individual fingers from the same hand were used as the unit of randomisation. The unit of randomisation (patient, hand, finger or unclear) will be recorded for each eligible study.
It is not expected that there will be any crossover studies, given that the interventions here are single stage definitive treatments. Cluster randomised studies are not expected to be found.
Dealing with missing data
We envisage there being two types of missing data: unreported and withdrawn. When there is unreported data in included trials, we will contact authors to seek assistance. No imputation will be attempted.
Assessment of heterogeneity
Statistical heterogeneity will be tested using visual inspection of graphs, chi‐squared and I2 statistic tests. A chi‐squared test result will be considered to be significant when P < 0.10. An I2 test result greater than 50% will be classed as substantial heterogeneity.
Assessment of reporting biases
To reduce the risk of reporting bias, multiple sources will be searched, including Proquest (ABI/INFORM Global and Dissertations & Theses), to identify all published and unpublished results possible.
Funnel plots will be drawn to assess the risk of publication bias.
Abstracts from presentations at the previous 10 years of meetings of the International Federation of Societies for Surgery of the Hand (IFSSH), American Society for Surgery of the Hand (ASSH), American Association for Hand Surgery (AAHS), Federation for European Societies for Surgery of the Hand (FESSH) and the British Society for Surgery of the Hand (BSSH) will also be screened to identify relevant results that have not been published. If such work is identified, the authors will be contacted and asked to provide a copy of the data.
Data synthesis
Data from the selected studies will be compared using the Cochrane Collaboration's statistical software, Review Manager (Review Manager 2011). If studies are sufficiently similar, a meta‐analysis will be undertaken. If meta‐analyses are performed, the random effects model will be used.
When the same outcome measures are assessed with different scales, standardised mean differences (SMDs) will be used.
However, it is anticipated that data from different studies will be difficult to compare, such that a meta‐analysis may be inappropriate. This is particularly the case for the main outcome "recurrence", because of:
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differences in length of follow‐up (the recurrence rate increases with length of follow‐up); and
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differences in the definition of "recurrence" between different papers.
We will use fixed‐effect model to combine data if outcomes are homogeneous. If the results are heterogeneous, we will undertake subgroup analysis to identify the reasons of heterogeneity. The random‐effects model will be applied if we cannot find any reason for heterogeneity.
If the nature of the included studies do not allow for statistical analysis, narrative (qualitative) summaries will be used to present the results.
Subgroup analysis and investigation of heterogeneity
If significant heterogeneity is found, the data will not be pooled and a summary of methodological quality and results will be presented. Reasons for heterogeneity will be considered using subgroup analysis. Subgroup analysis will be considered with regard to:
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length of time to follow‐up;
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proximal interphalangeal joint and metacarpophalangeal joint outcomes separately as it is well recognised that metacarpophalangeal joint contractures correct better than proximal interphalangeal joint contractures;
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severity of disease prior to operation. Where provided, it is expected that this will be in the form of total passive extension deficit (i.e. the sum of the passive extension deficit at the metacarpophalangeal and proximal interphalangeal joints);
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number of joints involved;
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postoperative treatment offered.
Sensitivity analysis
Outcome measures, e.g. the definition of recurrence, have been defined differently (Becker 2010). A sensitivity analysis to examine whether the result varies according to different definitions.
We will also undertake sensitivity analysis for missing data, for example intention to treat versus per protocol analysis, to examine variations between different analysis approaches.
