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British Medical Bulletin Advance Access originally published online on September 26, 2008
British Medical Bulletin 2008 88(1):171-188; doi:10.1093/bmb/ldn036
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© The Authors 2008. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org

Operative management of tennis elbow: a quantitative review

Salil Karkhanis{dagger}, Andrew Frost{ddagger} and Nicola Maffulli*,¶

{dagger} Department of Trauma and Orthopaedics, Tameside General Hospital, Ashton under Lyne
{ddagger} Department of Trauma and Orthopaedics, Staffordshire General Hospital, Stafford
Department of Trauma and Orthopaedic Surgery, Keele University School of Medicine, Thornburrow Drive, Hartshill, Stoke on Trent, Staffordshire ST4 7QB, UK

* Correspondence to: N. Maffulli, Department of Trauma and Orthopaedic Surgery, Keele University School of Medicine, Thornburrow Drive, Hartshill, Stoke on Trent ST4 7QB Staffs, UK. E-mail: osa14{at}keele.ac.uk


   Abstract
Top
 Abstract
Introduction
 Materials and methods
 Results
 Discussion
 Conclusion
 References
 
Introduction: The results of operative management of tennis elbow are varied, and the indications for surgery are not well codified. Many operative techniques are reported, but a clear consensus on whether a given surgical procedure is more effective over another is yet to be reached.

Methods: We conducted a MEDLINE, CINAHL and EMBASE search on all available scientific articles that reported the outcomes of surgery for lateral epicondylopathy. Keywords used were ‘tennis elbow’, ‘lateral epicondylitis’, ‘lateral epicondylalgia’, ‘tendinopathy’, ‘tendonitis’ and ‘tendon’. Subheadings used were ‘surgery’, ‘outcomes’, ‘pathology’, ‘physiology’ and ‘operation’. All relevant articles were retrieved. Each article was scored using the Coleman methodology score (CMS), a highly repeatable methodology score, by two independent reviewers, followed by data analysis.

Results: The mean CMS for the 45 studies identified was 43 ± 9 (of a possible 100 points), with ‘number of patients’, ‘type of study’, ‘outcome criteria and assessment’ and ‘subject selection process’ being the major low scorers. Also, there was no improvement in the CMS, and hence study design, over the years (intra-class correlation coefficient = 0.45).

Discussion: There is a dearth of quality evidence available to be able to advocate one operative technique over another.

Conclusion: We stress the need for well-designed adequately powered randomized controlled trials to be able to understand which of these operative techniques is really superior to the others.

Keywords: tennis elbow • lateral epicondylitis • Coleman • operation


   Introduction
Top
 Abstract
 Introduction
Materials and methods
 Results
 Discussion
 Conclusion
 References
 
Tennis elbow (TE) is commonly diagnosed in patients with pain over the lateral aspect of the elbow, worsened or aggravated by repetitive or excessive movements of wrist, with the elbow in extension. Patients are tender over the lateral epicondyle, and resisted wrist extension worsens the pain. TE is more prevalent in patients in their fourth and fifth decade, with no gender preference, and involves the dominant elbow in 70% of patients.1

Recently, the non-inflammatory nature of tendinopathy has been stressed,2,3 and it has become clear that TE does not involve an inflammatory process of the common extensor origin (CEO). Kraushaar and Nirschl4 proposed that the pathology is angiofibroblastic hyperplasia of the CEO, especially of the tendon of the extensor carpi radialis brevis (ECRB), in line with the other overuse tendinopathies.5 While direct comparative studies have not been performed, the histology in upper limb tendinopathy does not appear to be dissimilar from that of lower limb tendinopathy.6–8 We have adhered to this paradigm in the present study.

Intra-articular pathologies, such as chondromalacia of radiocapitellar joint,9 synovial fringe impingement,10 involvement of the annular ligament,11 have also been implicated, as have, either on their own or in conjunction with tendinopathy, compression and/or entrapment of the radial nerve or the anterior cutaneous nerve,12 traumatic periostitis of ECRB,13 and radiohumeral bursitis.14

The diagnosis of TE is mainly clinical, with imaging modalities such as ultrasound and MRI, to be used only for confirmatory, not diagnostic, purposes.15

The initial management of TE is conservative, with the use of rest, activity modification, Non- steroidal anti- inflammatory drugs, forearm bracing,16 physiotherapy and local steroid injections.17 These measures result in at least a transient remission in up to 90% of patients, and 3–8% of patients, who are refractory to conservative treatment, may be surgical candidates.18

Operative management of TE still remains the centre of debate. Since 1922, 14 main surgical treatments modalities, with some 300 modifications, have been described.10 However, we still do not know whether a given surgical procedure is to be preferred, why each of the different modifications of surgery reports such high success rates, and why some patients fail to respond to surgery. We believe that the answer lay in the methodology applied in each of these studies. Therefore, we performed a quantitative review on the operative management of TE to try and answer these issues, with a reliable, validated scoring system at the centre of this study.


   Materials and methods
Top
 Abstract
 Introduction
 Materials and methods
Results
 Discussion
 Conclusion
 References
 
We conducted a MEDLINE, CINAHL and EMBASE-based search on all available published articles that reported the outcomes of surgery for lateral epicondylopathy. Keywords used were ‘tennis elbow’, ‘lateral epicondylitis’, ‘lateral epicondylalgia’, ‘tendinopathy’, ‘tendonitis’ and ‘tendon’. Subheadings used were ‘surgery’, ‘outcomes’, ‘pathology’, ‘physiology’ and ‘operation’. All journals were considered, and all relevant articles retrieved. The search was limited to the English language or articles with available English translations. Case reports, literature reviews, letters to editors and articles not reporting outcomes were excluded from our study. The references section of each article retrieved were hand searched by two authors (SK and AF) to identify further studies.

All studies included in the present investigation were evaluated on the basis of surgical technique, reported outcomes and complications, and methodological design, and the results classified accordingly. Any outcome measure adopted in the studies included in the present investigation assessed three basic fields, namely pain, elbow function and patient satisfaction. Similar grading systems, with minor changes, were used by Nirschl and Pettrone19 Grunbderg and Dobson20 and Verhaar et al.21 Most scientific articles graded results as ‘excellent’, ‘good’, ‘fair’ and ‘poor’. Success rate was defined as the sum of ‘excellent’ and ‘good’ outcomes expressed as a percentage of total outcomes. Consequently, failure rate was defined as ‘fair’ or ‘poor’ outcomes expressed as a percentage of total outcomes. We also reviewed the articles for reported complications and classified the results.

For methodological assessment, we scored each scientific article using the 10 criteria of the Coleman methodology score (CMS) system22–25 (Table 1). The Coleman scoring system is a method of analysing the quality of the studies reviewed, and it is accurate and reproducible in systematic reviews and has been used successfully for several years. In addition, it has been validated out with our research centre.26


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  		Table 1 Coleman methodology score

 
The CMS can range between 0 and 100, with a perfect score of 100 indicating a study that was well designed and avoided the influence of bias, confounding factors and chance. Each article was scored independently by two authors (SK and AF), and the average value was considered as the score of the relevant scientific article.

Regression analysis was used to assess the extent of agreement between the Coleman scores of the two independent assessors and the intra-class correlation coefficient score was calculated. The same method was used to assess correlation between the year of publication and the Coleman score. Analysis was performed using SPSS software (version 16.0, Chicago, IL, USA).


   Results
Top
 Abstract
 Introduction
 Materials and methods
 Results
Discussion
 Conclusion
 References
 
We identified 45 published studies from 1953 to 2006, which reported surgical outcome rates for TE, and reviewed them as part of our study (Table 2).


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  		Table 2 List of articles with level of evidence, number of elbows (N), follow-up (months), average CMS and reported outcomes (surgical success rate or other documented results)

 
Pre-operative features

Most of the patients included in the studies were within the specified age group (third to fifth decade), have had their symptoms for an average of 19 months (6–132 months). The dominant arm was involved in an average of 74% of cases.

Age and follow-up

The number of patients (elbows) included varied from 327 to 125.28 The mean follow-up time also fluctuated from 1229,30 to 96 months31,32 (Table 2).

Study type

Only three of the studies were randomized controlled trials,29,33,34 four were prospective cohort studies,21,35–37 and 38 were retrospective studies, of which six were retrospective comparative studies19,20,31,38–40 (comparing two or more operative techniques).

Type of procedure

Given the variety of surgical procedures described, we categorized the different surgical techniques into three broad groups: open, percutaneous and endoscopic. Table 3 lists the articles, under these headings, describing any one of them exclusively. Comparative studies and randomized control trials are listed as a separate group.


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  		Table 3 List of articles according to type of approach. Comparative studies have been grouped separately

 
Surgical description and post-operative rehabilitation

Most of the studies concentrated on one operative technique only, with an ‘adequate’ to ‘fair’ description of the process. The description of post-operative rehabilitation in one-third (15/45) of the studies was inadequate according to CMS.

Subject selection, outcome criteria and outcome assessment

Around 87% (39/45) of the studies reported an unsatisfactory description of subject selection criteria with only one scientific article scoring 15/15.21 The articles showed a wide variation in outcome criteria used, and scored poorly in this section with only one article scoring 15/15.37 The main reason for this was poor description of outcome criteria and use of non-validated scoring systems with poor reliability and sensitivity. Most studies failed to mention the ‘timing’ of measuring outcome criteria. The ‘outcome assessment’ section scored poorly in 38% (17/45) of the articles. In the rest of the published articles, this process was flawed from the lack of one or more of the four criteria mentioned in the CMS. In all but three scientific articles,10,37,40 outcomes were assessed by the surgical team itself, introducing a major source of bias.

CMS and statistical results

The means of the CMS for each section are listed in Table 4: the average CMS score was 43 ± 9 (range 20–85). Mean CMS of individual scientific articles are listed in Table 2.


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  		Table 4 Mean of calculated CMS and total score (number of scientific articles = 45)

 
The intra-class correlation coefficient gave a score of 0.98. This indicates a high correlation between the CMS awarded to each scientific article by each independent marker. Comparing the CMS with year of publication gave an intra-class correlation coefficient score of 0.45. This indicates that the more recent scientific articles were not significantly better than the older studies.

Reported outcomes and complications

Almost all the articles have used different methods of reporting their results. However, most scientific articles reported results according to the aforementioned classification (Table 2). While these articles cannot be directly compared, the surgical success rates for the open technique have been reported to be between 1941 and 100%27 (mean 80.4%). The percutaneous technique has reported success rates of 8042–96%43 (mean 89.5%), and the endoscopic technique has success rates of 9310 to 100%44 (mean 96%).

In a situation where surgical success rates are not conclusive, one relies on an approach that has the least morbidity or complication and failure rate, and early return to work. The open approach had a reported mean failure rate of 11.4% (031–81%41), with a reported mean complication rate of 10.6% (041–33%27). Commonly reported complications were wound haematoma (2), wound infection/abscess (7), scar disturbance (2), chronic pain (1), stiffness (5) and neurological problems (3). The mean time to return to work (pre-injury) was 6.6 weeks (2.619–20 weeks45). The average CMS was 42.3.

The percutaneous approach reported a mean failure rate of 8.7% (3.843–12.7%42), with a reported complication rate of 6.3%20. There were two reported wound haematomas with time to pain relief of 8.5 weeks (843–9 weeks20). Average CMS of the scientific articles was 44.3.

The reported average failure rate of the endoscopic approach was 8.3% (6.610–1046), with no reported complications. The average time to return to work was 9.6 days (644–16 days46). The average CMS of the four scientific articles in the endoscopic group was 43.5.


   Discussion
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
Conclusion
 References
 
Usually, patients undergoing operative management for TE have been resistant to a prolonged period of conservative management, or have had previous successful operations on their other elbow. The pathology can be approached by open, percutaneous and endoscopic routes. The open approach still remains the most common of the three, but there has been a recent increase in reports on percutaneous and endoscopic approaches.

There were a variety of confounding factors within each study that made their statistical comparison challenging. The articles included in the present study used different methodologies, which account for a wide fluctuation in the CMS recorded. Also, while analysing data for the present study we came across many studies detailing level 4 evidence. While we acknowledge that evidence from these studies can be fraught with bias, we do believe that pooling data or comparing data from these studies can help us come up with clinically relevant conclusions. This point was supported by data from other systematic reviews on the same topic.47

A common finding during the present study was the variable but high success rate of virtually all types of surgical procedures for TE, coupled with a relatively low reported complication/failure rate. The 2002 Cochrane Database Review failed to provide any definite conclusions. This raises the question – If one procedure is so successful, why do we need to resort to such a wide variety of techniques? We believe that this multiplicity of techniques stems from the relatively widespread lack of the aetio-pathogenesis for this condition. Also, the large number of reported modifications to each surgical technique shows a constant attempt by surgeons to improve surgical success rates, reduce complications, and make the procedure less technically demanding. Lack of satisfaction with one surgical technique stems from gross discrepancies between reported surgical success rates and personal clinical experiences.

Open approach

The open approach has seen a variety of procedures based on releasing, lengthening, excising and repairing the CEO, with occasional focus on the elbow joint to look for any obvious pathology. The open approach allows good visualization of the operative field, and allows dealing with concomitant pathologies in the elbow.19,21 However, it is associated with increased failure rates and complications.19,35 Also, it produces increased time to return to pre-injury level of activity.29

A consistent finding was the difference in operating principles followed in different regions of the world. Most open procedures reported from Europe relied on the ‘release’ of the CEO. We identified eight such scientific articles.21,28,48–53 On the other hand, centres in North America (and some in Europe) reported the more widely accepted Nirschl technique of excision of the damaged CEO origin or its variations. Six such scientific articles were identified as well.34,45,54–57. While all techniques have a convincing rationale, the one behind Nirschl's technique, i.e. excision of the area of angiofibroblastic hyperplasia,4 seems to be the current standard. Investigations reporting release of CEO have success rates between 5048 and 92%51 (mean = 81.6%). The six scientific articles studies reporting the results of the excision of the damaged CEO origin had success rates between 7958 and 85%19 (mean = 82%). Also, failure rates for the release procedure varied from 050 to 24%28 (mean = 8.6%). Similarly, reported failure rates of the excision of the damaged CEO origin ranged from 2.319 to 19%45 (mean = 5.2%). Methodologically, scientific articles reporting the Nirschl technique had an average CMS of 46, while the average CMS for scientific articles reporting the release technique was 42.6. Individually, the seminal scientific article by Nirschl and Pettrone19 itself scored a poor 51 on the CMS, with ‘type of study’, ‘outcome criteria’, ‘outcome assessment’ and ‘subject selection criteria’ accounting for relatively low scores. Similar low scores were found in all studies in either of the groups. While it does not nullify the findings of these scientific articles, it does acknowledge the bias associated with these findings.

Also, it has recently become apparent that successful management of tendinopathy does not relate to excision of the actual tendinopathic lesion.59–61

Percutaneous approach

Compared with the open approach, the percutaneous technique had a lower complication rate.20,42,43,62 A prospective study by Dunkow et al.29 (CMS = 52) showed the percutaneous technique to be more successful than the open technique in terms of DASH (disability of arm, shoulder and hand score) score and earlier return to activity. It can be performed as an office procedure, although it may not directly address the actual pathology of TE. Nevertheless, the same could be said of several open techniques.

Endoscopic approach

The endoscopic technique allows to visualize the joint, and the pathology of the ECRB, and to deal with concomitant pathologies. However, it is a longer,63 technically more demanding operation. The endoscopic technique showed similar success rates as reported in scientific articles discussing open techniques, but appeared to report a lower failure rate10,46 and an earlier return to activity.10,44,46 Peart et al.64 who reported return to work in the open group at 10 weeks and 6.8 weeks in the endoscopic group, did not support the view as their findings were not statistically significant. Three scientific articles38,39,64 reported a comparative study between the open and endoscopic technique. None of the scientific articles were able to report a significant difference in the reported success rates of the open and endoscopic techniques.38,64 The only reported complications in the scientific articles were in the endoscopic group (post-operative haematoma, wound infection).38,64

Our study also shows a generalized inadequacy in the methodological design of the studies that report these outcomes. These inadequacies (confounding factors/biases) consequently reflect on the reported outcomes and surgical success rates. Moreover, it is also evident that there has been no improvement in CMS or the quality of our study designs over many years. It is therefore imperative that attempts be made to design studies on surgical outcomes of TE of a much stronger and uniform design. However, there is also a need to critically evaluate all scientific reports regardless of study design or level of evidence, so as not to confer undue merit on a report.65 It also brings to light the need to have a robust method of evaluating these studies to validate or reject their reported outcomes.

Common problems in methodology and suggested solutions

We identified seven key areas of major methodological deficiencies, namely:

Type of study
 Ideally, a meta-analysis of randomized, controlled trials would provide us with the best possible evidence on this topic. However, while conducting our study, we noticed a dearth in published prospective cohort/randomized controlled studies. Most of the published literature comprised retrospective studies or case series.

Through prospective studies we are able to avoid selection and investigator bias through rigid selection criteria, well documented pre-operative examination findings and regular post-operative assessments. Higher degree of validation is achieved if the studies are ‘double or triple blinded’. However, difficulty may be encountered in acquiring ethical committee's approval and appropriate funding, and dealing with the issue of attrition bias. In our clinical setting, grassroot work is performed by junior doctors, who, as part of their training, quickly rotate out of their jobs. Senior clinicians therefore find it difficult to find dedicated staff to work on these studies. Prospective studies are generally avoided due to their time consuming nature and prolonged follow-up. We must endeavour to design future studies prospectively.

Retrospective studies provide the weakest form of evidence yet they were the commonest studies found. Selection bias is quite common. There might not be adequate pre- operative examination details and most of them tend to be database analyses. They are carried out a few years after the actual procedure which brings in the element of recall bias. Valuable information can still be obtained from these studies, provided they are appropriately designed to minimize the confounding factors.

Number of patients
 It is advisable to use a larger number of patients so that the findings will be a better representation of the population. The average number of patients in our review was 36 (3–125). Several of the studies analysed had very low patient numbers (or elbows), some with only three patients. Sample size calculation, based on a power analysis, should be included in the design of a trial. Since there is little agreement amongst surgeons on what the outcome measure should be used, given the multiplicity of outcome assessment tools available to evaluate elbow procedures, sample size calculations remains a point of debate. In any case, such a study would probably require large numbers of patients. Loss to follow up after recruitment and attrition are common in such trials. Considering these aspects, the number of patients required to perform such trials should, therefore, be extremely high. It is unlikely that such a trial will ever be performed, and we suspect that trials involving much smaller number of patients will instead be performed. To cite an example of the randomized study by Dunkow et al.,29 one can estimate a power analysis using the difference of 3 between the improvement in basic DASH scores of the open and percutaneous group. One would need ~64 patients in each group (using a simple two sample t-test with a standard deviation of 6) with the conventional 5% level of significance. It is worth noting that the sample size appear larger than those used in the study, probably due, in part, to the approximation to the standard deviation required. Also, studies would have to span longer periods to allow for more patients to be included.

Subject selection criteria
 This is the point where every attempt is made to avoid selection bias, which could be investigator controlled or patient controlled. A large number of studies in the present investigation had an inadequate description of the subject selection criteria. A prospective study eliminates this possibility by having pre-determined strict selection criteria. In a retrospective study a clear indication should be made of the proportion of total patients that were available for follow-up to be able to interpret outcomes in the right perspective.

Description of surgical procedure
 To be able to understand a given surgical procedure, authors should make every attempt to describe the technique in totality. Some of the articles in the study had an inadequate description of the surgical technique, which makes it difficult for surgeons who read the article to reproduce them.

Description of post-operative rehabilitation
 Around 33% of the studies in our review had an inadequate description of post-operative rehabilitation process. Description of post-operative rehabilitation gives an idea of the expected time frame for recovery of function. Since no evidence-based standardized post-operative rehabilitation regimes have been documented there existed a gross variability in post-operative rehabilitation protocols and absence of any documented patient compliance rate. Most surgeons will rely on personal experiences and patient's factors to plan their rehabilitation regimes. Prospective studies should be able to give adequate descriptions of post-operative rehabilitation protocols, as well as, report compliance rates.

Outcome criteria used
 Most of the studies scored poorly in this section of the CMS. The timing of outcome assessment was not stated in most studies. Due to the lack of evidence- based standardized outcome criteria, clinicians have to rely on tried and tested outcome assessments tools, or modify them to suit their study. Most subjective assessment criteria focussed on patient perception of pain, return of elbow function and patient satisfaction. A very basic scoring system is the Visual analogue score.66 The Nirschl pain phase score66 is a more detailed assessment tool. Similarly, the Mayo clinic elbow evaluation,67 the Roles and Maudley68 score and the DASH (American Academy of Orthopaedic Surgeons) are other assessment tools. Objective criteria reported clinical evaluation of the operation wound, measurement of range of movement of elbow, and grip strength measurement using a dynamometer. The outcome criteria used depends on a variety of factors, and the scoring system used has to be tapered to suit the study. Longo et al.69 published a systematic review on the rating systems for evaluation of the elbow, which could be helpful in selecting the appropriate rating system.

Assessment of outcome
 The value of the outcome assessment is greater if conducted in prospectively recruited subjects, rather than relying on retrospective recall or on examination of notes. The latter are more prone to recall bias. The medium of conducting the assessment also makes a difference to the actual outcome. A face-to-face conversation is likely to generate a more reliable response than a telephonic interview. However, the patient may give a favourable response rather than the right response, when interviewed by a member of the surgical team. Therefore it is imperative that the assessment be carried out by an independent investigator and written responses must be carried out with minimal investigator involvement. Also written responses provide a reference for follow-ups/future studies.


   Conclusion
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Conclusion
References
 
There is insufficient evidence to support the use of one operative procedure for TE over another. In TE, no standard surgical treatment exists: it is vital that we interpret published outcomes accurately. Unfortunately, the surgical outcomes being published are from studies with gross methodological deficiencies. Our statistical results show that there has not been any significant improvement in study designs over the years. Clinicians should attempt to improve study methodology. Greater attention to issues raised and adherence to recommendations of this review would help in achieving the same.

Accepted for publication September 2, 2008.


   References
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Conclusion
 References
 

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