Evidence-based and Patient-centered Indication for Knee Arthroplasty – Update of the Guideline

• Abstract
• Introduction
• Methodology
• Results
• Guideline recommendations
• Structural damage
• Knee pain
• Inadequate guideline-appropriate non-surgical therapy
• Reduction in health-related quality of life and subjective level of suffering
• Contraindications
• Optimisation of modifiable risk factors
• Additional risk factors
• Shared decision-making
• References

Abstract

Background

Knee arthroplasty is one of the most frequently performed operations in Germany, with approximately 170000 procedures per year. It is therefore essential that physicians should adhere to an appropriate, and patient-centered indication process. The updated guideline indication criteria for knee arthroplasty (EKIT-Knee) contain recommendations, which are based on current evidence and agreed upon by a broad consensus panel. For practical use, the checklist has also been updated.

Methods

For this guideline update, a systematic literature research was conducted in order to analyse (inter-)national guidelines and systematic reviews focusing on osteoarthritis of the knee and knee arthroplasty, to answer clinically relevant questions on diagnostic, predictors of outcome, risk factors and contraindications.

Results

Knee arthroplasty should solely be performed in patients with radiologically proven moderate or severe osteoarthritis of the knee (Kellgren-Lawrence grade 3 or 4), after previous non-surgical treatment for at least three months, in patients with high subjective burden with regard to knee-related complaints and after exclusion of possible contraindications (infection, comorbidities, BMI ≥ 40 kg/m²). Modifiable risk factors (such as smoking, diabetes mellitus, anaemia) should be addressed and optimised in advance. After meeting current guideline indications, a shared decision-making process between patients and surgeons is recommended, in order to maintain high quality surgical management of patients with osteoarthritis of the knee.

Conclusions

The update of the S2k-guideline was expanded to include unicondylar knee arthroplasty, the preoperative optimisation of modifiable risk factors was added and the main indication criteria were specified.

Introduction

Knee arthroplasty is one of the most common operations in Germany, with around 170000 procedures carried out in 2021 [1]. In Germany, 87% of procedures are total knee arthroplasties (TKA) and 13% are unicondylar knee arthroplasties (UKA) [2].

There are several conservative and surgical treatment options to treat osteoarthritis of the knee which can be used depending on the stage of disease [3]. In the early stages, the focus must be on educating the patient, lifestyle adaptations, supervised exercises, and weight loss. It is also important to investigate whether reconstructive procedures (e.g., osteotomy) could be an option. If the symptoms progress, treatment can consist of medication (especially topical and systemic non-steroidal anti-inflammatory drugs [NSAIDs] after all contraindications have been taken into account) and non-medical therapies (e.g., physiotherapy, walking aids). A recently published network meta-analysis which was based on a large number of cases (152 randomised studies [RCT], n = 17431 patients with hip or knee osteoarthritis) showed that supervised exercises achieved results which were equivalent in terms of pain relief and functional improvement within 6 months to those obtained with NSAIDs/paracetamol [4]. Based on these findings, supervised exercises should be given a high priority in non-surgical therapy, particularly considering the potential side effects of taking medication which can never be totally excluded.

For patients with moderate or severe osteoarthritis of the knee and symptoms that cannot be relieved sufficiently with non-surgical therapy, knee arthroplasty is one of the most successful and effective treatment options [5] [6] [7]. The patient-related results reported in the National Joint Registry (NJR) demonstrate that 95% of patients experience an improvement with regards to knee pain and function (by an average of 17 points on the Oxford Knee Score) [8]. According to a meta-analysis published in 2019, the expected durability of a TKA is 93.0% after 15 years, 90.1% after 20 years and 82.3% after 25 years [9]. Moreover, the rate of surgery-related complications necessitating a longer stay in hospital (1.26% for general complications and 0.97% for specific complications) and the mortality risk (0.04%) are extremely low [10].

In Germany, the incidence of knee arthroplasty varies according to region and can differ between individual federal states by a factor of up to 3.2, with higher numbers of procedures reported for South Germany [11]. It has been suggested that the reason for this variation has been the lack of standardised decision criteria which would ensure that the indications for knee arthroplasty are transparent and consistent [11]. This prompted specialists to launch the guideline project “Evidence- and Consensus-based Indication Criteria for Knee Arthroplasty (EKIT-Knee)” under the aegis of the German Society for Orthopaedics and Trauma Surgery (DGOU) and the German Arthroplasty Society (AE) [12], which led to a guideline being developed. This guideline has now been updated [7]. The aim of the update was to review recommendations based on current evidence and bring them into line with the existing S3-guideline “Evidence- and Consensus-based Indication Criteria for Total Hip Arthroplasty for Coxarthrosis (EKIT-Hip)” [13].

Methodology

Sixteen representatives from 14 professional societies/organisations and 4 patient representatives were involved in updating the guideline ([Table 1]). In addition to the systematic search for (inter-)national guidelines and systematic reviews/meta-analyses carried out for the S3-guideline EKIT-Hip (which focused on patients with osteoarthritis/total hip or knee replacement or gonarthrosis/knee arthroplasty), an update was carried out for the search period 2018–2023 using the keywords “osteoarthritis of the knee” and “knee arthroplasty or replacement” for the topics “risk factors” and “association between radiological severity and outcome after knee arthroplasty”. Based on the identified evidence, documents were compiled for participants to vote on and sent to the members of the guideline group for their comments 6 weeks prior to the consensus conference.

Results

The following amendments and additions were agreed upon:

1. The scope of the guideline application was expanded to explicitly include unicondylar knee arthroplasty.

2. The main criteria were subdivided into objective and subjective criteria.

   • The objective criterion “structural damage” was expanded by the addition of a further recommendation that surgery is indicated in cases with moderate or severe osteoarthritis (Kellgren-Lawrence grade 3 or 4 disease or more) or deformations/defects of the joint surface caused by osteonecrosis.

   • The subjective criteria were amended by the addition of a recommendation on the collection of information about patients’ level of suffering based on the use of validated instruments for patient-reported outcomes.

3. Risk factors: modifiable risk factors with separate recommendations on preventive measures prior to knee arthroplasty have now also been included and are: diabetes mellitus, BMI ≥ 30 kg/m², smoking, anaemia, intraarticular injection of glucocorticoids, suspicion of insufficiently treated psychological disorder, and active inflammatory rheumatic disease.

4. Shared decision-making (SDM): the recommendation on SDM was amended to include asking patients about their individual treatment goals prior to having knee arthroplasty; these goals must then be discussed with regards to their feasibility and documented.

Guideline recommendations

The following five main criteria must be met for indication of a knee arthroplasty: structural damage, knee pain, insufficient conservative therapy, reduced quality of life, and subjective psychological stress.

Structural damage

Structural damage is present if X-ray imaging shows Kellgren-Lawrence grade 3 (moderate) or 4 (severe) osteoarthritis or if osteonecrosis has resulted in deformation or a defect of the joint surface. A posterior-anterior (PA) weightbearing radiograph of the knee (Rosenberg view) is recommended as this permits better assessment of the loss of joint space in the posterior femoral subregions, especially in cases with valgus osteoarthritis.

As this procedure is irreversible and because of the potential risks associated with the procedure, surgery is usually only indicated for cases with moderate or severe osteoarthritis. Two recent meta-analyses have shown that a significantly higher pre-/postoperative improvement of pain, knee function and satisfaction is achieved in cases with moderate or severe ostearthritis compared to mild osteoarthritis (n = 8542 knee arthroplasties) [14] and that surgery for mild or moderate gonarthrosis was associated significantly more often with chronic pain and dissatisfaction (n = 12723 knee arthroplasties) [15]. Nevertheless, there are some borderline cases where, despite radiological imaging showing a less severe level of osteoarthritis, the full extent of cartilage damage (full-thickness damage) is only visible on MRI and knee arthroplasty is indicated. Additional imaging using MRI must only be done if there are discrepancies between the clinical and the radiological findings. This also applies to osteonecrosis, where knee arthroplasty may be indicated even if there are no signs of advanced osteoarthritis. MRI is particularly useful to show extensive full-thickness cartilage damage and the extent of osteonecrosis or to assess whether bone marrow oedema could be present.

Knee pain

Many patients with advanced osteoarthritis report knee pain. Medication is usually very effective to treat short-term pain. If the knee pain cannot be improved by guideline-appropriate non-surgical therapy [16] administered over a period of at least 3 months, it can be asssumed that further non-surgical therapy measures will also not be able to improve symptoms. Patients may then be offered knee arthroplasty. Almost all patients report pain prior to knee arthroplasty and pain is also an important criterion for the decision to have surgery [17]. Almost all patients expect that knee arthroplasty will result in pain relief and for most patients, this expectation is fulfilled or even exceeded [18].

Inadequate guideline-appropriate non-surgical therapy

The recommendation that non-surgical treatment of patients with osteoarthritis should consist of a combination of medication-based and non-medication-based therapeutic measures is based on a broad international consensus [6] [19] [20] [21]. Patients must have received or been offered the following non-medication-based measures:

• Patient education (information, education, and counselling about the disease)

• Exercise therapy and promotion of physical activity

• Weight loss for patients who are overweight or obese

The evidence base for the 2 first two measures is extensive and of high quality. Disease-specific information (therapy programmes, self-management programmes, tutorials, booklets) significantly affects pain relief, reduces pain medication, and improves quality of life and self-help [20]. The guideline of the Osteoarthritis Research Society International (OARSI) reported on 8 RCTs which showed that exercise therapy had a significant impact on pain relief, functional improvement, and activity levels [6].

If there is insufficient improvement despite carrying out guideline-appropriate non-surgical therapeutic measures for at least 3 months and a high subjective level of suffering persists, knee arthroplasty is indicated. An analysis of 77 RCTs (comparison of an intervention group which received additional exercise therapy with a control group which did not receive additional therapy) by Goh et al. [22] demonstrated that the positive effects with regards to pain relief, improved function and activity, and improved quality of life following additional exercise therapy peaked after 8 weeks and began to decrease thereafter. After about 9–18 months no differences could be found between the intervention group and the control group. It can therefore be assumed that if guideline-appropriate conservative therapy does not result in sufficient improvement within 3 months, an improvement will not occur later on either.

Reduction in health-related quality of life and subjective level of suffering

After assessing the severity of osteoarthritis both clinically and radiologically, the adverse effects and the level of suffering caused by the osteoarthritis must also be evaluated. In addition to pain, this includes functional limitations, adverse effects on activities of daily living and a reduced health-related quality of life [19] [23] [24].

The collection of this data is not just relevant when evaluating treatment outcomes but also important when making shared decisions for or against knee arthroplasty. It is important to do this by using validated instruments for patient-reported outcome measures (PROMs). The AE has published consensus-based recommendations on measuring outcomes after hip and knee arthroplasty procedures [24]. Although the recommendation to use the Oxford Knee Score (OKS) or alternative instruments to measure outcomes (WOMAC, KOOS or KOOS-PS) along with the use of a generic score (e.g., EQ-5D, SF-12, SF-36) was primarily aimed at clinical studies, the recommendation can also be expanded to cover the use of such scores in general practice. The above-listed PROMs are also available in German [24].

Ultimately, the indication for knee arthroplasty must be based on a high level of suffering with knee-related complaints (pain, functional limitations, restrictions with regards to activities of daily living) and a reduced health-related quality of life combined with the presence of other indication criteria (Kellgren-Lawrence grade 3 or 4 osteoarthritis, guideline-appropriate conservative therapy for at least 3 months without sufficient improvement) [7] [20].

If not all of the main criteria are met, subsidiary criteria can also be used to confirm the indication for knee arthroplasty. Pronounced misalignment or instability due to destruction of the joint despite limited pain can be an indication that joint replacement is required. This must be reviewed on a case-by-case basis and the findings recorded.

Contraindications

The number of patients for whom knee arthroplasty is absolutely contraindicated is relatively small. Because of the increased risk of infection, revision, and mortality, knee arthroplasty is not indicated or should be critically reviewed if the following factors are present:

Absolute contraindications:

• Active, not fully healed infection

• Acute or chronic comorbidities which constitute a contraindication for elective surgery (e.g. acute cardiovascular event)

Relative contraindications:

• Significantly reduced life expectancy due to comorbidities (in such cases, the benefits and risks of surgery must be weighed up particularly carefully)

• Morbid obesity (BMI ≥ 40 kg/m²)

While most contraindications are undisputed, the inclusion of morbid obesity is regularly discussed. The association between BMI ≥ 40 kg/m² and a significantly increased risk of periprosthetic infections is not in doubt [25] [26]. The association between higher BMI and arthroplasty failure has also been clearly proven in the German Arthroplasty Registry (EPRD) [2]. However, when patients have a BMI ≥ 40 kg/m², then achieving a relevant weight loss is very difficult. To what extent weight loss, for example achieved with the help of bariatric surgery, ultimately reduces the risk of knee arthroplasty is currently not known. It is therefore important to be especially critical when weighing up the benefits against the risks of arthroplasty in these patients. The recommendation is that in all such cases, the patient should see an obesity outpatient clinic. It is also important to be aware that with these patients, implantation of an arthroplasty could constitute an off-label use, i.e., the implant is being using outside its approved use, as the instructions for use (IFU) for different knee arthroplasty systems cite obesity or morbid obesity as contraindications. If necessary, patients must be informed about this off-label use [27]. As the functional gains and the satisfaction with the arthroplasty are comparable for obese and normal-weight patients, it seems to be ethically indefensible to generally exclude these patients from knee arthroplasty despite the higher risks involved [28] [29] [30].

Optimisation of modifiable risk factors

Patients have individual risk factors which can negatively affect the perioperative and postoperative complication rates as well as treatment outcomes and the revision rates [2] [31]. When planning surgery, it is important to know whether existing risk factors can be modified and individual risk of complications reduced. Modifiable risk factors include uncontrolled diabetes mellitus, obesity, smoking, anaemia, intraarticular injection of glucocorticoids, mental disorders, and active inflammatory rheumatic disease.

• When treating patients with diabetes mellitus, blood glucose levels must be optimally controlled prior to knee arthroplasty. The aim should be to achieve an HbA_1c of less than 8%.

• If the patient has a BMI of ≥ 30 kg/m², the patient should be advised to lose weight.

• Smokers must be advised to stop smoking at least 1 month prior to the planned surgical procedure.

• A diagnostic workup to check for anaemia should be done prior to knee arthroplasty and treatment should be initiated for patients with anaemia requiring treatment.

• Following intraarticular injection of glucocorticoids, surgery can be carried out after 6 weeks at the earliest; the recommended interval between injection and surgery should be 3 months.

• If there is a suspicion that the patient has a mental disorder which has not been adequately treated, the patient should be advised to have a consultation with a mental health specialist prior to knee arthroplasty.

• Active inflammatory rheumatic disease must be adequately controlled using medication prior to knee arthroplasty. If glucocorticoids are required at the time of surgery, the target must be a glucocorticoid dose of not more than 7.5 mg prednisolone per day.

The evidence for the respective recommendations is presented in the guideline [7].

Additional risk factors

There are additional risk factors which are associated with a higher complications profile or poorer patient-relevant outcomes. Many of these risk factors cannot be optimised. The following risk factors must be taken into consideration and discussed with the patient when making the indication foor knee arthroplasty:

• Prior infection of the knee joint

• Increased risk of infection

• Higher perioperative risk (ASA 3 and 4)

• Other physical or psychological comorbidities or medications which increase the surgical risk

• Substance addiction or abuse (including nicotine, alcohol)

• Unrealistic expectations from the patient

Shared decision-making

Shared decision-making improves the outcome after knee arthroplasty [32], but it is not yet part of general clinical practice [33]. Fulfilling patients’ expectations on knee arthroplasty is an essential factor for patient satisfaction [18] [34]. For this reason, identifying and recording the individual patient’s expectations and goals is an important part of shared decision-making as is the subsequent discussion about whether knee arthroplasty can meet the patient’s expectations. The discussion should include expected effects with regards to postoperative outcome (pain relief, improved functionality, activity, and quality of life), general surgical risks, the patient’s individual risk profile, and the probability that the individual goals will be fulfilled. Information materials which can be easily understood by patients should be available to support the information given to the patient. Ultimately, the consultation will lead to a shared decision for or against surgery. There should be agreement that the expected benefits of surgery will outweigh the possible risks.

The contents of the S2k-guideline on indications for knee endoprosthesis have been summarised in a checklist to allow the recommendations to be easily transferred into routine clinical and surgical practice ([Fig. 1]).

Conflict of Interest

The authors declare that they have no conflict of interest.

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Correspondence

Publication History

Received: 06 October 2023

Accepted after revision: 12 March 2024

Article published online:
29 May 2024

© 2024. Thieme. All rights reserved.

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

• References

• 1 Statistisches Bundesamt (DESTATIS). Die 20 häufigsten Operationen insgesamt (OPS5) 2021. Accessed September 13, 2023 at: https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Gesundheit/Krankenhaeuser/Tabellen/drg-operationen-insgesamt.html
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• 4 Weng Q, Goh SL, Wu J. et al. Comparative efficacy of exercise therapy and oral non-steroidal anti-inflammatory drugs and paracetamol for knee or hip osteoarthritis: a network meta-analysis of randomised controlled trials. Br J Sports Med 2023; 57: 990-996
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• 5 Nakano N, Shoman H, Olavarria F. et al. Why are patients dissatisfied following a total knee replacement? A systematic review. Int Orthop 2020; 44: 1971-2007
  CrossrefPubMedSearch in Google Scholar
• 6 Bannuru RR, Osani MC, Vaysbrot EE. et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage 2019; 27: 1578-1589
  CrossrefPubMedSearch in Google Scholar
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