The results of hip and knee replacement surgery are generally regarded as positive for patients. Nonetheless, they are both major operations and have recognised complications. We present a review of relevant claims made to the National Health Service Litigation Authority. Between 1995 and 2010 there were 1004 claims to a value of £41.5 million following hip replacement surgery and 523 claims to a value of £21 million for knee replacement. The most common complaint after hip surgery was related to residual neurological deficit, whereas after knee replacement it was related to infection. Vascular complications resulted in the highest costs per case in each group.

Although there has been a large increase in the number of operations performed, there has not been a corresponding relative increase in litigation. The reasons for litigation have remained largely unchanged over time after hip replacement. In the case of knee replacement, although there has been a reduction in claims for infection, there has been an increase in claims for technical errors. There has also been a rise in claims for non-specified dissatisfaction. This information is of value to surgeons and can be used to minimise the potential mismatch between patient expectation, informed consent and outcome.

Cite this article: Bone Joint J 2013;95-B:122–6.

The aim of this study was to perform a cost–utility analysis of total hip (THR) and knee replacement (TKR). Arthritis is a disabling condition that leads to long-term deterioration in quality of life. Total joint replacement, despite being one of the greatest advances in medicine of the modern era, has recently come under scrutiny. The National Health Service (NHS) has competing demands, and resource allocation is challenging in times of economic restraint. Patients who underwent THR (n = 348) or TKR (n = 323) between January and July 2010 in one Scottish region were entered into a prospective arthroplasty database. A health–utility score was derived from the EuroQol (EQ-5D) score pre-operatively and at one year, and was combined with individual life expectancy to derive the quality-adjusted life years (QALYs) gained. Two-way analysis of variance was used to compare QALYs gained between procedures, while controlling for baseline differences. The number of QALYs gained was higher after THR than after TKR (6.5 vs 4.0 years, p < 0.001). The cost per QALY for THR was £1372 compared with £2101 for TKR. The predictors of an increase in QALYs gained were poorer health before surgery (p < 0.001) and younger age (p < 0.001). General health (EQ-5D VAS) showed greater improvement after THR than after TKR (p < 0.001). This study provides up-to-date cost-effectiveness data for total joint replacement. THR and TKR are extremely effective both clinically and in terms of cost effectiveness, with costs that compare favourably to those of other medical interventions.

Cite this article: Bone Joint J 2013;95-B:115–21.

Post-operative complications after total hip or knee replacement can delay recovery, prolong hospitalisation, increase rates of re-admission and, in the most severe cases, lead to long-term disability or even death. In this analysis of pooled data from four large, randomised, phase III clinical trials that compared the oral, direct Factor Xa inhibitor rivaroxaban with subcutaneous enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement (n = 12 729), the incidence of complications, including bleeding and adverse events related to surgery (such as wound infection, wound dehiscence and haemarthrosis) are reported. Interventions and procedures relating to surgery are also compared between the groups. Bleeding events, including excessive wound haematoma and surgical-site bleeding, occurred at similar rates in the rivaroxaban and enoxaparin groups. Over the total study duration, adverse surgical events occurred at a similar rate in the rivaroxaban group compared with the enoxaparin group after total knee replacement (2.26% vs 2.69%, respectively) and total hip replacement (1.48% vs 1.65%, respectively). Blood loss, wound drainage and transfusion requirements were also similar between the two groups.

This analysis shows that the incidence of adverse surgical events with rivaroxaban was similar to enoxaparin.

Obtaining a balanced flexion gap with correct femoral component rotation is one of the prerequisites for a successful outcome after total knee replacement (TKR). Different techniques for achieving this have been described. In this study we prospectively compared gap-balancing versus measured resection in terms of reliability and accuracy for femoral component rotation in 96 primary TKRs performed in 96 patients using the Journey system. In 48 patients (18 men and 30 women) with a mean age of 65 years (45 to 85) a tensor device was used to determine rotation. In the second group of 48 patients (14 men and 34 women) with a mean age of 64 years (41 to 86), an ‘adapted’ measured resection technique was used, taking into account the native rotational geometry of the femur as measured on a pre-operative CT scan.

Both groups systematically reproduced a similar external rotation of the femoral component relative to the surgical transepicondylar axis: 2.4° (sd 2.5) in the gap-balancing group and 1.7° (sd 2.1) in the measured resection group (p = 0.134). Both gap-balancing and adapted measured resection techniques proved equally reliable and accurate in determining femoral component rotation after TKR. There was a tendency towards more external rotation in the gap-balancing group, but this difference was not statistically significant (p = 0.134). The number of outliers for our ‘adapted’ measured resection technique was much lower than reported in the literature.

Using general practitioner records and hospital notes and through direct telephone conversation with patients, we investigated the accuracy of nine patient-reported complications gathered from a self-completed questionnaire after elective joint replacement surgery of the hip and knee. A total of 402 post-discharge complications were reported after 8546 elective operations that were undertaken within a three-year period. These were reported by 136 men and 240 women with a mean age of 71.8 years (34 to 93). A total of 319 reported complications (79.4%; 95% confidence interval 75.4 to 83.3) were confirmed to be correct. High rates of correct reporting were demonstrated for infection (94.5%) and the need for further surgery (100%), whereas the rates of reporting deep-vein thrombosis (DVT), pulmonary embolism, myocardial infarction and stroke were lower (75% to 84.2%). Dislocation, peri-prosthetic fractures and nerve palsy had modest rates of correct reporting (36% to 57.1%). More patients who had knee surgery delivered incorrect reports of dislocation (p = 0.001) and DVT (p = 0.013).

Despite these variations, it appears that post-operative complications may form part of a larger patient-reported outcome programme after elective joint replacement surgery.

We report a systematic review and meta-analysis of the peer-reviewed literature focusing on metal sensitivity testing in patients undergoing total joint replacement (TJR). Our purpose was to assess the risk of developing metal hypersensitivity post-operatively and its relationship with outcome and to investigate the advantages of performing hypersensitivity testing.

We undertook a comprehensive search of the citations quoted in PubMed and EMBASE: 22 articles (comprising 3634 patients) met the inclusion criteria. The frequency of positive tests increased after TJR, especially in patients with implant failure or a metal-on-metal coupling. The probability of developing a metal allergy was higher post-operatively (odds ratio (OR) 1.52 (95% confidence interval (CI) 1.06 to 2.31)), and the risk was further increased when failed implants were compared with stable TJRs (OR 2.76 (95% CI 1.14 to 6.70)).

Hypersensitivity testing was not able to discriminate between stable and failed TJRs, as its predictive value was not statistically proven. However, it is generally thought that hypersensitivity testing should be performed in patients with a history of metal allergy and in failed TJRs, especially with metal-on-metal implants and when the cause of the loosening is doubtful.

Patient expectations and their fulfilment are an important factor in determining patient-reported outcome and satisfaction of hip (THR) and knee replacement (TKR). The aim of this prospective cohort study was to examine the expectations of patients undergoing THR and TKR, and to identify differences in expectations, predictors of high expectations and the relationship between the fulfilment of expectations and patient-reported outcome measures. During the study period, patients who underwent 346 THRs and 323 TKRs completed an expectation questionnaire, Oxford score and Short-Form 12 (SF-12) score pre-operatively. At one year post-operatively, the Oxford score, SF-12, patient satisfaction and expectation fulfilment were assessed. Univariable and multivariable analysis were performed. Improvements in mobility and daytime pain were the most important expectations in both groups. Expectation level did not differ between THR and TKR. Poor Oxford score, younger age and male gender significantly predicted high pre-operative expectations (p < 0.001). The level of pre-operative expectation was not significantly associated with the fulfilment of expectations or outcome. THR better met the expectations identified as important by patients. TKR failed to meet expectations of kneeling, squatting and stair climbing. High fulfilment of expectation in both THR and TKR was significantly predicted by young age, greater improvements in Oxford score and high pre-operative mental health scores. The fulfilment of expectations was highly correlated with satisfaction.

We obtained information from the Elective Orthopaedic Centre on 1523 patients with baseline and six-month Oxford hip scores (OHS) after undergoing primary hip replacement (THR) and 1784 patients with Oxford knee scores (OKS) for primary knee replacement (TKR) who completed a six-month satisfaction questionnaire.

Receiver operating characteristic curves identified an absolute change in OHS of 14 points or more as the point that discriminates best between patients’ satisfaction levels and an 11-point change for the OKS. Satisfaction is highest (97.6%) in patients with an absolute change in OHS of 14 points or more, compared with lower levels of satisfaction (81.8%) below this threshold. Similarly, an 11-point absolute change in OKS was associated with 95.4% satisfaction compared with 76.5% below this threshold. For the six-month OHS a score of 35 points or more distinguished patients with the highest satisfaction level, and for the six-month OKS 30 points or more identified the highest level of satisfaction. The thresholds varied according to patients’ pre-operative score, where those with severe pre-operative pain/function required a lower six-month score to achieve the highest levels of satisfaction.

Our data suggest that the choice of a six-month follow-up to assess patient-reported outcomes of THR/TKR is acceptable. The thresholds help to differentiate between patients with different levels of satisfaction, but external validation will be required prior to general implementation in clinical practice.

In order to compare the effect of oral apixaban (a factor Xa inhibitor) with subcutaneous enoxaparin on major venous thromboembolism and major and non-major clinically relevant bleeding after total knee and hip replacement, we conducted a pooled analysis of two previously reported double-blind randomised studies involving 8464 patients. One group received apixaban 2.5 mg twice daily (plus placebo injection) starting 12 to 24 hours after operation, and the other received enoxaparin subcutaneously once daily (and placebo tablets) starting 12 hours (± 3) pre-operatively. Each regimen was continued for 12 days (± 2) after knee and 35 days (± 3) after hip arthroplasty. All outcomes were centrally adjudicated. Major venous thromboembolism occurred in 23 of 3394 (0.7%) evaluable apixaban patients and in 51 of 3394 (1.5%) evaluable enoxaparin patients (risk difference, apixaban minus enoxaparin, -0.8% (95% confidence interval (CI) -1.2 to -0.3); two-sided p = 0.001 for superiority). Major bleeding occurred in 31 of 4174 (0.7%) apixaban patients and 32 of 4167 (0.8%) enoxaparin patients (risk difference -0.02% (95% CI -0.4 to 0.4)). Combined major and clinically relevant non-major bleeding occurred in 182 (4.4%) apixaban patients and 206 (4.9%) enoxaparin patients (risk difference -0.6% (95% CI -1.5 to 0.3)).

Apixaban 2.5 mg twice daily is more effective than enoxaparin 40 mg once daily without increased bleeding.

Patient warming significantly decreases the risk of surgical site infection. Recently there have been concerns that forced air warming may interfere with unidirectional airflow, potentially posing an increased risk of infection. Our null hypothesis was that forced air and radiant warming devices do not increase the temperature and the number of particles over the surgical site when compared with no warming device. A forced air warming device was compared with a radiant warming device and no warming device as a control. The temperature and number of particles were measured over the surgical site. The theatre was prepared as for a routine lower-limb arthroplasty operation, and the same volunteer was used throughout the study.

Forced air warming resulted in a significant mean increase in the temperature (1.1°C vs 0.4°C, p < 0.0001) and number of particles (1038.2 vs 274.8, p = 0.0087) over the surgical site when compared with radiant warming, which raises concern as bacteria are known to require particles for transport.

Patients with infected arthroplasties are normally treated with a two-stage exchange procedure using polymethylmethacrylate bone cement spacers impregnated with antibiotics. However, spacers may act as a foreign body to which micro-organisms may adhere and grow. In this study it was hypothesised that subclinical infection may be diagnosed with sonication of the surface biofilm of the spacer. The aims were to assess the presence of subclinical infection through sonication of the spacer at the time of a second-stage procedure, and to determine the relationship between subclinical infection and the clinical outcome. Of 55 patients studied, 11 (20%) were diagnosed with subclinical infection. At a mean follow-up of 12 months (interquartile range 6 to 18), clinical failure was found in 18 (32.7%) patients. Of the patients previously diagnosed with subclinical infection, 63% (7 of 11) had failed compared with 25% (11 of 44) of those without subclinical infection (odds ratio 5.25, 95% confidence interval 1.29 to 21.4, p = 0.021). Sonication of the biofilm of the surface of the spacer is useful in order to exclude subclinical infection and therefore contributes to improving the outcome after two-stage procedures.

We performed a meta-analysis of modern total joint replacement (TJR) to determine the post-operative mortality and the cause of death using different thromboprophylactic regimens as follows: 1) no routine chemothromboprophylaxis (NRC); 2) Potent anticoagulation (PA) (unfractionated or low-molecular-weight heparin, ximelagatran, fondaparinux or rivaroxaban); 3) Potent anticoagulation combined (PAC) with regional anaesthesia and/or pneumatic compression devices (PCDs); 4) Warfarin (W); 5) Warfarin combined (WAC) with regional anaesthesia and/or PCD; and 6) Multimodal (MM) prophylaxis, including regional anaesthesia, PCDs and aspirin in low-risk patients. Cause of death was classified as autopsy proven, clinically certain or unknown. Deaths were grouped into cardiopulmonary excluding pulmonary embolism (PE), PE, bleeding-related, gastrointestinal, central nervous system, and others (miscellaneous). Meta-analysis based on fixed effects or random effects models was used for pooling incidence data.

In all, 70 studies were included (99 441 patients; 373 deaths). The mortality was lowest in the MM (0.2%) and WC (0.2%) groups. The most frequent cause of death was cardiopulmonary (47.9%), followed by PE (25.4%) and bleeding (8.9%). The proportion of deaths due to PE was not significantly affected by the thromboprophylaxis regimen (PA, 35.5%; PAC, 28%; MM, 23.2%; and NRC, 16.3%). Fatal bleeding was higher in groups relying on the use of anticoagulation (W, 33.8%; PA, 9.4%; PAC, 10.8%) but the differences were not statistically significant.

Our study demonstrated that the routine use of PA does not reduce the overall mortality or the proportion of deaths due to PE.

Primary arthroplasty may be denied to very elderly patients based upon the perceived outcome and risks associated with surgery. This prospective study compared the outcome, complications, and mortality of total hip (TKR) and total knee replacement (TKR) in a prospectively selected group of patients aged ≥ 80 years with that of a control group aged between 65 and 74 years. There were 171 and 495 THRs and 185 and 492 TKRs performed in the older and control groups, respectively. No significant difference was observed in the mean improvement of Oxford hip and knee scores between the groups at 12 months (0.98, (95% confidence interval (CI) −0.66 to 2.95), p = 0.34 and 1.15 (95% CI −0.65 to 2.94), p = 0.16, respectively). The control group had a significantly (p = 0.02 and p = 0.04, respectively) greater improvement in the physical well being component of their SF-12 score, but the older group was more satisfied with their THR (p = 0.047). The older group had a longer hospital stay for both THR (5.9 versus 9.0 days, p < 0.0001) and TKR (6.2 versus 8.3 days, p < 0.0001). The rates of post-operative complications and mortality were increased in the older group.

Biofilm-associated infections in wounds or on implants are difficult to treat. Eradication of the bacteria is nearly always impossible, despite the use of specific antibiotics. The bactericidal effects of high-energy extracorporeal shock waves on Staphylococcus aureus have been reported, but the effect of low-energy shock waves on staphylococci and staphylococcal biofilms has not been investigated. In this study, biofilms grown on stainless steel washers were examined by electron microscopy. We tested ten experimental groups with Staph. aureus-coated washers and eight groups with Staph. epidermidis.

The biofilm-cultured washers were exposed to low-energy shock waves at 0.16 mJ/mm² for 500 impulses. The washers were then treated with cefuroxime, rifampicin and fosfomycin, both alone and in combination. All tests were carried out in triplicate. Viable cells were counted to determine the bactericidal effect.

The control groups of Staph. aureus and Staph. epidermidis revealed a cell count of 6 × 10⁸ colony-forming units/ml. Complete eradication was achieved using the combination of antibiotic therapy (single antibiotic in Staph. aureus, a combination in Staph. epidermidis) and shock wave application (p < 0.01).

We conclude that shock waves combined with antibiotics could be tested in an in vitro model of infection.

Prophylaxis against venous thromboembolism after elective total hip replacement is routinely recommended. Our preference has been to use mechanical prophylaxis without anticoagulant drugs. A randomised controlled trial was performed to evaluate whether the incidence of post-operative venous thromboembolism was reduced by using pharmacological anticoagulation with either fondaparinux or enoxaparin in addition to our prophylactic mechanical regimen. A total of 255 Japanese patients who underwent primary unilateral cementless total hip replacement were randomly assigned to one of three postoperative regimens, namely injection of placebo (saline), fondaparinux or enoxaparin. There were 85 patients in each group. All also received the same mechanical prophylaxis during and after the operation, regardless of their assigned group. The primary measurement of efficacy was the presence of a venous thromboembolic event by day 11, defined as deep-vein thrombosis detected by ultrasonography, documented symptomatic deep-vein thrombosis or documented symptomatic pulmonary embolism. The duration of follow-up was 12 weeks.

The rate of venous thromboembolism was 7.2% with the placebo, 7.1% with fondaparinux and 6.0% with enoxaparin (p = 0.95 for the comparison of all three groups). Our study confirmed the effectiveness and safety of mechanical thromboprophylaxis without the use of anticoagulant drugs after total hip replacement in Japanese patients.

We have investigated whether the use of laminar-flow theatres and space suits reduced the rate of revision for early deep infection after total hip (THR) and knee (TKR) replacement by reviewing the results of the New Zealand Joint Registry at ten years.

Of the 51 485 primary THRs and 36 826 primary TKRs analysed, laminar-flow theatres were used in 35.5% and space suits in 23.5%. For THR there was a significant increase in early infection in those procedures performed with the use of a space suit compared with those without (p < 0.0001), in those carried out in a laminar-flow theatre compared with a conventional theatre (p < 0.003) and in those undertaken in a laminar-flow theatre with a space suit (p < 0.001) when compared with conventional theatres without such a suit. The results were similar for TKR with the use of a space suit (p < 0.001), in laminar-flow theatres (p < 0.019) and when space suits were used in those theatres (p < 0.001). These findings were independent of age, disease and operating time and were unchanged when the surgeons and hospital were analysed individually.

The rate of revision for early deep infection has not been reduced by using laminar flow and space suits. Our results question the rationale for their increasing use in routine joint replacement, where the added cost to the health system seems to be unjustified.

Rivaroxaban has been recommended for routine use as a thromboprophylactic agent in patients undergoing lower-limb arthroplasty. However, trials supporting its use have not fully evaluated the risks of wound complications. This study of 1048 total hip/knee replacements records the rates of return to theatre and infection before and after the change from a low molecular weight heparin (tinzaparin) to rivaroxaban as the agent of chemical thromboprophylaxis in patients undergoing lower-limb arthroplasty. During a period of 13 months, 489 consecutive patients undergoing lower-limb arthroplasty received tinzaparin and the next 559 consecutive patients received rivaroxaban as thromboprophylaxis.

Nine patients in the control (tinzaparin) group (1.8%, 95% confidence interval 0.9 to 3.5) returned to theatre with wound complications within 30 days, compared with 22 patients in the rivaroxaban group (3.94%, 95% confidence interval 2.6 to 5.9). This increase was statistically significant (p = 0.046). The proportion of patients who returned to theatre and became infected remained similar (p = 0.10).

Our study demonstrates the need for further randomised controlled clinical trials to be conducted to assess the safety and efficacy of rivaroxaban in clinical practice, focusing on the surgical complications as well as the potential prevention of venous thromboembolism.

Peri-prosthetic fracture after joint replacement in the lower limb is associated with significant morbidity. The primary aim of this study was to investigate the incidence of peri-prosthetic fracture after total hip replacement (THR) and total knee replacement (TKR) over a ten-year period using a population-based linked dataset.

Between 1 April 1997 and 31 March 2008, 52 136 primary THRs, 8726 revision THRs, 44 511 primary TKRs, and 3222 revision TKRs were performed. Five years post-operatively, the rate of fracture was 0.9% after primary THR, 4.2% after revision THR, 0.6% after primary TKR and 1.7% after revision TKR. Comparison of survival analysis for all primary and revision arthroplasties showed peri-prosthetic fractures were more likely in females, patients aged > 70 and after revision arthroplasty.

Female patients aged > 70 should be warned of a significantly increased risk of peri-prosthetic fracture after hip or knee replacement. The use of adjuvant medical treatment to reduce the effect of peri-prosthetic osteoporosis may be a direction of research for these patients.

A new generation of knee prostheses has been introduced with the intention of improving post-operative knee flexion. In order to evaluate whether this goal has been achieved we performed a systematic review and meta-analysis. Systematic literature searches were conducted on MEDLINE and EMBASE from their inception to December 2007, and proceedings of scientific meetings were also searched. Only randomised, clinical trials were included in the meta-analysis. The mean difference in the maximum post-operative flexion between the ‘high-flex’ and conventional types of prosthesis was defined as the primary outcome measure. A total of five relevant articles was identified.

Analysis of these trials suggested that no clinically relevant or statistically significant improvement was obtained in flexion with the ‘high-flex’ prostheses. The weighted mean difference was 2.1° (95% confidence interval −0.2 to +4.3; p = 0.07).

Infection remains a significant and common complication after joint replacement and there is debate about which contributing factors are important. Few studies have investigated the effect of the operating time on infection.

We collected data prospectively from 5277 hip and knee replacements which included the type of procedure, the operating time, the use of drains, the operating theatre, surgeon, age and gender. In a subgroup of 3449 knee replacements further analysis was carried out using the tourniquet time in place of the operating time. These variables were assessed by the use of generalised linear modelling against superficial, deep or joint-space post-operative infection as defined by the Australian Surgical-Site Infection criteria.

The overall infection rate was 0.98%. In the replacement data set both male gender (z = 3.097, p = 0.00195) and prolonged operating time (z = 4.325, p < 0.001) were predictive of infection. In the knee subgroup male gender (z = 2.250, p = 0.02447), a longer tourniquet time (z = 2.867, p = 0.00414) and total knee replacement (versus unicompartmental knee replacement) (z = −2.052, p = 0.0420) were predictive of infection.

These findings support the view that a prolonged operating time and male gender are associated with an increased incidence of infection. Steps to minimise intra-operative delay should be instigated, and care should be exercised when introducing measures which prolong the duration of joint replacement.