The STAR care pathway for patients with chronic pain after total knee replacement: four-year follow-up of a randomised controlled trial.

BACKGROUND: The Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway. METHODS: Participants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0-10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon. RESULTS: Overall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p = 0.20) for pain severity and - 0.64 (95% CI -1.41, 0.12); p = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94. CONCLUSIONS: The magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years. TRIAL REGISTRATION: ISRCTN: 92,545,361.

Mortality and re-revision following single-stage and two-stage revision surgery for the management of infected primary hip arthroplasty in England and Wales.

We compared the risks of re-revision and mortality between two-stage and single-stage revision surgeries among patients with infected primary hip arthroplasty. Patients with a periprosthetic joint infection (PJI) of their primary arthroplasty revised with single-stage or two-stage procedure in England and Wales between 2003 and 2014 were identified from the National Joint Registry. We used Poisson regression with restricted cubic splines to compute hazard ratios (HRs) at different postoperative periods. The total number of revisions and re-revisions undergone by patients was compared between the two strategies. In total, 535 primary hip arthroplasties were revised with single-stage procedure (1,525 person-years) and 1,605 with two-stage procedure (5,885 person-years). All-cause re-revision was higher following single-stage revision, especially in the first three months (HR at 3 months = 1.98 (95% confidence interval (CI) 1.14 to 3.43), p = 0.009). The risks were comparable thereafter. Re-revision for PJI was higher in the first three postoperative months for single-stage revision and waned with time (HR at 3 months = 1.81 (95% CI 1.22 to 2.68), p = 0.003; HR at 6 months = 1.25 (95% CI 0.71 to 2.21), p = 0.441; HR at 12 months = 0.94 (95% CI 0.54 to 1.63), p = 0.819). Patients initially managed with a single-stage revision received fewer revision operations (mean 1.3 (SD 0.7) vs 2.2 (SD 0.6), p < 0.001). Mortality rates were comparable between these two procedures (29/10,000 person-years vs 33/10,000). The risk of unplanned re-revision was lower following two-stage revision, but only in the early postoperative period. The lower overall number of revision procedures associated with a single-stage revision strategy and the equivalent mortality rates to two-stage revision are reassuring. With appropriate counselling, single-stage revision is a viable option for the treatment of hip PJI.

Healthcare professionals' views on implementing the STAR care pathway for people with chronic pain after total knee replacement: A qualitative study.

For many people with advanced osteoarthritis, total knee replacement is an effective treatment to relieve pain and improve function. However, 10-34% of people experience chronic postsurgical pain in the months and years after total knee replacement. The Support and Treatment After Replacement (STAR) randomised controlled trial (ISCRTN92545361) evaluated the clinical- and cost-effectiveness of a new multifaceted and personalised care pathway, compared with usual care, for people with pain at three months after total knee replacement. Our objective was to identify factors promoting or inhibiting its implementation, and to inform future training and wider implementation of the pathway. We conducted a prospective process evaluation using qualitative interviews with eight Extended Scope Practitioners and six Principal Investigators from seven trial sites who were involved in delivering the STAR care pathway during the trial. We used Normalization Process Theory as a theoretical framework for qualitative data collection and content analysis. We identified that factors promoting the implementation of the pathway were quick familiarisation with the pathway, valuing patient-centredness, formalising referral processes, and increasing confidence to address neuropathic pain. Challenges to implementation were availability of time and resources, sensitivity in referral process, and ensuring collective understanding of the pathway. These findings have enabled us to make recommendations about the future implementation of the STAR care pathway and will inform the development of a training package, and updated manual for successful delivery in usual care. Furthermore, this model of care has potential value in diverse elective surgeries and pain conditions.

Development of evidence-based guidelines for the treatment and management of periprosthetic hip infection.

Periprosthetic hip-joint infection is a multifaceted and highly detrimental outcome for patients and clinicians. The incidence of prosthetic joint infection reported within two years of primary hip arthroplasty ranges from 0.8% to 2.1%. Costs of treatment are over five-times greater in people with periprosthetic hip joint infection than in those with no infection. Currently, there are no national evidence-based guidelines for treatment and management of this condition to guide clinical practice or to inform clinical study design. The aim of this study is to develop guidelines based on evidence from the six-year INFection and ORthopaedic Management (INFORM) research programme. We used a consensus process consisting of an evidence review to generate items for the guidelines and online consensus questionnaire and virtual face-to-face consensus meeting to draft the guidelines. The consensus panel comprised 21 clinical experts in orthopaedics, primary care, rehabilitation, and healthcare commissioning. The final output from the consensus process was a 14-item guideline. The guidelines make recommendations regarding increased vigilance and monitoring of those at increased risk of infection; diagnosis including strategies to ensure the early recognition of prosthetic infection and referral to orthopaedic teams; treatment, including early use of DAIR and revision strategies; and postoperative management including appropriate physical and psychological support and antibiotic strategies. We believe the implementation of the INFORM guidelines will inform treatment protocols and clinical pathways to improve the treatment and management of periprosthetic hip infection.

Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial.

OBJECTIVES: To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures. DESIGN: Pragmatic, parallel group, open label, randomised controlled trial. SETTING: High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018. PARTICIPANTS: 140 adults (aged ≥18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision). INTERVENTIONS: A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure. MAIN OUTCOME MEASURES: The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups. RESULTS: The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval -8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of £11 167 (95% confidence interval £638 to £21 696) at a £20 000 per quality adjusted life years threshold (£1.0; $1.1; €1.4). CONCLUSIONS: At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery. TRIAL REGISTRATION: ISRCTN registry ISRCTN10956306.

Mortality and re-revision following single-stage and two-stage revision surgery for the management of infected primary knee arthroplasty in England and Wales : evidence from the National Joint Registry.

AIMS: We compared the risks of re-revision and mortality between two-stage revision surgery and single-stage revision surgery among patients with infected primary knee arthroplasty. METHODS: Patients with a periprosthetic joint infection (PJI) of their primary knee arthroplasty, initially revised with a single-stage or a two-stage procedure in England and Wales between 2003 and 2014, were identified from the National Joint Registry. We used Poisson regression with restricted cubic splines to compute hazard ratios (HR) at different postoperative periods. The total number of revisions and re-revisions undergone by patients was compared between the two strategies. RESULTS: A total of 489 primary knee arthroplasties were revised with single-stage procedure (1,390 person-years) and 2,377 with two-stage procedure (8,349 person-years). The adjusted incidence rates of all-cause re-revision and for infection were comparable between these strategies (HR overall five years, 1.15 (95% confidence interval (CI) 0.87 to 1.52), p = 0.308; HR overall five years, 0.99 (95% CI 0.70 to 1.39), p = 0.949, respectively). Patients initially managed with single-stage revision received fewer revision procedures overall than after two-stage revision (1.2 vs 2.2, p < 0.001). Mortality was lower for single-stage revision between six and 18 months postoperative (HR at six months, 0.51 (95% CI 0.25 to 1.00), p = 0.049 HR at 18 months, 0.33 (95% CI 0.12 to 0.99), p = 0.048) and comparable at other timepoints. CONCLUSION: The risk of re-revision was similar between single- and two-stage revision for infected primary knee arthroplasty. Single-stage group required fewer revisions overall, with lower or comparable mortality at specific postoperative periods. The single-stage revision is a safe and effective strategy to treat infected knee arthroplasties. There is potential for increased use to reduce the burden of knee PJI for patients, and for the healthcare system.Cite this article: Bone Joint Res 2022;11(10):690-699.

The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial.

BACKGROUND: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. METHODS: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0-10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361. FINDINGS: Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was -0·65 (95% CI -1·17 to -0·13; p=0·014) and the mean between-group difference in the BPI interference score was -0·68 (-1·29 to -0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group. INTERPRETATION: STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. FUNDING: National Institute for Health Research.

Common elective orthopaedic procedures and their clinical effectiveness: umbrella review of level 1 evidence.

OBJECTIVE: To determine the clinical effectiveness of common elective orthopaedic procedures compared with no treatment, placebo, or non-operative care and assess the impact on clinical guidelines. DESIGN: Umbrella review of meta-analyses of randomised controlled trials or other study designs in the absence of meta-analyses of randomised controlled trials. DATA SOURCES: Ten of the most common elective orthopaedic procedures-arthroscopic anterior cruciate ligament reconstruction, arthroscopic meniscal repair of the knee, arthroscopic partial meniscectomy of the knee, arthroscopic rotator cuff repair, arthroscopic subacromial decompression, carpal tunnel decompression, lumbar spine decompression, lumbar spine fusion, total hip replacement, and total knee replacement-were studied. Medline, Embase, Cochrane Library, and bibliographies were searched until September 2020. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Meta-analyses of randomised controlled trials (or in the absence of meta-analysis other study designs) that compared the clinical effectiveness of any of the 10 orthopaedic procedures with no treatment, placebo, or non-operative care. DATA EXTRACTION AND SYNTHESIS: Summary data were extracted by two independent investigators, and a consensus was reached with the involvement of a third. The methodological quality of each meta-analysis was assessed using the Assessment of Multiple Systematic Reviews instrument. The Jadad decision algorithm was used to ascertain which meta-analysis represented the best evidence. The National Institute for Health and Care Excellence Evidence search was used to check whether recommendations for each procedure reflected the body of evidence. MAIN OUTCOME MEASURES: Quality and quantity of evidence behind common elective orthopaedic interventions and comparisons with the strength of recommendations in relevant national clinical guidelines. RESULTS: Randomised controlled trial evidence supports the superiority of carpal tunnel decompression and total knee replacement over non-operative care. No randomised controlled trials specifically compared total hip replacement or meniscal repair with non-operative care. Trial evidence for the other six procedures showed no benefit over non-operative care. CONCLUSIONS: Although they may be effective overall or in certain subgroups, no strong, high quality evidence base shows that many commonly performed elective orthopaedic procedures are more effective than non-operative alternatives. Despite the lack of strong evidence, some of these procedures are still recommended by national guidelines in certain situations. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018115917.

Choice between implants in knee replacement: protocol for a Bayesian network meta-analysis, analysis of joint registries and economic decision model to determine the effectiveness and cost-effectiveness of knee implants for NHS patients-The KNee Implant Prostheses Study (KNIPS).

INTRODUCTION: Knee replacements are highly successful for many people, but if a knee replacement fails, revision surgery is generally required. Surgeons and patients may choose from a range of implant components and combinations that make up knee replacement constructs, all with potential implications for how long a knee replacement will last. To inform surgeon and patient decisions, a comprehensive synthesis of data from randomised controlled trials is needed to evaluate the effects of different knee replacement implants on overall construct survival. Due to limited follow-up in trials, joint registry analyses are also needed to assess the long-term survival of constructs. Finally, economic modelling can identify cost-effective knee replacement constructs for different patient groups. METHODS AND ANALYSIS: In this protocol, we describe systematic reviews and network meta-analyses to synthesise evidence on the effectiveness of knee replacement constructs used in total and unicompartmental knee replacement and analyses of two national joint registries to assess long-term outcomes. Knee replacement constructs are defined by bearing materials and mobility, constraint, fixation and patella resurfacing. For men and women in different age groups, we will compare the lifetime cost-effectiveness of knee replacement constructs. ETHICS AND DISSEMINATION: Systematic reviews are secondary analyses of published data with no ethical approval required. We will design a common joint registry analysis plan and provide registry representatives with information for submission to research or ethics committees. The project has been assessed by the National Health Service (NHS) REC committee and does not require ethical review.Study findings will be disseminated to clinicians, researchers and administrators through open access articles, presentations and websites. Specific UK-based groups will be informed of results including National Institute for Health Research and National Institute for Health and Care Excellence, as well as international orthopaedic associations and charities. Effective dissemination to patients will be guided by our patient-public involvement group and include written lay summaries and infographics. PROSPERO REGISTRATION NUMBER: CRD42019134059 and CRD42019138015.

Patients Receiving a Primary Unicompartmental Knee Replacement Have a Higher Risk of Revision but a Lower Risk of Mortality Than Predicted Had They Received a Total Knee Replacement: Data From the National Joint Registry for England, Wales, Northern Ireland, and the Isle of Man.

BACKGROUND: To determine unicompartmental (UKR) and total knee replacement (TKR) revision rates, compare UKR revision rates with what they would have been had they received TKR instead, and assess subsequent re-revision and 90-day mortality rates. METHODS: Using National Joint Registry data, we estimated UKR and TKR revision and mortality rates. Flexible parametric survival modeling (FPM) was used to model failure in TKR and make estimates for UKR. Kaplan-Meier estimates were used to compare cumulative re-revision for revised UKRs and TKRs. RESULTS: Ten-year UKR revision rates were 2.5 times higher than expected from TKR, equivalent to 70 excess revisions/1000 cases within 10 years (5861 excess revisions in this cohort). Revision rates were 2.5 times higher for the highest quartile volume UKR surgeons compared to the same quartile for TKR and 3.9 times higher for the lowest quartiles respectively. Re-revision rates of revised TKRs (10 years = 17.5%, 95% confidence interval [CI] 16.4-18.7) were similar to revised UKRs (15.2%, 95% CI 13.4-17.1) and higher than revision rates following primary TKR (3.3%, 95% CI 3.1-3.5). Ninety-day mortality rates were lower after UKR compared with TKR (0.08% vs 0.33%) and lower than predicted had UKR patients received a TKR (0.18%), equivalent to 1 fewer death per 1000 cases. CONCLUSION: UKR revision rates were substantially higher than TKR even when demographics and caseload differences were accounted for; however, fewer deaths occur after UKR. This should be considered when forming treatment guidelines and commissioning services. Re-revision rates were similar between revised UKRs and TKRs, but considerably higher than for primary TKR, therefore UKR cannot be considered an intermediate procedure.

Outcomes following primary total hip arthroplasty with pre-existing spinal fusion surgery.

AIMS: There is inconsistent evidence on whether prior spinal fusion surgery adversely impacts outcomes following total hip arthroplasty (THA). We conducted a systematic review and meta-analysis to assess the association between pre-existing spinal fusion surgery and the rate of complications following primary THA. METHODS: We searched MEDLINE, Embase, Web of Science, and Cochrane Library up to October 2019 for randomized controlled trials (RCTs) and observational studies comparing outcomes of dislocation, revision, or reasons for revision in patients following primary THA with or without pre-existing spinal fusion surgery. Furthermore, we compared short (two or less levels) or long (three or more levels) spinal fusions to no fusion. Summary measures of association were relative risks (RRs) (with 95% confidence intervals (CIs)). RESULTS: We identified ten articles corresponding to nine unique observational studies comprising of 1,992,366 primary THAs. No RCTs were identified. There were 32,945 cases of spinal fusion and 1,752,362 non-cases. Comparing prior spinal fusion versus no spinal fusion in primary THA, RRs (95% CI) for dislocation was 2.23 (1.81 to 2.74; seven studies), revision 2.14 (1.63 to 2.83; five studies), periprosthetic joint infection 1.71 (1.53 to 1.92; four studies), periprosthetic fracture 1.52 (1.28 to 1.81; three studies), aseptic loosening 1.76 (1.54 to 2.01; three studies), and any complications 2.82 (1.37 to 5.80; three studies) were identified. Both short and long spinal fusions, when compared with no fusion, were associated dislocation, revision, or reasons for revision. CONCLUSIONS: Patients with prior spinal fusion are at risk of adverse events following primary THA. Measures that reduce the risk of these complications should be considered in this high-risk population when undergoing primary THA. These patients should also be counselled appropriately around their risks of undergoing THA. Cite this article: Bone Joint J 2020;102-B(6):664-670.

Incidence, temporal trends and potential risk factors for prosthetic joint infection after primary total shoulder and elbow replacement: Systematic review and meta-analysis.

OBJECTIVES: We conducted a systematic meta-analysis to evaluate the incidence, temporal trends and potential risk factors for prosthetic joint infection (PJI) following primary total shoulder replacement (TSR) and elbow replacement (TER). METHODS: Longitudinal studies reporting infection outcomes following primary TSR or TER were sought from MEDLINE, Embase and Cochrane Library up to June 2019. Incidence rates and relative risks (with 95% CIs) were calculated. RESULTS: The search identified 105 eligible articles (108 non-overlapping studies). There were 631,854 TSRs (1,751 PJIs) and 17,485 TERs (525 PJIs). The pooled PJI incidence following TSR was 0.61% (0.34-0.93) over a follow-up period of 1.1 years. The corresponding incidence following TER was 2.53% (1.99-3.12) over a follow-up period of 3.3 years. Shoulder and elbow PJI incidence declined from the 1990s to 2010 and beyond. Males, younger age (<75 years), previous shoulder surgery, reverse TSR, rotator cuff arthropathy and inpatient TSR increased shoulder PJI risk. For TER, high body mass index, psychiatric illness, and previous elbow surgery increased PJI risk. CONCLUSIONS: Shoulder and elbow PJI may be on a temporal decline. Caution should be taken for patients at high PJI risk following primary TSR such as younger males and patients with a previous shoulder surgery.

Effect of Group-Based Outpatient Physical Therapy on Function After Total Knee Replacement: Results From a Multicenter Randomized Controlled Trial.

OBJECTIVE: To evaluate the long-term clinical effectiveness of a novel group-based outpatient physical therapy (PT) following total knee replacement (TKR). METHODS: In this 2-center, unblinded, superiority, randomized controlled trial, 180 patients on a waiting list for primary TKR due to osteoarthritis were randomized to a 6 session group-based outpatient PT intervention and usual care (n = 89) or usual care alone (n = 91). The primary outcome was patient-reported functional ability measured by the Lower Extremity Functional Scale at 12 months postoperative. Secondary outcomes included knee symptoms, depression, anxiety, and satisfaction. Questionnaires were completed preoperatively and at 3, 6, and 12 months postoperatively. RESULTS: The mean difference in function between groups was 4.47 (95% confidence interval [95% CI] 0.20, 8.75; P = 0.04) at 12 months postoperative, favoring the intervention. The mean difference in function between groups decreased over time, from 8.1 points at 3 months (95% CI 3.8, 12.4; P < 0.001) to 5.4 (95% CI 1.1, 9.8; P = 0.015) at 6 months postoperative. There were no clinically relevant differences in any secondary outcomes between groups, although patients in the intervention group were more likely to be satisfied with their PT. No serious adverse events related to the intervention were reported. CONCLUSION: Supplementing usual care with this group-based outpatient PT intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimum clinically important difference of 9 points. However, patient satisfaction was higher in the intervention group, and there was some evidence of clinically relevant improvements in function at 3 months.

Does vitamin E highly-crosslinked polyethylene convey an advantage in primary total hip replacement? A systematic review and meta-analysis.

BACKGROUND: Vitamin E highly cross-linked polyethylene (HXLPE) was developed to reduce wear in total hip replacement (THR). This formal systematic review and meta-analysis aimed to provide independent synthesis of wear characteristics of Vitamin E treated HXLPE compared to HXPLE/UHMWPE. Secondary outcome measures were differences in revision rates and functional scores. METHODS: We performed a formal systematic review as per PRISMA guidelines; literature searches were conducted on 14 November 2017 (MEDLINE, Embase on Ovid, and the Cochrane Library). We included randomised controlled trials, analyses of joint registries, and case-controlled studies of primary THR comparing cups with a vitamin E HXLPE bearing with bearing surfaces made from other types of polyethylene. Initial screening was performed by 2 independent assessors; disagreement resolved in discussion with a third reviewer. Studies were evaluated using the Cochrane risk of bias tool. Data extraction permitted meta-analysis. RESULTS: 372 studies were identified on initial screening, 5 studies met the eligibility criteria. There was no significant heterogeneity between studies. There was variable risk of bias. At a mean of 35 (range 20-60) months, Vitamin E HXLPE had significant advantages over highly cross-linked polyethylene with regards total femoral head penetration (p = 0.004). Given the RSA measurement errors this may not be clinically significant.There were neither significant differences in revision rates nor Harris Hip Scores (p = 0.06). CONCLUSION: At a minimum of 3 years follow-up there was reduced total femoral head penetration for vitamin E HXLPE over HXLPE. This bearing surface does not, as yet, have clinically significant advantages in terms of revision rates or patient function over HXLPE.

One- and two-stage surgical revision of infected elbow prostheses following total joint replacement: a systematic review.

BACKGROUND: Prosthetic joint infection (PJI) is a challenging complication of total elbow replacement (TER). Potential surgical treatments include one- or two-stage revision; however, the best treatment for elbow PJI is not clearly defined. We conducted a systematic review in accordance with PRISMA guidelines to compare the clinical effectiveness of one- and two-stage revision surgery for elbow PJI using re-infection (recurrent and new infections) rates; mortality; clinical measures of function, pain, and satisfaction; and non-infection related adverse events. METHODS: MEDLINE, Embase, Web of Science, and The Cochrane Library were searched up to June 2019 to identify observational cohort studies and randomised controlled trials (RCTs) that had recruited patients with elbow PJI following TER and treated with one- or two-stage revision. Of 96 retrieved articles, 2 one-stage and 6 two-stage revision studies were eligible. No RCT was identified. Arcsine transformation was used in estimating rates with 95% confidence intervals (CIs). RESULTS: Staphylococcus aureus was the most common causative organism for PJI of the elbow (24 of 71 elbow PJIs). The re-infection rate (95% CI) for one-stage (7 elbows) ranged from 0.0% (0.0-79.3) to 16.7% (3.0-56.4) and that for two-stage revision (87 elbows) from 0.0% (0.0-49.0) to 20.0% (3.6-62.4). Non-infection related adverse event rate for one-stage (based on a single study) was 16.7% (3.0-56.4) and that for two-stage ranged from 11.8% (4.7-26.6) to 20.0% (3.6-62.4). There were no mortality events recorded following one- or two-stage revision surgery and postoperative clinical measures of function, pain, and satisfaction could not be effectively compared because of limited data. CONCLUSIONS: No strong conclusions can be drawn because of limited data. The one-stage revision may be potentially at least as clinically effective as two-stage revision, but further data is needed. There are clear gaps in the existing literature and studies are urgently warranted to assess the clinical effectiveness of one- and two-stage revision strategies for PJI following TER. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2018: CRD42018118002 .

Influence of Fixation Methods on Prosthetic Joint Infection Following Primary Total Knee Replacement: Meta-Analysis of Observational Cohort and Randomised Intervention Studies.

The type of fixation used in primary total knee replacement (TKR) may influence the risk of prosthetic joint infection (PJI). We conducted a systematic review and meta-analysis to assess published evidence linking type of fixation (cemented, uncemented, or hybrid) with the risk of PJI following primary TKR. Randomised controlled trials (RCTs) and observational cohort studies comparing fixation methods and reporting PJI incidence following primary TKR were identified in MEDLINE, Embase, Web of Science, and Cochrane Library up until November 2018. Summary measures were relative risks (RR) with 95% confidence intervals (CIs). We identified 32 eligible articles (24 observational studies and 8 RCTs) involving 1,161,292 TKRs. In pooled analysis of observational studies, uncemented fixation was associated with a decreased overall PJI risk when compared with cemented fixation at 0.76 (0.64-0.89). Comparing antibiotic-loaded cemented fixation with plain cement, there was no significant difference in overall PJI risk at 0.95 (0.69-1.31), but PJI risk was increased in the first 6-month postoperative period to 1.65 (1.12-2.43). Limited data from RCTs showed no differences in PJI risk among the fixation types. Observational evidence suggests uncemented fixation may be associated with lower PJI risk in primary TKR when compared with cemented fixation. In the early postoperative period, antibiotic-loaded cemented fixation may be associated with increased PJI risk when compared with plain cement. This may either reflect appropriate selection of higher risk patients for the development of PJI to cemented and antibiotic-loaded cement or may reflect a lower PJI risk in uncemented TKR due to factors such as shorter operative time.

Implant Fixation and Risk of Prosthetic Joint Infection Following Primary Total Hip Replacement: Meta-Analysis of Observational Cohort and Randomised Intervention Studies.

Prosthetic joint infection (PJI), although uncommon, is a dreaded and devastating complication of total hip replacement (THR). Whether implant-related factors, such as the fixation method, influences the risk of PJI following THR is contentious. We conducted a systematic review and meta-analysis to evaluate the body of evidence linking fixation methods (cemented, uncemented, hybrid, or reverse hybrid) with the risk of PJI following primary THR. Observational studies and randomised controlled trials (RCTs) comparing fixation methods, and reporting PJI incidence following THR, were identified through MEDLINE, Embase, Web of Science, Cochrane Library, and reference lists of relevant studies up to 24 April 2019. Summary measures were relative risks (RRs) (95% confidence intervals, CIs). We identified 22 eligible articles (based on 11 distinct observational cohort studies comprising 2,260,428 THRs and 4 RCTs comprising 945 THRs). In pooled analyses of observational studies, all cemented fixations (plain and antibiotic combined), plain cemented fixations, hybrid fixations, and reverse hybrid fixations were each associated with an increased overall PJI risk when compared with uncemented fixations: 1.10 (95% CI: 1.04-1.17), 1.50 (95% CI: 1.27-1.77), 1.49 (95% CI: 1.36-1.64), and 1.49 (95% CI: 1.14-1.95), respectively. However, in the first six months, uncemented fixations were associated with increased PJI risk when compared to all cemented fixations. Compared to antibiotic-loaded cemented fixations, plain cemented fixations were associated with an increased PJI risk (1.52; 95% CI: 1.36-1.70). One RCT showed an increased PJI risk comparing plain cemented fixations with antibiotic-loaded cemented fixations. Uncemented and antibiotic-loaded cemented fixations remain options for the prevention of PJI in primary THR.

Risk factors associated with revision for prosthetic joint infection following knee replacement: an observational cohort study from England and Wales.

BACKGROUND: Prosthetic joint infection is a devastating complication of knee replacement. The risk of developing a prosthetic joint infection is affected by patient, surgical, and health-care system factors. Existing evidence is limited by heterogeneity in populations studied, short follow-up, inadequate power, and does not differentiate early prosthetic joint infection, most likely related to the intervention, from late infection, more likely to occur due to haematogenous bacterial spread. We aimed to assess the overall and time-specific associations of these factors with the risk of revision due to prosthetic joint infection following primary knee replacement. METHODS: In this cohort study, we analysed primary knee replacements done between 2003 and 2013 in England and Wales and the procedures subsequently revised for prosthetic joint infection between 2003 and 2014. Data were obtained from the National Joint Registry linked to the Hospital Episode Statistics data in England and the Patient Episode Database for Wales. Each primary replacement was followed for a minimum of 12 months until the end of the observation period (Dec 31, 2014) or until the date of revision for prosthetic joint infection, revision for another indication, or death (whichever occurred first). We analysed the data using Poisson and piecewise exponential multilevel models to assess the associations between patient, surgical, and health-care system factors and risk of revision for prosthetic joint infection. FINDINGS: Of 679 010 primary knee replacements done between 2003 and 2013 in England and Wales, 3659 were subsequently revised for an indication of prosthetic joint infection between 2003 and 2014, after a median follow-up of 4·6 years (IQR 2·6-6·9). Male sex (rate ratio [RR] for male vs female patients 1·8 [95% CI 1·7-2·0]), younger age (RR for age ≥80 years vs <60 years 0·5 [0·4-0·6]), higher American Society of Anaesthesiologists [ASA] grade (RR for ASA grade 3-5 vs 1, 1·8 [1·6-2·1]), elevated body-mass index (BMI; RR for BMI ≥30 kg/m2vs <25 kg/m2 1·5 [1·3-1·6]), chronic pulmonary disease (RR 1·2 [1·1-1·3]), diabetes (RR 1·4 [1·2-1·5]), liver disease (RR 2·2 [1·6-2·9]), connective tissue and rheumatic diseases (RR 1·5 [1·3-1·7]), peripheral vascular disease (RR 1·4 [1·1-1·7]), surgery for trauma (RR 1·9 [1·4-2·6]), previous septic arthritis (RR 4·9 [2·7-7·6]) or inflammatory arthropathy (RR 1·4 [1·2-1·7]), operation under general anaesthesia (RR 1·1 [1·0-1·2]), requirement for tibial bone graft (RR 2·0 [1·3-2·7]), use of posterior stabilised fixed bearing prostheses (RR for posterior stabilised fixed bearing prostheses vs unconstrained fixed bearing prostheses 1·4 [1·3-1·5]) or constrained condylar prostheses (3·5 [2·5-4·7]) were associated with a higher risk of revision for prosthetic joint infection. However, uncemented total, patellofemoral, or unicondylar knee replacement (RR for uncemented vs cemented total knee replacement 0·7 [95% CI 0·6-0·8], RR for patellofemoral vs cemented total knee replacement 0·3 [0·2-0·5], and RR for unicondylar vs cemented total knee replacement 0·5 [0·5-0·6]) were associated with lower risk of revision for prosthetic joint infection. Most of these factors had time-specific effects, depending on the time period post-surgery. INTERPRETATION: We have identified several risk factors for revision for prosthetic joint infection following knee replacement. Some of these factors are modifiable, and the use of targeted interventions or strategies could lead to a reduced risk of revision for prosthetic joint infection. Non-modifiable factors and the time-specific nature of the effects we have observed will allow clinicians to appropriately counsel patients preoperatively and tailor follow-up regimens. FUNDING: National Institute for Health Research.

Choice of Prosthetic Implant Combinations in Total Hip Replacement: Cost-Effectiveness Analysis Using UK and Swedish Hip Joint Registries Data.

BACKGROUND: Prosthetic implants used in total hip replacements (THR) have a range of bearing surface combinations (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, and metal-on-metal), head sizes (small [<36 mm in diameter] and large [≥36 mm in diameter]), and fixation techniques (cemented, uncemented, hybrid, and reverse hybrid). These can influence prosthesis survival, patients' quality of life, and healthcare costs. OBJECTIVES: To compare the lifetime cost-effectiveness of implants for patients of different age and sex profiles. METHODS: We developed a Markov model to compare the cost-effectiveness of various implants against small-head cemented metal-on-polyethylene implants. The probability that patients required 1 or more revision surgeries was estimated from analyses of more than 1 million patients in the UK and Swedish hip joint registries, for men and women younger than 55, 55 to 64, 65 to 74, 75 to 84, and 85 years and older. Implant and healthcare costs were estimated from local procurement prices, national tariffs, and the literature. Quality-adjusted life-years were calculated using published utility estimates for patients undergoing THR in the United Kingdom. RESULTS: Small-head cemented metal-on-polyethylene implants were the most cost-effective for men and women older than 65 years. These findings were robust to sensitivity analyses. Small-head cemented ceramic-on-polyethylene implants were most cost-effective in men and women younger than 65 years, but these results were more uncertain. CONCLUSIONS: The older the patient group, the more likely that the cheapest implants, small-head cemented metal-on-polyethylene implants, were cost-effective. We found no evidence that uncemented, hybrid, or reverse hybrid implants were the most cost-effective option for any patient group. Our findings can influence clinical practice and procurement decisions for healthcare payers worldwide.

One- and two-stage surgical revision of infected shoulder prostheses following arthroplasty surgery: A systematic review and meta-analysis.

Periprosthetic joint infection (PJI) is a catastrophic complication of shoulder arthroplasty. Commonly used surgical treatments include one- or two-stage revision, but their effectiveness in controlling infection is uncertain. We aimed to compare re-infection (recurrent and new infections) rates; clinical measures of function and pain; and noninfection complication rates of one- and two-stage revision surgery for shoulder PJI using a systematic review and meta-analysis. We searched MEDLINE, Embase, Web of Science, and The Cochrane Library to February 2018. Longitudinal studies conducted in patients with shoulder PJI treated exclusively by one- or two-stage revision were eligible. No clinical trials were identified. Re-infection rates were meta-analysed using random-effect models after arcsine transformation. The re-infection rate (95% CI) in pooled analysis of eight one-stage studies (147 participants) was 5.3% (1.4-10.6). The corresponding rate for 27 two-stage studies (351 participants) was 11.5% (6.0-18.1). Postoperative clinical measures of function and pain were not significantly different between the two revision strategies. The pooled noninfection complication rate (95% CI) for one-stage and two-stage revision was 12.1% (6.1-19.5) and 18.9% (8.4-31.9) respectively. New evidence suggests one-stage revision is at least equally as effective as the two-stage in controlling infection, maintaining joint function, and improving complications in shoulder PJI.