Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature.

BACKGROUND: It is not known, whether outcome reporting in trials of total joint arthroplasty in the recent years is adequate or not. Our objective was to assess whether outcomes reported in total joint replacement (TJR) trials fulfil the Outcome Measures in Rheumatology (OMERACT) Filter 2.0. METHODS: We systematically reviewed all TJR trials in adults, published in English in 2008 or 2013. Searches were conducted in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE. Two authors independently applied the inclusion criteria for the studies, and any disagreement was resolved with a third review author. All outcome measures were abstracted using a pre-piloted standardised data extraction form and assessed for whether they mapped to one of the three OMERACT Filter 2.0 core areas: pathophysiological, life impact, and death. RESULTS: From 1635 trials identified, we included 70 trials (30 in 2008 and 40 in 2013) meeting the eligibility criteria. Twenty-two (31%) trials reported the three essential OMERACT core areas. Among the 27 hip replacement surgery trials and 39 knee replacement surgery trials included, 11 hip (41%) and nine knee (23%) trials reported all three essential OMERACT core areas. The most common outcome domains/measures were pain (20/27, 74%) and function (23/27, 85%) in hip trials and pain (26/39, 67%) and function (27/39, 69%) in knee trials. Results were similar for shoulder and hand joint replacement trials. CONCLUSIONS: We identified significant gaps in the measurement of OMERACT core outcome areas in TJR trials, despite the majority reporting outcome domains of pain and function. An international consensus of key stakeholders is needed to develop a core domain set for reporting of TJR trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014009216.

Outcome Measures Used in Arthroplasty Trials: Systematic Review of the 2008 and 2013 Literature.

OBJECTIVE: Previously published literature assessing the reporting of outcome measures used in joint replacement randomized controlled trials (RCT) has revealed disappointing results. It remains unknown whether international initiatives have led to any improvement in the quality of reporting and/or a reduction in the heterogeneity of outcome measures used. Our objective was to systematically assess and compare primary outcome measures and the risk of bias in joint replacement RCT published in 2008 and 2013. METHODS: We searched MEDLINE, EMBASE, and CENTRAL for RCT investigating adult patients undergoing joint replacement surgery. Two authors independently identified eligible trials, extracted data, and assessed risk of bias using the Cochrane tool. RESULTS: Seventy RCT (30 in 2008, 40 in 2013) met the eligibility criteria. There was no significant difference in the number of trials judged to be at low overall risk of bias (n = 6, 20%) in 2008 compared with 2013 [6 (15%); chi-square = 0.302, p = 0.75]. Significantly more trials published in 2008 did not specify a primary outcome measure (n = 25, 83%) compared with 18 trials (45%) in 2013 (chi-square = 10.6316, p = 0.001). When specified, there was significant heterogeneity in the measures used to assess primary outcomes. CONCLUSION: While less than a quarter of trials published in both 2008 and 2013 were judged to be at low overall risk of bias, significantly more trials published in 2013 specified a primary outcome. Although this might represent a temporal trend toward improvement, the overall frequency of primary outcome reporting and the wide heterogeneity in primary outcomes reported remain suboptimal.

The Efficacy of Medial Patellofemoral Ligament Reconstruction Combined with Tibial Tuberosity Transfer in the Treatment of Patellofemoral Instability.

A systematic review of the literature was undertaken to evaluate the efficacy of medial patellofemoral ligament (MPFL) reconstruction combined with tibial tuberosity transfer (TTT) in the treatment of patellofemoral instability. Using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a systematic search was carried out to identify and review the published literature pertinent to MFPL reconstruction combined with TTT. Relevant studies were critically appraised with narrative data synthesis. Studies that met the eligibility criteria were suitable for appraisal and consisted of case series and therapeutic series (levels IV & III). All studies had inherent variations in outcomes reporting and limited follow-up. Combined treatment offers restoration of normal anatomy, thus adding clinical value to the currently recommended anatomic approach to MPFL reconstruction. Nevertheless, the current body of evidence does not determine the threshold at which patellofemoral axis requires the need for adjunctive distal realignment as opposed to MPFL reconstruction alone. This review highlighted numerous recurring limitations in the conduct and presentation of the studies, which inadvertently mitigated the interpretation of their results. Future priority should be awarded to larger randomised controlled trials utilising validated patient reported outcome measures.

The surgical management of symptomatic articular cartilage defects of the knee: Consensus statements from United Kingdom knee surgeons.

BACKGROUND: Symptomatic articular cartilage and osteochondral lesions in the knee are an important source of pain and disability, and may lead to osteoarthritis. There are several surgical treatments for the condition, with emerging data evaluating their clinical effectiveness and longer-term clinical outcome. Health care providers have challenged the indications for the use of expensive techniques and have been reluctant to authorize funding or reimbursement. METHODS: The UK Cartilage Consensus Meeting was convened, involving clinicians in the UK with experience in the treatment options, decision-making and evaluation of the literature on the subject. RESULTS: This paper reports the consensus of attendees regarding appropriate surgical options for managing articular cartilage defects in the knee, validated by a large cohort of surgeons in the UK who are active in the field of articular cartilage surgery. CONCLUSIONS: An evidence-based United Kingdom Consensus of 104 clinicians on the surgical management of symptomatic articular cartilage lesions of the knee. Several techniques may be suitable for small defects. Cell therapy has the best evidence-based outcomes for larger defects. Responsible innovation, pooled data collection and improvement in physical therapies are important. Surgeons should have access to the most appropriate evidence-based therapies for first-line treatment.

Outcome Domains and Measures in Total Joint Replacement Clinical Trials: Can We Harmonize Them? An OMERACT Collaborative Initiative.

OBJECTIVE: To develop a plan for harmonizing outcomes for people undergoing total joint replacement (TJR), to achieve consensus regarding TJR outcome research. METHODS: The TJR working group met during the 2014 Outcome Measures in Rheumatology (OMERACT) 12 meeting in Budapest, Hungary. Multiple conference calls preceded the face-to-face meeting. Brief presentations were made during a 1.5-h meeting, which included an overview of published systematic reviews of TJR trials and the results of a recent systematic review of TJR clinical trial outcome domains and measures. This was followed by discussion of potential core set areas/domains for TJR clinical trials (as per OMERACT Filter 2.0) as well as the challenges associated with the measurement of these domains. RESULTS: Working group participants discussed which TJR clinical trial outcome domains/areas map to the inner versus outer core for core domain set. Several challenges were identified with TJR outcomes including how to best measure function after TJR, elucidating the source of the pre- and post-TJR joint pain being measured, joint-specific versus generic quality of life instruments and the importance of patient satisfaction and revision surgery as outcomes. A preliminary core domain set for TJR clinical trials was proposed and included pain, function, patient satisfaction, revision, adverse events, and death. This core domain set will be further vetted with a broader audience. CONCLUSION: An international effort with active collaboration with the orthopedic community to standardize key outcome domains and measures is under way with the TJR working group. This effort will be further developed with new collaborations.

Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study.

BACKGROUND: Enhanced recovery programmes in total knee arthroplasty are well established. Post-operative knee swelling is common and impairs early post-operative function. The use of a short-stretch, inelastic compression bandage is hypothesised to reduce knee swelling and improve pain and early function. A study was designed to test feasibility with a view to informing a larger, future trial and to provide preliminary data. METHODS/DESIGN: This is a randomised controlled feasibility study. Fifty consecutive patients selected for primary total knee arthroplasty will be enrolled in the trial. Patients with a BMI >35, latex allergy or neurological or peripheral vascular disease are excluded. Patients are randomised by distance randomisation to receive a compression bandage for 24 hours after surgery or a standard wool and crepe bandage. The bandages are applied by one of two consultant surgeons who have had training with their application. Knee swelling, range of motion and pain scores will be compared pre-operatively and at day 1, day 2 and at 6 weeks between groups. The Oxford knee score and EQ-5D health status will be compared pre-operatively and at 6 months between groups. Recruitment rates, retention rates, resource allocation, completeness of data collection, and tolerance and complications with the compression bandage are recorded. Descriptive statistics are used to calculate a standard deviation for post-operative knee swelling in the groups and to perform a power calculation incorporating anticipated patient retention rates to inform a future trial. Preliminary data will be analysed using the independent samples t-test for equal distributions and the Mann-Whitney U for unequal distributions with the significance denoted at P <0.05. DISCUSSION: Enhanced recovery programmes have revolutionized the management of total knee arthroplasty. There is a paucity of clinical data regarding the efficacy of compression bandages. Large, randomised controlled trials are uncommon in orthopaedic surgery. The results of this study will provide feasibility and preliminary data prior to the construction of a larger, multicentre study. TRIAL REGISTRATION: The study was registered with Current Controlled Trials ( ISRCTN86903140 ) on 30 May 2013.

Review of the role of dynamic 18F-NaF PET in diagnosing and distinguishing between septic and aseptic loosening in hip prosthesis.

Joint replacements may fail due to infection, dislocation, peri-prosthetic fracture and loosening. Between 0.4 and 4% of joint replacements are known to be complicated by infection and aseptic loosening 2-18%. Differentiating between infection and aseptic loosening has an important bearing on the ongoing strategy for antimicrobial therapy and surgical intervention, but distinguishing one from the other can be difficult and will often require a battery of clinical and biochemical tests including the use of varying radiological modalities to accurately identify whether problematic joints are infected or aseptically loose. Prompt diagnosis is important due to the development of a biofilm on the surface of the infected prosthesis, which makes treatment difficult. There is no consensus among experts on the ideal imaging technique nor the methodology for image interpretation, but there is an increasing trend to apply hybrid imaging in the investigation of painful joint prosthesis and recent attempts have been made using PET-CT to identify aseptic loosening and infection with (18)F-fluorodeoxyglucose (FDG) and sodium fluoride (18)F-Na. The aim of this paper is to evaluate the role of (18)F-NaF sodium fluoride ((18)F-NaF) positron emission tomography (PET) in distinguishing between septic and aseptic failure in hip and knee replacements, in addition to evaluating the feasibility of using multi-sequential (18)F-NaF PET-CT for the assessment of painful lower limb prostheses.

Meniscal integrity predicts laxity of anterior cruciate ligament reconstruction.

PURPOSE: The aim of this study was to evaluate the incidence of failure of anterior cruciate ligament (ACL) reconstruction and to assess the prognostic factors for such an outcome. METHODS: A prospective inception cohort of patients undergoing ACL reconstruction was analysed for failure (patient reported symptoms of rotational instability, a clinically positive pivot shift, MRI or arthroscopy showing ACL graft rupture). Risk factors evaluated included medial and lateral meniscal deficiency, medial and lateral meniscal repair, age, gender, BMI, graft size and time to surgery. Survival analysis was performed using the Kaplan-Meier method. Prognostic factors were assessed using the Cox proportional hazard model to investigate whether covariate risk factors influenced graft survival. RESULTS: One hundred and twenty-three patients were available for final analysis at a follow-up of 2 years. Eighteen patients satisfied the criteria of failure (15.4 %). Risk factors for failure were medial meniscal deficiency (hazard ratio 4.5; 95 % CI 1.8-11.5; p = 0.002), or lateral meniscal deficiency (hazard ratio 3.5; 95 % CI 1.3-9.3; p = 0.01). At 2-year follow-up, ACL survival was 94.5 % (95 % CI 89-100) for patients with intact menisci and 69 % (95 % CI 56-86) for those with deficiency of the medial or lateral meniscus (log-rank test p = 0.017). Patients were 4.9 times more likely to fail if they had a deficient medial or lateral meniscus. Those patients who underwent meniscal repair did not demonstrate any increased risk of failure. CONCLUSION: Medial and lateral meniscal tears are important prognostic factors that influence the survival of ACL reconstruction. Surgeons should endeavour to repair all meniscal tears associated with ACL reconstruction. LEVEL OF EVIDENCE: II.

Does intraoperative tissue sample enrichment help or hinder the identification of microorganisms in prosthetic joint infection?

OBJECTIVES: Biofilm formation reduces the efficacy of standard microbiological techniques in prosthetic joint infection. This study aimed to investigate the sensitivity, specificity and predictive values of tissue sample enrichment as a means to increase diagnostic yield. METHODS: Patients undergoing revision arthroplasty surgery between May 2004 and January 2013 had intraoperative tissue samples cultured in standard media as well as enriched in brain heart infusion broth. Patients were separated into infected or non-infected groups according to modified criteria from the Musculoskeletal Infection Society. RESULTS: A total of 197 revision arthroplasties were included (non-infected, n = 165; proven infection, n = 32). The mean time until revision in non-infected and infected groups was 75.9 and 41.7 months, respectively. The commonest microorganisms cultured were coagulase-negative staphylococci (42.9 %) and Staphylococcus aureus (34.4 %). The sensitivity and specificity of standard tissue culture were 0.25 (CI 0.18-0.33) and 0.98 (CI 0.95-0.99), respectively. Including enrichment culture results increased the sensitivity to 0.45 (CI 0.37-0.54), but decreased specificity to 0.59 (CI 0.52-0.66). CONCLUSION: Any potential increase in the sensitivity is far outweighed by the extremely high false-positive rate. Results of tissue samples cultured by enrichment should be used with caution and may lead to a worse outcome if incorrectly interpreted.

Development of an outcome prediction tool for patients considering a total knee replacement--the Knee Outcome Prediction Study (KOPS).

BACKGROUND: Knee osteoarthritis affects 10% of the UK population over 55 years, resulting in pain and decreased quality of life. Knee replacement surgery has a proven benefit, with over 85,000 performed each year in the UK; however, approximately 17% of people are dissatisfied after surgery. Consequently, some Primary Care Trusts have reduced the funding available for knee replacements.Most previous work has focused on the effect of different prostheses and treatment protocols on patient's outcome. However, this has been unable to account for all the variability and there is growing evidence that patient factors may significantly affect outcome. How to identify these at risk patients has been identified as a research priority by the National Institute of Clinical Excellence, the British Orthopedic Association, and the National Joint Registry.The aim of this study is to develop a clinically appropriate outcome prediction tool based on measurable predictors affecting outcome. METHODS/DESIGN: We propose a prospective cohort study, designed to develop and validate an outcome prediction tool based on patient factors.Six hundred patients who are scheduled for total knee replacement secondary to primary osteoarthritis will be recruited before surgery from all six hospitals (NHS and private) that provide total knee replacements to the population of Coventry and Warwickshire (UK). Patients will complete a baseline assessment of patient factors before their operation and will be followed up at 6 and 12 months post surgery. DISCUSSION: A clinically appropriate outcome prediction tool will allow patients to make a more informed decision regarding surgery. Aligning patient expectations with a realistic prediction of outcome should improve satisfaction. Ultimately, this project is likely to inform national policy making and regional service provision.

A case series of 35 hip revisions for adverse reactions to metal debris following Cormet hip resurfacing.

The primary aim of this study was to analyse our painful metal-on-metal (MoM) hip resurfacing revisions with evidence of 'adverse reactions to metal debris' (ARMD). In our series of 35 revisions the median whole blood Cobalt levels were 58 nmols/l (range 12-1407 nmols/l), and whole blood Chromium levels were 73 nmols/l (range 2-353 nmols/l). Thirty-four of our 35 patients had abnormal imaging on Ultrasound scanning (USS). The mean histological Campbell grading of ARMD was 4, and ranged from 0-9. The mean Oxford Hip Score (OHS) increased from 19 pre-revision (range 4-46) to 33 post-revision surgery (range 23-47).We found no correlation between the preoperative metal ion levels, and the severity of the disease or the outcome.Pain following hip resurfacing may arise from a number of causes and when groin pain arises in conjunction with abnormal cross sectional imaging we have offered our patients revision surgery regardless of raised metal ions or grossly abnormal imaging, with good results.

The effect of triclosan coated sutures on rate of surgical site infection after hip and knee replacement: a protocol for a double-blind randomised controlled trial.

BACKGROUND: 187,000 hip and knee joint replacements are performed every year in the National Health Service (NHS). One of the commonest complications is surgical site infection (SSI), and this represents a significant burden in terms of patient morbidity, mortality and cost to health services around the world. The aim of this randomised controlled trial (RCT) is to determine if the addition of triclosan coated sutures to a standard regimen can reduce the rate of SSI after total knee replacement (TKR) and total hip replacement (THR). METHODS: 2400 patients due to undergo a total hip or knee replacement are being recruited into this two-centre RCT. Participants are recruited before surgery and randomised to either standard care or intervention group. Participants, outcome assessors and statistician are blind to treatment allocation throughout the study. The intervention consists of triclosan coated sutures vs. standard non-coated sutures. The primary outcome is the Health protection Agency (HPA) defined superficial surgical site infection at 30 days. Secondary outcomes include HPA defined deep surgical site infection at 12 months, length of hospital stay, critical care stay, and payer costs. DISCUSSION: To date there are no orthopaedic randomised controlled trials on this scale assessing the effectiveness of a surgical intervention, particularly those that can be translated across the surgical specialities. The results from this trial will inform evidence-based recommendations for suture selection in the management of patients undergoing total hip or knee replacement. If triclosan coated sutures are found to be an effective intervention, implementation into clinical practice could improve long-term outcomes for patients undergoing hip and knee replacement. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 17807356.

Sensitivities, specificities, and predictive values of microbiological culture techniques for the diagnosis of prosthetic joint infection.

BACKGROUND: Identifying the microorganism in a prosthetic joint infection is the key to appropriately targeting antimicrobial treatment. Despite the availability of various techniques, no single test is considered the definitive gold standard. AIM: Our aim was to determine the sensitivity, specificity, and positive/negative predictive values for a variety of culture techniques. METHODS: We performed a retrospective case series of 219 patients undergoing revision surgery of their hip or knee replacement between May 2004 and February 2013. The patients were classified as either infected or noninfected according to criteria set out by the Musculoskeletal Infection Society. The number and type of samples taken intraoperatively varied between cases but included tissue samples and fluid sent in either blood culture vials or sterile containers. RESULTS: The highest sensitivity was found with blood culture vials (0.85) compared to fluid in sterile containers (0.26) and tissues samples (0.32). Blood culture vials also had a better specificity and positive and negative predictive values profile. CONCLUSION: We conclude that, of the techniques studied, fluid in blood culture vials had the best profile for the correct identification of microorganisms and advocate its use.

Preoperative education for hip or knee replacement.

BACKGROUND: Hip or knee replacement is a major surgical procedure that can be physically and psychologically stressful for patients. It is hypothesised that education before surgery reduces anxiety and enhances clinically important postoperative outcomes. OBJECTIVES: To determine whether preoperative education in people undergoing total hip replacement or total knee replacement improves postoperative outcomes with respect to pain, function, health-related quality of life, anxiety, length of hospital stay and the incidence of adverse events (e.g. deep vein thrombosis). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (2013, Issue 5), MEDLINE (1966 to May 2013), EMBASE (1980 to May 2013), CINAHL (1982 to May 2013), PsycINFO (1872 to May 2013) and PEDro to July 2010. We handsearched the Australian Journal of Physiotherapy (1954 to 2009) and reviewed the reference lists of included trials and other relevant reviews. SELECTION CRITERIA: Randomised or quasi-randomised trials of preoperative education (verbal, written or audiovisual) delivered by a health professional within six weeks of surgery to people undergoing hip or knee replacement compared with usual care. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. We analysed dichotomous outcomes using risk ratios. We combined continuous outcomes using mean differences (MD) or standardised mean differences (SMD) with 95% confidence intervals (CI). Where possible, we pooled data using a random-effects meta-analysis. MAIN RESULTS: We included 18 trials (1463 participants) in the review. Thirteen trials involved people undergoing hip replacement, three involved people undergoing knee replacement and two included both people with hip and knee replacements. Only six trials reported using an adequate method of allocation concealment, and only two trials blinded participants. Few trials reported sufficient data to analyse the major outcomes of the review (pain, function, health-related quality of life, global assessment, postoperative anxiety, total adverse events and re-operation rate). There did not appear to be an effect of time on any outcome, so we chose to include only the latest time point available per outcome in the review.In people undergoing hip replacement, preoperative education may not offer additional benefits over usual care. The mean postoperative anxiety score at six weeks with usual care was 32.16 on a 60-point scale (lower score represents less anxiety) and was 2.28 points lower with preoperative education (95% confidence interval (CI) -5.68 to 1.12; 3 RCTs, 264 participants, low-quality evidence), an absolute risk difference of -4% (95% CI -10% to 2%). The mean pain score up to three months postoperatively with usual care was 3.1 on a 10-point scale (lower score represents less pain) and was 0.34 points lower with preoperative education (95% CI -0.94 to 0.26; 3 RCTs, 227 participants; low-quality evidence), an absolute risk difference of -3% (95% CI -9% to 3%). The mean function score at 3 to 24 months postoperatively with usual care was 18.4 on a 68-point scale (lower score represents better function) and was 4.84 points lower with preoperative education (95% CI -10.23 to 0.66; 4 RCTs, 177 participants; low-quality evidence), an absolute risk difference of -7% (95% CI -15% to 1%). The number of people reporting adverse events, such as infection and deep vein thrombosis, did not differ between groups, but the effect estimates are uncertain due to very low quality evidence (23% (17/75) reported events with usual care versus 18% (14/75) with preoperative education; risk ratio (RR) 0.79; 95% CI 0.19 to 3.21; 2 RCTs, 150 participants). Health-related quality of life, global assessment of treatment success and re-operation rates were not reported.In people undergoing knee replacement, preoperative education may not offer additional benefits over usual care. The mean pain score at 12 months postoperatively with usual care was 80 on a 100-point scale (lower score represents less pain) and was 2 points lower with preoperative education (95% CI -3.45 to 7.45; 1 RCT, 109 participants), an absolute risk difference of -2% (95% CI -4% to 8%). The mean function score at 12 months postoperatively with usual care was 77 on a 100-point scale (lower score represents better function) and was no different with preoperative education (0; 95% CI -5.63 to 5.63; 1 RCT, 109 participants), an absolute risk difference of 0% (95% CI -6% to 6%). The mean health-related quality of life score at 12 months postoperatively with usual care was 41 on a 100-point scale (lower score represents worse quality of life) and was 3 points lower with preoperative education (95% CI -6.38 to 0.38; 1 RCT, 109 participants), an absolute risk difference of -3% (95% CI -6% to 1%). The number of people reporting adverse events, such as infection and deep vein thrombosis, did not differ between groups (18% (11/60) reported events with usual care versus 13% (7/55) with preoperative education; RR 0.69; 95% CI 0.29 to 1.66; 1 RCT, 115 participants), an absolute risk difference of -6% (-19% to 8%). Global assessment of treatment success, postoperative anxiety and re-operation rates were not reported. AUTHORS' CONCLUSIONS: Although preoperative education is embedded in the consent process, we are unsure if it offers benefits over usual care in terms of reducing anxiety, or in surgical outcomes, such as pain, function and adverse events. Preoperative education may represent a useful adjunct, with low risk of undesirable effects, particularly in certain patients, for example people with depression, anxiety or unrealistic expectations, who may respond well to preoperative education that is stratified according to their physical, psychological and social need.

Are the claims made in orthopaedic print advertisements valid?

PURPOSE: Advertisements are commonplace in orthopaedic journals and may influence the readership with claims of clinical and scientific fact. Since the last assessment of the claims made in orthopaedic print advertisements ten years ago, there have been legislative changes and media scrutiny which have shaped this practice. The purpose of this study is to re-evaluate these claims. METHODS: Fifty claims from 50 advertisements were chosen randomly from six highly respected peer-reviewed orthopaedic journals (published July-December 2011). The evidence supporting each claim was assessed and validated by three orthopaedic surgeons. The assessors, blinded to product and company, rated the evidence and answered the following questions: Does the evidence as presented support the claim made in the advertisement and what is the quality of that evidence? Is the claim supported by enough evidence to influence your own clinical practice? RESULTS: Twenty-eight claims cited evidence from published literature, four from public presentations, 11 from manufacturer "data held on file" and seven had no supporting evidence. Only 12 claims were considered to have high-quality evidence and only 11 were considered well supported. A strong correlation was seen between the quality of evidence and strength of support (Spearman r = 0.945, p < 0.0001). The average ICC between the assessors' ratings was strong (r = 0.85) giving validity to the results. CONCLUSION: Orthopaedic surgeons must remain sceptical about the claims made in print advertisements. High-quality evidence is required by orthopaedic surgeons to influence clinical practice and this evidence should be sought by manufacturers wishing to market a successful product.

Medial Patellofemoral Ligament Reconstruction for Patellar Dislocation: A Systematic Review.

BACKGROUND: With improved understanding of the biomechanical importance of the medial patellofemoral ligament (MPFL), its reconstruction for patellar dislocation has become increasingly popular. The aim of this systematic review was to critically determine the effectiveness of MPFL reconstruction for patellar dislocation. HYPOTHESIS: MPFL reconstruction for patellar dislocation leads to a low redislocation rate with improved Kujala scores. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: A literature search was performed using Embase and Medline (Ovid) databases. Inclusion criteria included first-time and recurrent patellar dislocation, subluxation, or persistent instability with a minimum follow-up of 12 months and documentation of postoperative redislocation rate or Kujala score. The studies were systematically appraised, and a meta-analysis was performed. RESULTS: Twenty-two studies were included: 2 randomized controlled trials, 3 parallel case series, and 17 case series. There were a total of 655 knees in the review, with an age range at time of surgery from 11 to 52 years. The pooled postoperative redislocation rate from all 17 case series showed a mean of 2.44%. The pooled preoperative Kujala scores from 12 case series showed a mean of 51.6 (95% CI, 46.71-56.49). The pooled postoperative Kujala scores from 16 case series showed a mean of 87.77 (95% CI, 85.15-90.39). CONCLUSION: Although the studies were of low quality, the meta-analysis of 17 case series shows that MPFL reconstruction for recurrent patellar dislocation results in a significant improvement in Kujala scores, a low redislocation rate, and acceptable complication rate. Randomized trials would be needed to draw influences on the superiority of MPFL reconstruction compared with other treatments.

The effect of high dose antibiotic impregnated cement on rate of surgical site infection after hip hemiarthroplasty for fractured neck of femur: a protocol for a double-blind quasi randomised controlled trial.

BACKGROUND: Mortality following hip hemiarthroplasty is in the range of 10-40% in the first year, with much attributed to post-operative complications. One such complication is surgical site infection (SSI), which at the start of this trial affected 4.68% of patients in the UK having this operation. Compared to SSI rates of elective hip surgery, at less than 1%, this figure is elevated. The aim of this quasi randomised controlled trial (RCT) is to determine if high dose antibiotic impregnated cement can reduce the SSI in patients at 12-months after hemiarthroplasty for intracapsular fractured neck of femur. METHODS: 848 patients with an intracapsular fractured neck of femur requiring a hip hemiarthroplasty are been recruited into this two-centre double-blind quasi RCT. Participants were recruited before surgery and quasi randomised to standard care or intervention group. Participants, statistician and outcome assessors were blind to treatment allocation throughout the study. The intervention consisted of high dose antibiotic impregnated cement consisting of 1 gram Clindamycin and 1 gram of Gentamicin. The primary outcome is Health Protection Agency (HPA) defined deep surgical site infection at 12 months. Secondary outcomes include HPA defined superficial surgical site infection at 30 days, 30 and 90-day mortality, length of hospital stay, critical care stay, and complications. DISCUSSION: Large randomised controlled trials assessing the effectiveness of a surgical intervention are uncommon, particularly in the speciality of orthopaedics. The results from this trial will inform evidence-based recommendations for antibiotic impregnated cement in the management of patients with a fractured neck of femur undergoing a hip hemiarthroplasty. If high dose antibiotic impregnated cement is found to be an effective intervention, implementation into clinical practice could improve long-term outcomes for patients undergoing hip hemiarthroplasty. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN25633145.

A systematic review of the evidence for single stage and two stage revision of infected knee replacement.

BACKGROUND: Periprosthetic infection about the knee is a devastating complication that may affect between 1% and 5% of knee replacement. With over 79 000 knee replacements being implanted each year in the UK, periprosthetic infection (PJI) is set to become an important burden of disease and cost to the healthcare economy. One of the important controversies in treatment of PJI is whether a single stage revision operation is superior to a two-stage procedure. This study sought to systematically evaluate the published evidence to determine which technique had lowest reinfection rates. METHODS: A systematic review of the literature was undertaken using the MEDLINE and EMBASE databases with the aim to identify existing studies that present the outcomes of each surgical technique. Reinfection rate was the primary outcome measure. Studies of specific subsets of patients such as resistant organisms were excluded. RESULTS: 63 studies were identified that met the inclusion criteria. The majority of which (58) were reports of two-stage revision. Reinfection rated varied between 0% and 41% in two-stage studies, and 0% and 11% in single stage studies. No clinical trials were identified and the majority of studies were observational studies. CONCLUSIONS: Evidence for both one-stage and two-stage revision is largely of low quality. The evidence basis for two-stage revision is significantly larger, and further work into direct comparison between the two techniques should be undertaken as a priority.