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 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.

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.

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.

The assessment of neutrophil CD64 count as an early warning marker of joint replacement infection.

120,000 hip and knee replacements are performed each year in the UK and more than 1 % of these require revision surgery due to infection. Current diagnostic tests used to diagnose infection of joint replacements, including the current gold standard C-reactive protein, which offers poor specificity when diagnosing infection in the post-operative period. In the post-operative period these tests are unable to differentiate between physiological inflammation and infection of the replacement. Early treatment through antibiotic and washout therapy is essential to eradicate infection, saving the patient and the NHS the stress of revision surgery, which offers a much poorer prognosis than the original operative procedure. Thus, a superior marker is required and CD64 has been proposed to fulfil the necessary requirements of an effective marker. Data from several studies utilising a flow cytometer support the view that CD64 is firstly, a good marker of systemic infection and secondly, when studied in conjunction with musculoskeletal infections alone, is a sensitive and specific marker of this type of infection. However, meta-analysis of studies in this field concludes that more highly powered studies are needed before definite conclusions can be drawn. Despite this, the studies do portray a strong case for CD64 being the future of diagnosis of post-operative infection.

Impact factors of orthopaedic journals between 2000 and 2010: trends and comparisons with other surgical specialties.

PURPOSE: The impact factors (IF) of orthopaedic journals is an important component in determining the future of orthopaedic research funding. We aim to characterise the trend in journal IF over the last decade and draw comparisons with other surgical specialties. METHODS: We conducted an analysis of impact factors from Journal Citation Reports between 2000 and 2010. RESULTS: Between 2000 and 2010 the number of orthopaedic journals increased from 24 to 41, more than any other surgical specialty and the mean IF increased from 0.842 to 1.400. Journals printed in the English language had a significantly higher IF in the year 2010 (1.64 vs. 0.33, p = 0.01) than those printed in other languages. English language journals published in the US had significantly higher mean 2010 IF (1.932 vs. 1.243, p = 0.025) than those published in Europe, and this had changed compared with 2000 mean IF (0.978 Vs. 0.704, p = 0.360). Orthopaedics was ranked sixth out of 11 surgical subspecialties in 2000 but dropped to seventh out of 11 in 2010. CONCLUSIONS: The quality of orthopaedic journals has significantly increased over the last decade and this has been accompanied by a rise in mean IF. It is important that orthopaedics continues to improve the quality of research, which may help orthopaedic researchers secure funding in the future.

Bio-interference screw cyst formation in anterior cruciate ligament reconstruction--10-year follow up.

PURPOSE: This study used serial MRI to assess the absorption of a poly l-lactide Bioabsorbable interference screw used in the anterior cruciate ligament reconstruction with a 4-strand hamstring technique. METHODS: A consecutive series of ten patients undergoing anterior cruciate ligament reconstruction a 4-strand hamstring technique were assessed with magnetic resonance imaging (MRI) scans at 1, 2, 4, 7 and 10 years postoperatively. RESULTS: No resorption had occurred after 4 years in any of the patients. By 7 years screw absorption was complete in seven patients and had progressed in three. New cyst formation occurred in 3 patients between 5 and 7 years. Half the patients displayed small fluid collections within the tibial tunnels. At 10 years all screws were fully absorbed; however cyst formation was common, including the development of a new cyst in the period between 7 and 10 years in one patient. None of the patients had instability, persistent effusions, or clinically detectable adverse reactions to the screws. CONCLUSIONS: This study has shown that poly l-lactide bioabsorbable screws take longer to resorb than initial in vitro data suggested. It is unclear whether ganglion formation within the tibial tunnel is related to screw resorption or the hamstring graft. The theoretical advantages of bioabsorbable screws must be weighed against these findings.

Cup anteversion in hip resurfacing: validation of EBRA and the presentation of a simple clinical grading system.

The use of large metal on metal bearings has led to a reduction in the risk of dislocation post hip arthroplasty. Because of this, and also because of the technical difficulties associated with resurfacing surgery in particular, it could be argued that a less meticulous approach to acetabular cup placement has developed in comparison with conventional metal on polyethylene arthroplasty. Resurfacing cups may produce significant clinical problems when placed at the extremes of version, including increased production of metal debris and psoas tendonitis. Presented in this article is evidence that EBRA software (Einzel-Bild-Roentgen-Analysis, University of Innsbruck, Austria) can be used to reliably assess the version of resurfacing cups, when radiographs are of sufficient quality. The cups have characteristic appearances when placed at the extremes of version. These characteristics can allow the surgeon to identify poorly positioned cups without the use of software.

A novel in vitro model to investigate behavior of articular chondrocytes in osteoarthritis.

OBJECTIVE: To investigate in vivo simulation of the microenvironment in which osteoarthritis (OA) chondrocytes are cultured in vitro. METHODS: Human articular chondrocytes were cultured under normoxic and hypoxic conditions. Cells were cultured on standard culture plastic or a porous polyHEMA surface that closely resembles the in vivo cartilage microarchitecture. Morphological changes to the cells were demonstrated by fluorescent staining with DAPI and vinculin. Proteoglycan and type II collagen protein levels were assessed using established techniques. Matrix metalloproteinase-1 (MMP-1) production was assessed by ELISA. The gene expression of type II collagen and SOX9 was measured using real-time polymerase chain reaction. RESULTS: Cells grown on culture plastic were seen to be flat and hexagonal. Cells cultured on the porous polyHEMA surface exhibited morphology in keeping with the in vivo microenvironment. Glycosaminoglycan release in hypoxia was high from cells cultured on standard culture plastic. Transcriptional expression of type II collagen was upregulated in hypoxia and by culture on the polyHEMA surface. Transcriptional expression of SOX9 in hypoxia was upregulated compared to normoxia; no significant effect was seen by varying the culture surface. Translational expression of type II collagen was upregulated at 20% oxygen on the polyHEMA surface compared to culture plastic and this was related to MMP-1 expression. CONCLUSION: Culture of chondrocytes in hypoxia and on a porous surface simulates the in vivo microenvironment and illustrates the molecular mechanisms of OA.

ASARM-truncated MEPE and AC-100 enhance osteogenesis by promoting osteoprogenitor adhesion.

Matrix extracellular phosphoglycoprotein (MEPE) is a member of the SIBLING (Small Integrin-Binding Ligand, N-linked Glycoprotein) family of secreted glycophosphoproteins. Several previous studies have demonstrated that MEPE and its peptide motif, AC-100, may regulate bone mass and influence osteoblast activity, suggesting its potential for inclusion in novel therapeutic strategies aimed at increasing osteogenesis. Our study uses in vitro approaches to assess how adhesion of nonadherent cells is influenced by MEPE and whether response to MEPE is dependent on the maturity of osteoblastic cells. Truncated MEPE (ASARM removed) or AC-100 enhanced the adhesion, spreading, and focal complex formation of unadhered osteoblastic cells leading to increased differentiation and bone formation after 28 days of culture. Furthermore, addition of truncated MEPE or AC-100 to mature osteoblasts had no significant effect on bone formation. Our data supports an action for truncated MEPE and AC-100 in altering the physiology of immature poorly adherent cells which subsequently influences the way in which these cells interact with a substrate to facilitate their survival and/or commitment to the osteoblast lineage.