Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

BACKGROUND: The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals. METHODS: Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instructions for authors of the highest impact general orthopaedic journals. Based upon a priori eligibility criteria, two assessors hand searched all issues of the eligible journal from 2003–2004 for RCTs. The assessors extracted the demographic information and the evidence rating from each included RCT and scored the quality of reporting using the reporting quality assessment tool, which was developed by the Cochrane Bone, Joint and Muscle Trauma Group. Scores were conducted in duplicate, and we reached a consensus for any disagreements. We examined the correlation between the level of evidence rating and the Cochrane reporting quality score. RESULTS: We found that only the Journal of Bone and Joint Surgery – American Volume (JBJS-A) used a level of evidence rating from 2003 to 2004. We identified 938 publications in the JBJS-A from January 2003 to December 2004. Of these publications, 32 (3.4%) were RCTs that fit the inclusion criteria. The 32 RCTs included a total of 3543 patients, with sample sizes ranging from 17 to 514 patients. Despite being labelled as the highest level of evidence (Level 1 and Level II evidence), these studies had low Cochrane reporting quality scores among individual methodological safeguards. The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies. Correlations varied from 0.0 to 0.2 across the 12 items of the Cochrane reporting quality assessment tool (p > 0.05). Among items closely corresponding to the Levels of Evidence Rating System criteria assessors achieved substantial agreement (ICC = 0.80, 95%CI:0.60 to 0.90). CONCLUSION: Our findings suggest that readers should not assume that 1) studies labelled as Level I have high reporting quality and 2) Level I studies have better reporting quality than Level II studies. One should address methodological safeguards individually

Similar risk of complete revision for infection with single-dose versus multiple-dose antibiotic prophylaxis in primary arthroplasty of the hip and knee:results of an observational cohort study in the Dutch Arthroplasty Register in 242,179 patients

Background and purpose - The optimal type and duration of antibiotic prophylaxis for primary arthroplasty of the hip and knee are subject to debate. We compared the risk of complete revision (obtained by a 1- or 2-stage procedure) for periprosthetic joint infection (PJI) after primary total hip or knee arthroplasty between patients receiving a single dose of prophylactic antibiotics and patients receiving multiple doses of antibiotics for prevention of PJI. Patients and methods - A cohort of 130,712 primary total hip and 111,467 knee arthroplasties performed between 2011 and 2015 in the Netherlands was analyzed. We linked data from the Dutch arthroplasty register to a survey collected across all Dutch institutions on hospital-level antibiotic prophylaxis policy. We used restricted cubic spline Poisson models adjusted for hospital clustering to compare the risk of revision for infection according to type and duration of antibiotic prophylaxis received. Results - For total hip arthroplasties, the rates of revision for infection were 31/10,000 person-years (95% CI 28-35), 39 (25-59), and 23 (15-34) in the groups that received multiple doses of cefazolin, multiple doses of cefuroxime, and a single dose of cefazolin, respectively. The rates for knee arthroplasties were 27/10,000 person-years (95% CI 24-31), 40 (24-62), and 24 (16-36). Similar risk of complete revision for infection among antibiotic prophylaxis regimens was found when adjusting for confounders. Interpretation - In a large observational cohort we found no apparent association between the type or duration of antibiotic prophylaxis and the risk of complete revision for infection. This does question whether there is any advantage to the use of prolonged antibiotic prophylaxis beyond a single dose.Orthopaedics, Trauma Surgery and Rehabilitatio

Return to Sports and Physical Activity After Total and Unicondylar Knee Arthroplasty: A Systematic Review and Meta-Analysis

People today are living longer and want to remain active. While obesity is becoming an epidemic, the number of patients suffering from osteoarthritis (OA) is expected to grow exponentially in the coming decades. Patients with OA of the knee are progressively being restricted in their activities. Since a knee arthroplasty (KA) is a well accepted, cost-effective intervention to relieve pain, restore function and improve health-related quality of life, indications are expanding to younger and more active patients. However, evidence concerning return to sports (RTS) and physical activity (PA) after KA is sparse. Our aim was to systematically summarise the available literature concerning the extent to which patients can RTS and be physically active after total (TKA) and unicondylar knee arthroplasty (UKA), as well as the time it takes. PRISMA guidelines were followed and our study protocol was published online at PROSPERO under registration number CRD42014009370. Based on the keywords (and synonyms of) 'arthroplasty', 'sports' and 'recovery of function', the databases MEDLINE, Embase and SPORTDiscus up to January 5, 2015 were searched. Articles concerning TKA or UKA patients who recovered their sporting capacity, or intended to, were included and were rated by outcomes of our interest. Methodological quality was assessed using Quality in Prognosis Studies (QUIPS) and data extraction was performed using a standardised extraction form, both conducted by two independent investigators. Out of 1115 hits, 18 original studies were included. According to QUIPS, three studies had a low risk of bias. Overall RTS varied from 36 to 89% after TKA and from 75 to >100% after UKA. The meta-analysis revealed that participation in sports seems more likely after UKA than after TKA, with mean numbers of sports per patient postoperatively of 1.1-4.6 after UKA and 0.2-1.0 after TKA. PA level was higher after UKA than after TKA, but a trend towards lower-impact sports was shown after both TKA and UKA. Mean time to RTS after TKA and UKA was 13 and 12 weeks, respectively, concerning low-impact types of sports in more than 90 % of cases. Low- and higher-impact sports after both TKA and UKA are possible, but it is clear that more patients RTS (including higher-impact types of sports) after UKA than after TKA. However, the overall quality of included studies was limited, mainly because confounding factors were inadequately taken into account in most studie

Peak incidence of distal radius fractures due to ice skating on natural ice in The Netherlands

An increase of distal radius fractures was seen in 2009 when an extended cold spell allowed natural ice skating in Amsterdam. This resulted in overload of our Emergency Departments and operating rooms. This study reports patient and fracture characteristics of these injuries. We also determined potential skating-related risk factors. All patients who sustained a distal radius fracture during natural ice skating between January 3 and January 12, 2009 were included. Patient and fracture characteristics, treatment, validated outcome (Quick DASH) at 3 months after injury were determined. Natural ice skating accounted for a 5.5-fold increase of distal radius fractures (92 fractures) compared to a similar time period without natural ice skating in 2008. Fracture types were AO-type A, n = 50, type B, n = 11 and type C, n = 31. Twenty-eight patients were casted without reduction. Fifty-four patients underwent at least one reduction before casting. The non-operative group consisted of 67 patients (68 fractures, male/female 18/49) with an average age of 55.5 years. Twenty-three patients (24 fractures) underwent internal fixation. Quick DASH for the whole group was a mean of 23.1 points (range 0–95). The mean Quick DASH for the non-operatively treated group was 19.9 points (range 0–95), for the operatively treated group 31.7 points (range 2–65). Distal radius fractures increased 5.5-fold during a period with natural ice skating. Women aged 50 and over were predominantly affected. Most fractures were extra-articular, and the vast majority was treated non-operatively. Utilization of wrist-protecting devices should be considered during future natural ice periods

Cumulative incidence and treatment of non-simultaneous bilateral femoral neck fractures in a cohort of one thousand two hundred and fifty patients

Purpose In the Netherlands, over 20,000 patients sustain a hip fracture yearly. A first hip fracture is a risk factor for a second,

Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: A meta-Analysis and systematic review of randomized trials

Purpose Displaced femoral neck fractures in healthy elderly patients have traditionally been managed with hemiarthroplasty (HA). Recent data suggest that total hip arthroplasty (THA) may be a better alternative. Methods A systematic review of the English literature was conducted. Randomized controlled trials comparing all forms of THA with HA were included. Three authors independently extracted articles and predefined data. Results were pooled using a random effects model. Results Eight trials totalling 986 patients were retrieved. After THA 4 % underwent revision surgery versus 7 % after HA. The one-year mortality was equal in both groups: 13 % (THA) versus 15 % (HA). Dislocation rates were 9 % after THA versus 3 % after HA. Equal rates were found for major (25 % in THA versus 24 % in HA) and minor complications (13 % THA versus 14 % HA). The weighted mean of the Harris hip score was 81 point

The Harris hip score: Do ceiling effects limit its usefulness in orthopedics?: A systematic review

The Harris hip score (HHS), a disease-specific health status scale that is frequently used to measure the outcome of total hip arthroplasty, has never been validated properly. A questionnaire is suitable only when all 5 psychometric properties are of sufficient quality. We questioned the usefulness of the HHS by investigating its content validity. We performed a systematic review based on a literature search in PubMed, Embase, and the Cochrane Library for descriptive studies published in 2007. 54 studies (59 patient groups) met our criteria and were included in the data analysis. To determine the content validity, we calculated the ceiling effect (percentage) for each separate study and we pooled data to measure the weighted mean. A subanalysis of indications for THA was performed to differentiate the populations for which the HHS would be suitable and for which it would not. A ceiling effect of 15% or less was considered to be acceptable. Over half the studies (31/59) revealed unacceptable ceiling effects. Pooled data across the studies included (n = 6,667 patients) suggested ceiling effects of 20% (95%CI: 18-22). Ceiling effects were greater (32%, 95%CI:12-52) in those patients undergoing hip resurfacing arthroplasty. Although the Harris hip score is widely used in arthroplasty research on outcomes, ceiling effects are common and these severely limit its validity in this field of researc

Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip

Objectives Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial. Design A prospective blinded randomised controlled multicentre trial in patients with osteoarthritis of the hip. All patients, research assistants, clinical assessors, investigators and data analysts were blinded to the type of prosthesis. Population: 150 patients between 18 and 70 years with osteoarthritis of the hip, 75 in the short stem and 75 in the conventional stem group. Mean age: 60 years (SD 7). Interventions: The Collum Femoris Preserving short stem versus the Zweymuller Alloclassic conventional stem. Main outcome measures The Dutch version of the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes measures: Harris Hip Score, the Physical Component Scale of the SF12, the Timed Up and Go test, Pain and the EQ-5D. Feasibility outcomes: continued blinding, protocol adherence and follow-up success rate. Results No significant difference between the two groups. Mean HOOS total score in the short stem group increased 32.7 points from 36.6 (95% CI 32.9 to 40.2) preoperatively to 69.3 (95% CI 66.4 to 72.1) at 3 months follow-up. Mean HOOS total score in the conventional straight stem group increased 36.3 points from 37.1 (95% CI 33.9 to 40.3) preoperatively to 73.4 (95% CI 70.3 to 76.4) at 3 months follow-up. 91.2% of patients remained blinded at 2 years follow-up. Both protocol adherence and follow-up success rate were 98%. Conclusions Functional result at 3 months and 2 years after short stem THA is not superior to conventional cementless THA. There were more perioperative and postoperative complications in the short stem group. Direct comparison of two hip implants in a double-blinded randomised controlled trial is feasible. Trial registration number NTR1560