Background
Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical industry sponsored studies are more often favorable to the sponsor’s product compared with studies with other sources of sponsorship. This review is an update using more stringent methodology and also investigating sponsorship of device studies.

Objectives
To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship.

Search methods
We searched MEDLINE (1948 to September 2010), EMBASE (1980 to September 2010), the Cochrane Methodology Register (Issue 4, 2010) and Web of Science (August 2011). In addition, we searched reference lists of included papers, previous systematic reviews and author files.

Selection criteria
Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions.

Data collection and analysis
Two assessors identified potentially relevant papers, and a decision about final inclusion was made by all authors. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals).

Main results
Forty-eight papers were included. Industry sponsored studies more often had favorable efficacy results, risk ratio (RR): 1.32 (95% confidence interval (CI): 1.21 to 1.44), harms results RR: 1.87 (95% CI: 1.54 to 2.27) and conclusions RR: 1.31 (95% CI: 1.20 to 1.44) compared with non-industry sponsored studies. Ten papers reported on sponsorship and effect size, but could not be pooled due to differences in their reporting of data. The results were heterogeneous; five papers found larger effect sizes in industry sponsored studies compared with non-industry sponsored studies and five papers did not find a difference in effect size. Only two papers (including 120 device studies) reported separate data for devices and we did not find a difference between drug and device studies on the association between sponsorship and conclusions (test for interaction, P = 0.23). Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment and follow-up. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.32 (95% CI: 1.05 to 1.65), compared with non-industry sponsored studies. In industry sponsored studies, there was less agreement between the results and the conclusions than in non-industry sponsored studies, RR: 0.84 (95% CI: 0.70 to 1.01).

Authors' conclusions
Sponsorship of drug and device studies by the manufacturing company leads to more favorable results and conclusions than sponsorship by other sources. Our analyses suggest the existence of an industry bias that cannot be explained by standard 'Risk of bias' assessments.

/pdf/industry-sponsorship-and-research-outcome-1zaeyoxoy7.pdf

Industry sponsorship and research outcome

Background Revision surgery for failed total knee arthroplasty (TKA) continues to pose a substantial burden for the United States healthcare system. The predominant etiology of TKA failure has changed over time and may vary between studies. This report aims to update the current literature on this topic by using a large national database. Specifically, we analyzed: (1) etiologies for revision TKA; (2) frequencies of revision TKA procedures; (3) various demographics including payer type and region; and (4) the length of stay (LOS) and total charges based on type of revision TKA procedure. Methods The Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample (NIS) database was used to identify all revision TKA procedures performed between 2009 and 2013. Clinical, economic, and demographic data were collected and analyzed for 337,597 procedures. Patients were stratified according to etiology of failure, age, sex, race, US census region, and primary payor class. The mean LOS and total charges were also calculated. Results Infection was the most common etiology for revision TKA (20.4%), closely followed by mechanical loosening (20.3%). The most common revision TKA procedure performed was all component revision (31.3%). Medicare was the primary payor for the greatest proportion of revisions (57.7%). The South census region performed the most revision TKAs (33.2%). The overall mean LOS was 4.5 days, with arthrotomy for removal of prosthesis without replacement procedures accounting for the longest stays (7.8 days). The mean total charge for revision TKAs was $75,028.07. Conclusion Without appropriate measures in place, the burden of revision TKAs may become overwhelming and pose a strain on providers and institutions. Continued insight into the etiology and epidemiology of revision TKAs may be the principle step towards improving outcomes and mitigating the need for future revisions.

Current Epidemiology of Revision Total Knee Arthroplasty in the United States

A review of sarcopenia: Enhancing awareness of an increasingly prevalent disease

Background and purpose The effects of patient-related and technical factors on the risk of revision due to dislocation after primary total hip arthroplasty (THA) are only partly understood. We hypothesized that increasing the femoral head size can reduce this risk, that the lateral surgical approach is associated with a lower risk than the posterior and minimally invasive approaches, and that gender and diagnosis influence the risk of revision due to dislocation. Patients and methods Data on 78,098 THAs in 61,743 patients performed between 2005 and 2010 were extracted from the Swedish Hip Arthroplasty Register. Inclusion criteria were a head size of 22, 28, 32, or 36 mm, or the use of a dual-mobility cup. The covariates age, sex, primary diagnosis, type of surgical approach, and head size were entered into Cox proportional hazards models in order to calculate the adjusted relative risk (RR) of revision due to dislocation, with 95% confidence intervals (CI). Results After a mean follow-up of 2.7 (0–6) year...

The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis: An analysis of 78,098 operations in the Swedish Hip Arthroplasty Register

Objective

Most of the evidence regarding complications following total hip arthroplasty (THA) and total knee arthroplasty (TKA) are based on patients with osteoarthritis (OA); less is known about outcomes in rheumatoid arthritis (RA). Using a validated algorithm for identifying patients with RA, we undertook this study to compare the rates of complications among THA and TKA recipients between those with RA and those without RA.



Methods

In patients who underwent a first primary elective THA or TKA between 2002 and 2009, those with RA were identified using a validated algorithm: a hospitalization with a diagnosis code for RA or 3 physician billing claims with a diagnosis code for RA, with at least 1 claim by a specialist (rheumatologist, orthopedic surgeon, or internist) in a 2-year period. Recipients with diagnostic codes suggesting an inflammatory arthritis, but not meeting RA criteria, were classified as having inflammatory arthritis. All remaining patients were deemed to have OA. Cox proportional hazards models, censored on death, were used to determine the relationship between the type of arthritis and the occurrence of specific complications, adjusting for potential confounders (age, sex, comorbidity, and provider volume).



Results

We identified 43,997 eligible THA recipients (3% with RA) and 71,793 eligible TKA recipients (4% with RA). Total joint arthroplasty recipients with RA had higher age and sex–standardized rates of dislocation following THA (2.45%, compared with 1.21% for recipients with OA) and higher age and sex–standardized rates of infection following TKA (1.26%, compared with 0.84% for recipients with OA). Controlling for potential confounders, recipients with RA remained at increased risk of dislocation within 2 years of THA (adjusted hazard ratio [HR] 1.91, P = 0.001) and remained at increased risk of infection within 2 years of TKA (adjusted HR 1.47, P = 0.03) relative to recipients with OA.



Conclusion

Patients with RA are at higher risk of dislocation following THA and are at higher risk of infection following TKA relative to those with OA. Further research is warranted to elucidate explanations for these findings, including the roles of medication profile, implant choice, postoperative antibiotic protocol, and method of rehabilitation following joint replacement.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/art.38231

Increased risk of complications following total joint arthroplasty in patients with rheumatoid arthritis.

Purpose
The joint line of the native knee is horizontal to the floor and perpendicular to the vertical weight-bearing axis of the patient in a bipedal stance. The purposes of this study were as follows: (1) to find out the distribution of the native joint line in a population of normal patients with normal knees; (2) to compare the native joint line orientation between patients receiving conventional mechanically aligned total knee arthroplasty (TKA), navigated mechanically aligned TKA, and kinematically aligned TKA; and (3) to determine which of the three TKA methods aligns the postoperative knee joint perpendicular to the weight-bearing axis of the limb in bipedal stance.

Kinematically aligned TKA can align knee joint line to horizontal

We compared the dislocation rate of total hip arthroplasty between posterior approach and lateral approach in a prospective randomized trial. One hundred ninety-six hips were randomly chosen for a posterior approach with a posterior soft tissue repair (99 hips) or a lateral approach (97 hips). The average duration of follow-up was 37.9 months. Three hips (3%) dislocated in the lateral group, whereas none from the posterior group dislocated. At the final follow-up, the Harris hip score and limping were similar in the 2 groups. The joint stability obtained by the posterior soft tissue repair in the posterior approach group seemed to produce more favorable result when compared to the stability obtained from the lateral approach group.

Dislocation after total hip arthroplasty: a randomized clinical trial of a posterior approach and a modified lateral approach.

Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength due to senescence, which may lead to physical disability, poor quality of life, and even increased mortality.1) The unprecedentedly rapid aging process in Asian countries has drawn much attention to the geriatric condition.1)

Recently, a number of researches have been published on the prevalence and related risk factors of sarcopenia in various cohorts in Asia.2,3,4,5,6,7,8,9) To the best of our knowledge, however, the prevalence of sarcopenia among adults undergoing orthopedic surgery (OS) has never been reported. In the field of OS, bone mineral density (BMD) and bone quality have been the primary focus; however, recent studies have revealed that both bone and muscle are endocrine organs10,11) that are closely associated in both formation and function.12) Moreover, sarcopenia and osteoporosis constitute a hazardous duo that causes frailty in the elderly.13) A recent study has demonstrated the synergistic effects of medications for osteoporosis and mechanical stimuli generated by the muscle, which resulted in the enhanced cortical thickness.14) Such evidence might reveal how sarcopenia adversely affects musculoskeletal health and function in the intraoperative and postoperative settings, especially among the elderly who undergo a number of OS; thus, data on the prevalence of sarcopenia in this population may be invaluable. Moreover, the exact definition of sarcopenia in the orthopaedic field is still debatable, although the European Working Group on Sarcopenia in Older People devised a working clinical definition and consensus-based diagnostic criteria for sarcopenia in 2010.1) According to these criteria, one must have low muscle mass in order to be diagnosed as sarcopenic. However, a variety of methods are currently used to define low muscle mass15,16,17) for orthopedic patients in the absence of any consensus on the ideal criterion of low muscle mass. Recently, the combined impact of muscle loss and fat gain on the functional disability in older persons has been reported,18) and the prevalence of a condition known as sarcopenic obesity has become of great interest.

The purpose of this study was to identify the prevalence of sarcopenia and sarcopenic obesity among adult patients who had common OS of specific types, namely intra- and extracapsular proximal femoral fracture surgery and total hip/knee replacement (THR/TKR) and to compare the prevalence of sarcopenia in them with that in nonorthopedic patients at our and other outpatient departments (OPDs).

/pdf/sarcopenia-and-sarcopenic-obesity-in-patients-undergoing-1g1mtayx9y.pdf

Sarcopenia and Sarcopenic Obesity in Patients Undergoing Orthopedic Surgery

Background: The choice of modalities for thromboprophylaxis after total joint arthroplasty is controversial. To address this issue, an evidence-based review of previous studies was performed. The characteristics of the studies selected for review can affect the final conclusion of an evidence-based review. One such characteristic, financial conflict of interest related to medical research, is a widespread concern. The purpose of the present study was to determine what proportion of studies on thromboprophylaxis after total joint arthroplasty were sponsored by industry and whether the assessments of thromboprophylaxis after total joint arthroplasty were associated with industry support. Methods: We searched PubMed for prospective, original, English-language studies, published from 2004 to 2010, on thromboprophylaxis after total joint arthroplasty. The funding sources of the articles were reviewed, and qualitative conclusions regarding the modality of interest for thromboprophylaxis after total joint arthroplasty were classified as being favorable, neutral, or unfavorable. Results: Seventy-one eligible articles were identified; fifty-two were funded by industry, and fourteen were not. The other five studies did not include information about the funding source. A significant association was observed between the funding source and qualitative conclusions (p = 0.033). Only two (3.8%) of the fifty-two industry-sponsored studies had unfavorable conclusions, whereas three (21.4%) of the fourteen non-industry-sponsored studies indicated that, depending on the clinical scenario, the modality examined was neither effective nor safe. Conclusions: Most studies on thromboprophylaxis after total joint arthroplasty are sponsored by industry. Moreover, the qualitative conclusions in those studies are favorable to the use of the sponsored prophylactic agent.

/pdf/conflict-of-interest-in-the-assessment-of-thromboprophylaxis-1cn6w7zo1n.pdf

Hyung-Min Ji

Papers

Kinematically aligned TKA can align knee joint line to horizontal

Dislocation after total hip arthroplasty: a randomized clinical trial of a posterior approach and a modified lateral approach.

Sarcopenia and Sarcopenic Obesity in Patients Undergoing Orthopedic Surgery

Conflict of interest in the assessment of thromboprophylaxis after total joint arthroplasty: a systematic review.

Transcriptional profiling of human femoral mesenchymal stem cells in osteoporosis and its association with adipogenesis.