Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label Rheumatoid Arthritis. Show all posts
Showing posts with label Rheumatoid Arthritis. Show all posts

Friday, November 22, 2013

Huzzah! Canadian Patient Outcomes Research on Joint Replacement: U.S. PCORI=none?



 Published: Nov 21, 2013
 By Nancy Walsh, Staff Writer, MedPage Today
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania

 Action Points
         Note that this large cohort study of Canadian recipients of hip or knee replacements demonstrated higher complication rates among those with rheumatoid arthritis compared with those with osteoarthritis.
         Be aware that there may be unmeasured confounders that could affect the interpretation of these results -- for example the degree of immunomodulatory therapy received by the RA group.

Patients with rheumatoid arthritis were at higher risk than those with osteoarthritis for adverse outcomes following joint replacement surgery, a Canadian study found.
After adjustment for potential confounders, having a diagnosis of rheumatoid arthritis was a significant and independent predictor of dislocation following total hip arthroplasty, with a risk almost double that for osteoarthritis (HR 1.91, 95% CI 1.29-2.82, P=0.001), according to Bheeshma Ravi, MD, of the University of Toronto, and colleagues.
Patients with rheumatoid arthritis also were at greater risk for developing an infection after total knee arthroplasty (HR 1.52, 95% CI 1.11-2.09, P=0.03), the researchers reported online in Arthritis & Rheumatism.
"Over the last decade, the age-sex standardized rates of total hip arthroplasty and total knee arthroplasty have increased in North America by approximately 25% and 65%, respectively," wrote Ravi and colleagues.
These surgeries have been linked with a risk -- albeit small -- for serious complications including dislocation, infection, venous thromboembolism, and even death.
However, most data on these complications have been drawn from the patient population with osteoarthritis, and little is known about risks for those with rheumatoid arthritis, a much different disease in its causes, prognosis, and treatment.
The researchers previously conducted a systematic review and meta-analysis in an effort to fill this knowledge gap, but were hampered by limitations in many studies such as the possibility of diagnostic misclassification and lack of adjustment for confounders.
Therefore, they undertook a study in which they analyzed data from the Canadian Institute for Health Information Discharge Abstract Database, identifying patients with a primary elective hip or knee replacement between April 2002 and March 2009.
The diagnosis of rheumatoid arthritis was confirmed using an algorithm that necessitated hospitalization with a diagnostic code specifically for rheumatoid arthritis or three physician claims, at least one being from a specialist such as a rheumatologist or orthopedic surgeon, within the previous 2 years.
This validated algorithm has a specificity of 100% and a sensitivity of 78%.
The researchers adjusted for patient age, gender, income, residence, and comorbidities such as congestive heart failure and diabetes.
They also controlled for frailty, which has been linked with loss of muscle strength and immune system abnormalities and therefore could contribute to dislocation and infection.
During the study period, there were 89,713 knee and 60,305 hip arthroplasties performed in Ontario. A total of 3% of the hip replacements and 4% of the knee surgeries were in patients with rheumatoid arthritis.
Compared with recipients with osteoarthritis, those with rheumatoid arthritis were younger, more often women and frail, and had more comorbidities.
They also were more likely to have any type of complication following surgery (5.7% versus 4.7%, P=0.01), but less likely to develop venous thromboembolism (HR 0.35, 95% CI 0.15-0.82, P=0.02).
The lower risk for venous thromboembolism was unexpected, according to the researchers, and may reflect selection bias.
Among all patients experiencing a dislocation within 2 years, the median time to the event was 211 days for rheumatoid arthritis compared with 263 days for osteoarthritis.
And among those who developed articular infections, the median time to the event was 196 days for rheumatoid arthritis compared with 468 days for osteoarthritis.
The researchers noted that dislocation within a short time of total hip arthroplasty is a "serious complication."
"In addition to being very painful and necessitating revision arthroplasty and/or aggressive rehabilitation following closed reduction, it is estimated that dislocations increase the hospital costs of a primary total hip arthroplasty by over 300%," they observed.
Possible reasons why patients with rheumatoid arthritis were more likely to experience this complication were the use of smaller implants and different surgical techniques, along with disease-related factors such as acetabular protrusion and soft tissue problems.
Explanations for why infections were more common in the rheumatoid group included the use of immunomodulatory treatments, but it wasn't clear why the increased risk was only for knee replacement and not also for the hip.
Strengths of the study included the specificity of the algorithm used for diagnosis and large patient population, while limitations were the lack of information about the specific implants used and the possibility of unmeasured confounders.
"As both dislocation and infection lead to significant morbidity and drastically increase healthcare costs, research is warranted to elucidate explanations for this increased risk among patients with rheumatoid arthritis. This information will be valuable to inform patient management decisions, including the development and implementation of strategies designed to target modifiable risk factors," Ravi and colleagues concluded.
The study was supported by the Canadian Institutes of Health Research.
The authors reported no conflicts of interest.

Primary source: Arthritis & Rheumatism
Source reference: Ravi B, et al "Patients with rheumatoid arthritis are at increased risk for complications following total joint arthroplasty" Arthritis Rheum 2013; DOIi: 10.1002/art.38231.



Wednesday, December 5, 2012

Rheumatoid Arthritis Study: Hip, Knee Replacement


http://www.emaxhealth.com/11306/caution-advised-rheumatoid-arthritis-patients-considering-hip-or-knee-replacement


By Robin Wulffson Md on November 30, 2012 - 5:26pm  for eMaxHealth
                Arthritis Pain Treatment Current News


Victims of rheumatoid arthritis can develop problems with their joints throughout the body, including the knee and hip. These joints can be replaced with an artificial one with a procedure known as arthroplasty. Researchers affiliated with the University of Toronto (Toronto, Ontario, Canada) conducted a study to evaluate the complication rate of a total hip or knee arthroplasty among patients with rheumatoid arthritis, compared to patients with osteoarthritis. They published their findings online on November 28 in the journal Arthritis & Rheumatism.
The researchers noted that most of the evidence regarding complications following total hip arthroplasty and total knee arthroplasty is based on studies of patients with osteoarthritis; thus, little information regarding the outcomes in patients with rheumatoid arthritis has been published. Therefore, they conducted a study with the objective of reviewing the current evidence regarding rates of total hip and knee arthroplasty complications in rheumatoid arthritis patients compared to osteoarthritis patients.
The researchers reviewed data from Medline, EMBase, Cinahl, Web of Science, and reference lists of articles. They included reports published between 1990 and 2011 that described studies of primary total joint arthroplasty of the hip or knee and contained information on outcomes in 200 or more rheumatoid arthritis and osteoarthritis joints. Outcomes of interest included revision, hip dislocation, infection, 90-day mortality, and venous thromboembolic (blood clot) events. Two reviewers independently evaluated each study for quality and extracted data. Where appropriate, meta-analysis was performed; if this was not possible, the level of evidence was assessed qualitatively.
The review comprised 40 studies. The investigators found that patients with rheumatoid arthritis are at increased risk of dislocation following a total hip arthroplasty (2.16 times greater risk). In addition, the found fair evidence to support the concept that risk of infection and risk of early revision following total knee arthroplasty are increased in rheumatoid arthritis, compared to osteoarthritis. There was no evidence of any differences in rates of revision at later time points, 90-day mortality, or rates of venous thromboembolic events following total hip replacement or total knee replacement in patients with rheumatoid arthritis versus osteoarthritis. Rheumatoid arthritis was explicitly defined in only three studies (7.5%), and only 11 studies (27.5%) included adjustment for covariates (i.e., age, sex, and comorbidity
The researchers concluded that the findings of their literature review and meta-analysis indicate that, compared to patients with osteoarthritis, patients with rheumatoid arthritis are at higher risk of dislocation following total hip arthroplasty and higher risk of infection following total knee arthroplasty.
Arthritis is inflammation of one or more joints, which results in pain, swelling, stiffness, and limited movement. There are over 100 different types of arthritis. Rheumatoid arthritis is considered an autoimmune disease. The body's immune system normally fights off foreign substances, such as viruses. But in an autoimmune disease, the immune system confuses healthy tissue for foreign substances. As a result, the body attacks itself. Osteoarthritis is related to aging. In osteoarthritis, the cushioning (cartilage) between the bones wears away in the joints. As osteoarthritis gets worse, the cartilage disappears and bone rubs on bone. Bony spurs or growths usually form around the joint. The ligaments and muscles around the joint loosen and become weaker.