ORTHO NEWS

While most osteoarthritis patients welcome the pain relief that comes with total knee replacement, some also experience psychological impacts that aren’t so pleasant.

“My leg feels like it’s made of lead,” one patient told a research group led by Andrew Moore, BSc, PhD, of the University of Bristol in England.

“It feels like someone is holding your knees, when you move, it’s like someone is … putting pressure there,” said another. And, said a third: “I know it’s not my knee. It’s an alien knee in there. I don’t really feel connected to it.”

Those were just some of the reactions Moore and colleagues elicited for a study now published in Arthritis Care & Research, meant to explore patients’ thoughts about their artificial implants. They interviewed 34 patients undergoing total knee replacement at two British referral hospitals, asking a semi-structured series of questions about pain and, importantly, other types of discomfort.

The researchers’ goal was to fill what they saw as a major gap in the literature on joint replacement: why some patients say they’re unhappy with the outcome despite reporting less pain and better function.

“Typically, the assessment of patient-reported outcomes after joint replacement focuses on functional outcome and pain relief as the main determinant of satisfaction,” Moore and colleagues explained. “This narrow perspective is compounded by poor definitions of satisfaction after surgery, and there is little research on how and why some patients express dissatisfaction with joint replacement and what they are dissatisfied about.”

Citing a study of hand surgery patients in which patients “spoke about their hand as if it were an object separate from their self,” Moore and colleagues argued that a psychological concept called embodiment could help explain the dissonance.

“Embodiment refers to the experience of the body as both subject and object, such that this idea impacts the way in which a person sees and interacts with the world, and vice versa,” the group wrote. “Embodiment provides a way of understanding how one experiences limits of possible action, a sense of control, and empowerment over physical action.”

Moore and colleagues hadn’t planned to look specifically at embodiment, but, they explained, “by the third interview we noted that some participants described sensations of discomfort such as heaviness or numbness when discussing pain and some described their knee as ‘alien,’ ‘foreign,’ or ‘not part of’ themselves. In response to these findings, the interviewer sought to elicit views about any such sensations in subsequent interviews, if this topic was not broached first by the participant.”

Their study emerged from an earlier one focusing on reasons for avoiding healthcare encounters post-surgery and involved the same participants: patients undergoing total knee replacement at least 1 year and as much as 5 years previously for whom initial screening indicated some degree of lingering pain or discomfort. The semi-structured interview dealt with pain (duration, timing, and other characteristics) as well as how patients managed it. After that third interview, patients who reported feelings of alienation from their implant were asked about it in more detail.

Participants were generally typical of the general knee-replacement population — mostly in their 60 and 70s, and just over half were women. Of the 34 patients, 24 were between 2 and 4 years out from their surgery.

Physical types of non-pain discomfort were commonly reported. These included feelings of numbness and/or heaviness, as well as sensations of pressure applied externally. One man said it felt like the skin over his knee was very tight. Separate from these sensations were reports that the limb no longer felt like a part of them but something foreign like an external prosthesis. Some patients complained that they weren’t always able to control the knee. “That knee just wouldn’t do what it’s told to do,” one told the interviewer.

In a similar vein, another participant said, “If I was to walk across there now and…because [of the dog] on the floor, whereas any normal person would walk along and step over him, I have to stop and think about stepping over him. My knee won’t let me do that.”

Others said they hadn’t regained trust that the knee would work properly. One man said he continues to use a cane, which by normal criteria he shouldn’t need, because of an overwhelming fear of falling.

Overall, according to Moore and colleagues, the reports were very similar to those from amputees discussing their prosthetic limbs. One reason for these reactions may have to do with patients’ lives before the joint replacement, which was often dominated by years of mounting pain and loss of functional ability.

“Presurgical chronic pain, instability, and untrustworthiness might continue to influence [mental] incorporation of the prosthesis afterwards,” the researchers suggested.

And there is a potential clinical implication for the findings: “Our study suggests that the interest for rehabilitation becomes not only strengthening the joint and promoting full recovery to tasks, but also modifying a person’s relationship with the new joint to achieve full incorporation or re-embodiment.”

Programs developed for other conditions, including use of external prosthesis as well as complex regional pain syndromes, may be helpful in this regard, Moore and colleagues offered.

“Our focus should not be on the absence or loss of embodiment,” the researchers added, “but on employing a multidisciplinary approach to using the concept to guide the development of pre-rehabilitative strategies and appropriate outcome measures.”

Medical device company Exactech has recalled hundreds of thousands of joint implants due to concerns that their polyethylene liners could degrade early and cause health complications. The first Exactech recall occurred in August 2021 and only included certain implants, but the manufacturer later expanded and recalled all ankle and knee implants produced after 2004. 

Joint replacement surgery is one of the most common procedures in the U.S., with more than a million surgeries performed yearly. During the surgery, an orthopedic surgeon removes damaged cartilage and bone and replaces them with a prosthetic piece made of metal, plastic, or ceramic. For people with arthritis and joint injuries, the procedure reduces pain and dramatically improves their quality of life. When a joint implant is recalled, these patients wonder whether they’ll be negatively affected.

The success rate for joint replacement surgery varies. Patients often need revision surgery within 10 to 20 years of the procedure, and the follow-up procedure is more complicated and has more risks than the original surgery. The manufacturer found that the Exactech joint replacement parts degraded quickly because of a packaging issue. The device’s polyethylene liners were exposed to too much oxygen, making revision surgery necessary much earlier than expected. 

Decreased joint function, pain, and swelling are telltale signs of joint implant failure. Not every Exactech recalled implant requires a second joint replacement surgery, but if it does, it can take several hours and require more specialized care. It has complications and risks like pulmonary embolisms, nerve damage, infection, and ossification.

Companies must notify consumers about medical implant device recalls, but customers might miss those advisories for various reasons — a change in address, a delay in a notification from the manufacturer, or not understanding that the recall might include their product or device. If you have an Exactech implant and haven’t had any complications, doctors don’t recommend getting it removed preemptively. But it’s still important to know whether you’re potentially affected by the recall, especially if you develop health problems. If you’re wondering whether your Exactech hip, knee, or ankle replacement implant is included in the recall, there are a few ways to find out.

Visit The Exactech Recall Website

First, you should gather details about your joint implant. Your medical records will include the precise implant you received along with the device’s serial number. You can then cross-reference this information on Exactech’s website, which has a comprehensive list of all the implants included in the recall. The searchable database consists of the product line, specific brand name, and the number of units affected. The company also has a telephone hotline for patients with questions about the recall. You’ll have the option to file a claim with Exactech for any out-of-pocket expenses caused by implant damage. However, it’s important to know that filing an Exactech lawsuit is a viable option and can lead to more compensation than settling with the company upfront.

Talk To Your Orthopedic Surgeon About Your Exactech Implant

The surgeon who operated will be able to answer questions about your Exactech implant and whether you should be concerned. Doctors must note an implant’s manufacturer, lot number, and serial number before using it during surgery. Even if your physician is no longer practicing or you’re no longer a patient of theirs, your medical records should be on file. If you do find out you have a recalled Exactech implant, telling your orthopedic surgeon is necessary. They’ll help you determine what warning signs you should look out for that may indicate joint implant failure.

Consult the FDA Database for Exatcech Implant Recalls

The FDA monitors the situation when a product is discovered to be defective. A company has the option to recall a product voluntarily, as Exactech did. If the manufacturer refuses, the FDA can force a recall. The administration has a Medical Device Recalls Database that includes detailed information about Exactech products, including serial numbers and the reasons given by the company for each recall. The government acts as an unbiased third-party source for consumers who want information about product recalls.

If you have an Exactech implant and are affected by product recalls, it’s essential to talk to an attorney before accepting any settlement offer from the company. Joint implant failure is a serious issue that can affect your earning potential and overall quality of life and cause needless pain and suffering. A lawyer will be able to help you explore your legal options and determine the best route to get the compensation you need.

FOSTER CITY, Calif., April 8, 2022 /PRNewswire/ — OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the Company and its collaborators present clinical data strongly supporting joint bone shape change as part of a surrogate marker predictive of joint replacement in knee osteoarthritis (OA) patients.

An abstract entitled, “Improved WOMAC Physical Function is Associated with Slowed Pathological Bone Shape Change after TPX-100: Towards a Surrogate Marker for Virtual Knee Replacement?” was presented today in a Plenary Session of 2022 OARSI World Congress on Osteoarthritis in Berlin, Germany (Abstract 26 in Osteoarthritis and Cartilage Vol. 30 Suppl. S28–S29).

Functional impairment is a key risk factor for knee replacement even after adjusting for knee pain severity, based on the large NIH-sponsored Multicenter Osteoarthritis Study (the “MOST” study) involving over 5,500 knees. In the TPX-100-5, a Phase 2 study, placebo-treated knees with more advanced pathological joint bone shape change at baseline showed much faster progression of pathological bone shape change and poorer knee function at the end of the 12-month study period. In marked contrast, TPX-100-treated knees demonstrated reduction in pathological bone shape change and robust improvement of knee function through 12 months, regardless of severity at baseline. Consequently, both clinical (knee function) and structural (bone shape) efficacies of TPX-100 as compared to placebo were confirmed including in subjects with moderate to severe knee OA.

“The current FDA draft guidance indicates that a positive effect on an imaging marker of OA must be associated with avoidance or delay of the need for joint replacement, or must persuasively reduce deterioration of function and worsening of pain. This is a high bar,” commented Dr. Dawn McGuire, OrthoTrophix’ Chief Medical Officer. “However, the Multicenter Osteoarthritis Study findings and our clinical data collectively suggest that concordant improvements of bone shape change and clinical function could lead to a delay or elimination of the need for joint replacement surgery. These combined outcomes in structure and function could provide a ‘virtual joint replacement’ measure for the study of disease-modifying agents in individuals afflicted with knee OA.”

The Company also will present an abstract entitled, “Intra Articular TPX-100 Significantly Improves Pain Measures and Slows Pathological Bone Shape Chage in Knee OA”. This presentation demonstrates clinically meaningful improvements in overall knee pain and in specific key pain parameters in moderate to severe knee OA, linked to significant reductions in pathological bone shape change (Abstract 254 in Osteoarthritis and Cartilage Vol. 30 S193).

About OrthoTrophix, Inc.
OrthoTrophix, Inc., based in the San Francisco Bay Area, California, is a privately held biopharmaceutical company focused on development and commercialization of a first-in-class Disease Modifying Osteoarthritis Drug (DMOAD). Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage and underlying bones in the knee and other joints with its novel proprietary compounds.

This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. OrthoTrophix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect OrthoTrophix’ business.

Company Contact
Yoshi Kumagai
President and CEO
Tel: (510) 488-3824

SOURCE OrthoTrophix, Inc.

Depending on what you do for a living, it’s very likely that your job is highly stressful. Your entire day could be spent performing repetitive motions such as lifting heavy objects or moving around. It’s essential to take care of your body’s muscles, joints, and nerves before things get worse.

An orthopedic surgeon specializes in the health of the musculoskeletal system and can help you figure out what’s wrong and how to fix it. For those who aren’t familiar with orthopedists, here are a few things to keep in mind when deciding whether or not to see one:

Having Difficulty Climbing the Stairs 

Joints in the knees and hips naturally begin to deteriorate with age, which typically makes it too uncomfortable for the affected body parts to continue functioning normally. If you have trouble walking, climbing stairs, or getting out of chairs, it may be time for your doctor to propose that you have joint surgery. 

Joint injury can manifest itself in various ways, one of which is chronic pain that lasts for more than six months and disrupts daily life. A joint replacement may be necessary for a variety of reasons, including accidents that may have occurred in the past and years of heavy use. 

Instability Of Joints. 

Destabilization is merely one more compelling argument in favor of seeking the counsel and expertise of an orthopedic physician. Should people who have trouble standing, walking, or moving easily investigate the possibility that they have orthopedic problems? Many of them do. The easiest method to go about doing this is to seek the advice of a specialist who is already working in the sector. 

Having a Hard Time with Chores. 

The capacity to carry out daily activities without the assistance of another person is referred to as self-sufficiency. To accomplish this, you must be able to get out of bed with only minimal assistance, dress, bend over to tie your shoes, prepare your meals, and so on. 

Consult AOA Orthopedic Specialists if you are unable to execute the tasks at hand without experiencing significant discomfort or if the manner in which you are expected to carry them out is undergoing significant change. 

Disturbances in Bowel Movement and Bladder Function 

If you find yourself rushing to the bathroom or sitting on the toilet for hours at a time, which is neither pleasant nor normal, it may be time to consult a doctor. Both irritable bowel syndrome (also known as IBS) and nerve injury can have adverse effects on the intestines, the bladder, and the back. 

Irritable bowel syndrome (IBS) can cause abdominal cramping and extreme stool, both of which are indicators that your bowel system isn’t functioning correctly. This can lead to problems in the lower back. On the other hand, injury to the nerves in the back can lead to discomfort in the abdomen and make digestion difficult. 

Bottom Line

You put yourself in jeopardy of long-term damage and impairment if you ignore what your body is trying to tell you. There are several warning signs that should prompt a person to seek medical attention, particularly from an orthopedic specialist. These warning signs include problems with the joints and bones.

Declines in body mass index (BMI) were linked with slower worsening of knee osteoarthritis (OA), according to data from three large longitudinal cohort studies.

With more than 6,000 knees evaluated for OA progression and 4 to 5 years of follow-up, “each 1-unit decrease in BMI was associated with a 4.76% reduction … in the odds of the incidence and progression of the overall structural defects of knee osteoarthritis” as assessed under the Kellgren-Lawrence grading system, reported Zubeyir Salis, BEng, of the University of New South Wales in Kensington, Australia, and colleagues in Arthritis & Rheumatology.

While such a relationship seems obvious, it has evaded firm proof, the researchers noted. Earlier studies had tied body weight to risk of OA development and the likelihood of progression and end-stage outcomes such as total joint replacement. But whether losing or gaining weight alters the trajectory over time is another matter.

Salis and colleagues identified just one previous attempt to address the question directly: patients already showing joint degeneration who lost around 10 kg (22 lb) on average in a randomized diet-and-exercise trial showed no less progression than a control group with little weight loss, but follow-up only lasted 18 months. (A number of other studies had lumped patients without structural damage at baseline together with those with established degeneration, and they had mixed results.)

For the current analyses, Salis and colleagues combined data from three independent cohort studies from the U.S. and the Netherlands: the Osteoarthritis Initiative (OAI), which was also the basis for some of the above-mentioned studies; the Multicenter Osteoarthritis Study (MOST); and the Cohort Hip and Cohort Knee (CHECK) study. These data covered 9,683 knees (5,774 individual patients) for assessing the incidence of structural knee degeneration (i.e., no evidence of joint damage at baseline) and 6,074 knees (3,988 individuals) for progression of established degeneration.

Structural joint parameters were measured with x-rays at baseline and at follow-up, which was 4 years in the OAI and 5 years in the other two cohorts. Changes in these parameters (medial and lateral joint space narrowing and femoral and tibial surface osteophytes) were correlated against changes in BMI.

For patients included in the evaluation of new-onset structural damage, mean age at baseline was 60; about 40% were men and 88% were white. BMI at baseline averaged 28.2, with 33% of participants classified as obese (BMI ≥30). A total of 1,101 participants in this analysis saw BMI declines of at least 1 unit during follow-up, whereas 1,611 had increases of 1 or more units.

Patients’ baseline characteristics in the study of progression were similar. Baseline BMI was a bit higher on average (30.4), and 48% were obese. BMI declines of 1 or more units were seen in 798 participants, while 1,008 had increases.

Salis and colleagues found a significant association between BMI changes and the risk of developing structural damage, with an odds ratio of 1.05 (95% CI 1.02-1.09) for each 1-unit increment in BMI. This value was nearly identical to that seen for risk of progression in patients with damage at baseline (OR 1.05, 95% CI 1.01-1.09). In both analyses, joint space narrowing in the medial area largely drove the overall findings, with odds ratios in both cases of 1.08 per 1-unit BMI increment.

However, the results suggested that weight loss was far from the only factor at play in governing joint-damage incidence and progression. The researchers estimated population-attributable fractions of the total risk accounted for by weight loss at 13% for incidence and 10% for progression.

In addition, the investigators stopped short of asserting that the findings prove that weight loss slows OA disease progression, saying they “showed evidence of association, not causality.” But the researchers did argue that “people with overweight or obesity — and potentially also those of normal weight — may benefit from a decrease in BMI to prevent, delay or slow the structural defects in knee osteoarthritis.”

ROSEMONT, Ill., Nov. 12, 2021 /PRNewswire/ –The American Joint Replacement Registry (AJRR), the cornerstone of the American Academy of Orthopaedic Surgeons (AAOS) Registry Program, released its 2021 Annual Report on hip and knee arthroplasty procedural trends, and patient outcomes today at the American Association of Hip and Knee Surgeons’ (AAHKS) 2021 Annual Meeting. Despite the disruption to the delivery of joint replacement care during the initial impact of the COVID-19 pandemic (March through May 2020), procedures rebounded to historic averages by June 2020. Even with the temporary decline in procedures, the report demonstrates an overall cumulative procedural volume growth of 18.3% compared to the previous year and includes findings from 2,244,587 hip and knee arthroplasty procedures performed between 2012 and 2020.

“The ability to return to normal procedural volume rates just a few months after the COVID-19 pandemic began is a testament to the commitment and resiliency of healthcare institutions, clinicians and patients,” said Bryan D. Springer, MD, FAAOS, chair of the AJRR Steering Committee. “While we are experiencing unprecedented times in healthcare and continue to navigate the challenges of the pandemic, the AJRR remains committed to the growth and expansion of the registry to paint a more complete picture of our patient population. Through increased participation and a successful integration of Medicare claims data, we are providing orthopaedic surgeons, hospitals and stakeholders with actionable data, insights and trends to improve the lives of millions of Americans who suffer from hip and knee arthritis.”

AJRR is the largest orthopaedic registry in the world based on annual procedures submitted, and the 2021 AJRR Annual Report marks the eighth annual report. With the collection and reporting of U.S. hip and knee arthroplasty data, the report aims to provide valuable information to orthopaedic surgeons, hospitals, ambulatory surgery centers, private practices, device manufacturers, payers, and most importantly patients. The 2021 report represents over 2.2 million hip and knee procedures from over 1,150 hospitals, ambulatory surgery centers (ASCs), and private practice groups submitting data from across all 50 states and the District of Columbia.

James A. Browne, MD, FAAOS, chair of the AJRR Publications Subcommittee and editor of AJRR Publications added: “This year’s AJRR Annual Report provides the most comprehensive picture to date of patterns of hip and knee arthroplasty practice and outcomes in the United States. For the first time this year, cumulative percent revision curves were produced with a diagnosis-specific endpoint examining revision due to infection for total knee arthroplasty (TKA) and revision due to periprosthetic fracture for total hip arthroplasty (THA) patients over 65 years of age. The registry continues to use more sophisticated and detailed survivorship curves, including device-specific cumulative revision stratified by bearing and fixation type, in addition to utilizing Centers for Medicare & Medicaid Services (CMS) data.”

Additional findings from the 2021 AJRR Annual Report include:

• Device-specific revision analyses showed that all included hip device constructs had a cumulative percent revision of less than 2.8% at one year and less than 4.7% at final follow up for each respective device. All knee device constructs included in analysis had a cumulative percent revision of less than 2.5% at three years and less than 3.7% at final follow up for each respective device.  
• The use of cement for femoral component fixation is slowly increasing for both elective primary THA as well as arthroplasty for femoral neck fracture, and cementless fixation shows a statistically significant reduction in early revision due to periprosthetic fracture, compared to cementless fixation in elective primary THA patients over 65 years of age.
• While cemented fixation for TKA still predominates, the report shows that cementless fixation continues to increase and was associated with significantly less revision due to infection in elective primary TKA patients over 65 years of age.
• For both TKA and THA procedures, postoperative length of stay continues to decrease.

Enhanced Registry capabilities offerings and include:

• Additional opportunities for sites to track performance measurements and use Registry data in national quality improvement (QI) programs.  
• A 39% increase in sites reporting patient-reported outcome measures (PROMs), compared to the previous year, through continued support of the RegistryInsights® PROM platform and partnerships with third-party vendors with the expanded Authorized Vendor Program.
• Peer-reviewed publications and presentations based on AJRR Registry data.

To read and download the complete 2021 report, visit the AJRR website. Slides with figures and data tables as featured in the report are also available.

AAOS Registry Program 
The AAOS Registry Program’s mission is to improve orthopaedic care through the collection, analysis, and reporting of actionable data. The American Joint Replacement Registry (AJRR), the Academy’s hip and knee replacement registry, is the cornerstone of the AAOS’s Registry Program, and the world’s largest national registry of hip and knee joint replacement data by annual procedural count, with more than 2.4 million procedures contained within its database. Additional registries include the Fracture & Trauma Registry, the Musculoskeletal Tumor Registry (MsTR), the Shoulder & Elbow Registry (SER), and the American Spine Registry (ASR), a collaborative effort between the American Association of Neurological Surgeons (AANS) and the AAOS. 

About the AAOS
With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments, and related musculoskeletal health care issues, and it leads the health care discussion on advancing quality.

Follow the AAOS on Facebook, Twitter, LinkedIn, and Instagram.

SOURCE American Academy of Orthopaedic Surgeons

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