Validity of Non-English PROMs to Assess TKA
Patient-reported outcome measures (PROMs) have become increasingly important tools in the 30 years since the orthopaedic community began embracing the movement toward the “patient perspective.” Clinical findings such as range of motion and imaging results remain important, but we have come to understand that pain and function–as reported by the patient–are the most crucial data points. And we are not alone. Insurance companies, registries, scholarly publications, and research review panels now often require PROMs as part of their core evaluations.
But not all PROMs are created equal. For clinicians to trust the output from these instruments, validation of the measures is required. This entails reliability testing and assessment of face, construct, and criterion validity. Furthermore, translating PROMs validated in English into other languages involves not only linguistic translation, but also cultural components in order to capture the full patient perspective.
In the August 5, 2020 issue of The Journal, Bin Sheeha et al. report their work in evaluating the responsiveness, reliability, and validity of the Arabic-language version of the Oxford Knee Score (OKS-Ar). After painstaking statistical analysis of OKS-Ar questionnaires completed by 100 Arabic-speaking patients (80 of whom were female) before and after total knee arthroplasty (TKA), the authors concluded that the OKS-Ar is a valid, sensitive, and easy-to-use instrument to assess pain and function in TKA-treated individuals whose main language is Arabic.
To be truthful, this is not very glamorous research to conduct or very exciting to read about. However, it is absolutely fundamental to ensuring the validity of multicenter, international trials and registry studies. In essence, Bin Sheeha et al. have dug a conduit that facilitates the flow of reliable data and that will help improve future patient care worldwide. As such, it deserves our attention, understanding, and appreciation.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
Owning the Bone in Spine Surgery
This post comes from Fred Nelson, MD, an orthopaedic surgeon in the Department of Orthopedics at Henry Ford Hospital and a clinical associate professor at Wayne State Medical School. Some of Dr. Nelson’s tips go out weekly to more than 3,000 members of the Orthopaedic Research Society (ORS), and all are distributed to more than 30 orthopaedic residency programs. Those not sent to the ORS are periodically reposted in OrthoBuzz with the permission of Dr. Nelson.
Approximately 20% of patients who undergo spine surgery have osteoporosis, which has a significant impact on spine-surgery complications such as failure of fixation devices and collapse fractures following fusion procedures. In a recent critical analysis review, authors focus on improving outcomes by identifying and optimizing patients with osteoporosis prior to spine surgery. The multidisciplinary team involved in that process should include primary care providers, endocrinologists, physical therapists, and orthopaedic surgeons.
The predominant tool for assessing bone mineral density (BMD) is dual x-ray absorptiometry. The diagnosis is based on a T score, which represents the number of standard deviations between the patient’s BMD and that of a healthy 30-year-old woman. Standard deviations ≤─2.5 define osteoporosis. The Z score is similar to the T score but compares the patient to an age- and sex-matched individual.
A history of low-energy fracture, such as a wrist fracture following a fall from a standing height, is considered a sentinel event for suspicion of fragility fractures. The combination of a fragility fracture and low BMD is considered to be severe osteoporosis. The most common form of osteoporosis is associated with a postmenopausal decrease in mineralization, but there are other causes. These include advanced kidney disease, hypogonadism, Cushing disease, vitamin D deficiency, anorexia and/or bulimia, rheumatoid arthritis, hyperthyroidism, primary hyperparathyroidism, and some medications (e.g., anticonvulsants, corticosteroids, heparin, and proton pump inhibitors).
Forty-seven percent of patients undergoing spine deformity surgery and 64% of cervical spine surgery patients have low vitamin D levels. Postoperative bone health can be enhanced in women ≥51 years old with daily intake of 800 to 1,000 units of vitamin D and 1,200 mg of daily calcium. There is no solid evidence that pre- or postoperative bisphosphonates have a positive impact on bone healing. Conversely, some series have shown that teriparatide, an anabolic parathyroid hormone, may improve time-to-fusion and help reduce screw pull-out after lumbar fusion in postmenopausal women.
Calcitonin has been shown to reduce the incidence of vertebral compression fracture, but there is no concrete evidence that it supports spine-fusion healing. Similarly, there is no strong evidence for the use of estrogen or selective estrogen receptor modulators in this surgical scenario. There is evidence that when the human monoclonal antibody denosumab is combined with teriparatide, spine-fusion healing may be improved relative to the use of teriparatide alone. Finally, the review article identifies screw size, screw position, and other surgical considerations that can improve fixation strength.
Using the “Own the Bone” practices promulgated by the American Orthopaedic Association and the technical considerations described in this review, we should be able to mitigate osteoporosis-related postoperative complications in spine-surgery patients.
What’s New in Musculoskeletal Infection 2020
Every month, JBJS publishes a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Click here for a collection of all OrthoBuzz specialty-update summaries.
This month, Thomas K. Fehring, MD, co-author of the July 15, 2020 “What’s New in Musculoskeletal Infection,” selected the five most clinically compelling findings—all focused on periprosthetic joint infection (PJI)—from among the more than 80 noteworthy studies summarized in the article.
PJI Prevention
–A retrospective case-control study1 found that patients who received an allogeneic blood transfusion during or after knee or hip replacement had a higher risk of PJI than those who were not transfused.
PJI Diagnosis
–A retrospective review2 found that using inflammatory markers to diagnose PJI in immunosuppressed joint-replacement patients is not suitable and that newly described thresholds for synovial cell count and differential have better operative characteristics.
Treating PJI
–A retrospective review3 of a 2-stage debridement protocol with component retention in 83 joint-replacement patients showed an 86.7% success rate of infection control at an average follow-up of 41 months.
–A single-center study4 of perioperative antibiotic selection for patients undergoing total joint arthroplasty found that the risk of PJI was 32% lower among those who received cefazolin compared with those who received other antimicrobial agents. The findings emphasize the importance of preoperative allergy testing in patients with stated beta-lactam allergies.
–A review of regional and state antibiograms5 showed that 75% of methicillin-sensitive S. aureus (MSSA) isolates and 60% of both methicillin-resistant S. aureus (MRSA) and coagulase-negative Staphylococcus isolates were susceptible to clindamycin, whereas 99% of all isolates were susceptible to vancomycin.
References
- Taneja A, El-Bakoury A, Khong H, Railton P, Sharma R, Johnston KD, Puloski S, Smith C, Powell J. Association between allogeneic blood transfusion and wound infection after total hip or knee arthroplasty: a retrospective case-control study. J Bone Jt Infect. 2019 Apr 20;4(2):99-105.
- Lazarides AL, Vovos TJ, Reddy GB, Kildow BJ, Wellman SS, Jiranek WA, Seyler TM. Traditional laboratory markers hold low diagnostic utility for immunosuppressed patients with periprosthetic joint infections. J Arthroplasty.2019 Jul;34(7):1441-5. Epub 2019 Mar 12.
- Chung AS, Niesen MC, Graber TJ, Schwartz AJ, Beauchamp CP, Clarke HD, Spangehl MJ. Two-stage debridement with prosthesis retention for acute periprosthetic joint infections. J Arthroplasty.2019 Jun;34(6):1207-13. Epub 2019 Feb 16.
- Wyles CC, Hevesi M, Osmon DR, Park MA, Habermann EB, Lewallen DG, Berry DJ, Sierra RJ. 2019 John Charnley Award: Increased risk of prosthetic joint infection following primary total knee and hip arthroplasty with the use of alternative antibiotics to cefazolin: the value of allergy testing for antibiotic prophylaxis. Bone Joint J.2019 Jun;101-B(6_Supple_B):9-15.
- Nodzo SR, Boyle KK, Frisch NB. Nationwide organism susceptibility patterns to common preoperative prophylactic antibiotics: what are we covering? J Arthroplasty.2019 Jul;34(7S):S302-6. Epub 2019 Jan 17.
JOPA 2019 Writing Awards
Since 2016, The Journal of Bone & Joint Surgery and JBJS Journal of Orthopaedics for Physician Assistants (JOPA) have awarded two $500 prizes to outstanding JOPA review articles or case studies written by authors who were PA students at the time of article submission.
The 2019 award winners for best articles by PA students produced high-quality literature reviews that address current and impactful topics. We recognized author Matthew Morrow, BA, PA-S out of Northwestern University for “The Effects of Cannabinoid Use on Acute Orthopaedic Pain: A Review of the Current Literature,” which showed that cannabis use provided little to no pain relief for acute musculoskeletal pain. The review also concluded that cannabis use while recovering from musculoskeletal trauma may be associated with an increased use of narcotics. The article suggests that cannabis use has a larger role for chronic rather than acute musculoskeletal pain.
Brittany Szabo, PA-S and Justin Gambini, MSPAS, PA-C, from Campbell University College of Pharmacy and Health Sciences, were recognized for “Ewing Sarcoma: A Review on Primary Bone Malignancy in Pediatrics and the Diagnosis, Treatment, and Challenges of Managing Ewing Sarcoma.” This article provided a comprehensive review of a “can’t miss” orthopaedic diagnosis, including clinical and diagnostic signs for orthopaedic providers to look for.
Congratulations to our 2019 PA student writing-award winners! We are offering two $500 awards again this year, so please encourage all of your PA students to submit an article for consideration! Deadline for submission is December 31, 2020.
And be on the lookout for an announcement about 2 additional 2019 JOPA Writing Award winners.
Dagan Cloutier, PA-C
Editor, JBJS Journal of Orthopaedics for Physician Assistants
Guidelines for Resuming Elective Orthopaedic Surgery
OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from Adam Bitterman, DO in response to 2 recent articles in the July 15, 2020 issue of The Journal of Bone & Joint Surgery.
The United States continues to struggle in the grip of the global COVID-19 pandemic. Certain regions within the US are experiencing a sharply increased COVID-19 case volume, while other locales have stabilized their disease burden. But overall, the country’s healthcare system and economy remain under stress.
Healthcare systems in regions that don’t have high COVID-19 burdens have begun to provide their full list of services, of which elective orthopaedic surgery is one. However, amid concern about a “second wave” of the pandemic, the reemergence of elective orthopedic surgery must be made–and monitored–in the context of public health. Now more than ever, surgeons and their patients must consider how individual patient-centered decisions might play out in the public domain.
As Anoushiravani and colleagues point out, the return of elective orthopedic surgery should be based in large part on the COVID-19 burden in any given geographic location. Local jurisdictions must regulate the return to “normalcy” according to measurements that gauge activity of the virus, such as the number of new diagnoses and hospitalizations and the percent occupancy of ICU beds. In another JBJS article on this topic, Parvizi et al. emphasize that local hospitals and health systems need to weigh resumption of elective orthopaedic procedures also against staffing capability and available supplies of PPE and ventilators. The sensible recommendations from both sets of authors emphasize the importance of ascertaining local disease patterns in order to provide appropriate and safe care for all patients.
The new “normal” in healthcare is a moving target that requires fluidity and flexibility to make frequent reassessments. The economic disruption caused by the pandemic may take years to resolve, and economics is another factor in these resuming-surgery equations. As members of the healthcare team, it is imperative that we focus on the well-being of our patients, surgical team and staff, and our local community. We all must be vigilant for signs of resurgence of the disease. And, please, wear a mask whenever you are out in public and social distancing is not feasible.
Adam Bitterman, DO is a foot and ankle specialist, an assistant professor of orthopaedic surgery at Zucker School of Medicine at Hofstra/Northwell, and a member of the JBJS Social Media Advisory Board.
Complex Reconstructions Call for Creative Solutions
Metastatic disease around the acetabulum often leads to patients needing total hip arthroplasty (THA), plus supplementary acetabular reconstruction. Traditional methods such as the Harrington reconstruction technique have shown good short-term outcomes, but there are concerns that a cemented acetabular component in this setting is at risk for failure in the longer term. Newer approaches, such as using cementless tantalum acetabular components with augments, have also shown promise. Houdek et al. compared these 2 approaches and report the findings in the July 15, 2020 issue of The Journal.
The authors followed 115 patients who underwent THA for metastatic disease at 2 tertiary sarcoma centers, with a mean 4-year follow-up among surviving patients. They compared the outcomes of 78 Harrington reconstructions with those of 37 tantalum reconstructions, with surgeons at each center exclusively performing 1 of the 2 techniques. The cohorts were comparable at baseline regarding age, sex, severity of systemic disease and acetabular defects, and pelvic discontinuity. Functional outcomes improved in both groups, but there were no significant between-group differences. The main statistical finding of the study was that a higher percentage of patients in the Harrington reconstruction group (27%) needed a reoperation than those in the tantalum group (8%), with a hazard ratio of 4.59 (p=0.003).
Historically, there has been an understandable lack of long-term follow-up in this fragile patient population; 94 of the 115 patients in this study died of systemic disease progression at an average of 16 months after surgery. Overall patient survival was only 34% at 2 years and 15% at 10 years. Despite these grim mortality numbers, Houdek et al. claim that with advances in treatments for metastatic cancer, patients are living longer and therefore may benefit from more durable acetabular reconstructions.
This study leaves unanswered the question of whether the theoretic advantage of bony ingrowth with tantalum is what accounted for the decreased reoperation rates. As Albert Aboulafia, MD notes in his Commentary on this study, the authors did not review radiographs or postmortem histology to look for evidence of osseointegration. But Houdek et al. do present a potential avenue for further investigation. And what remains clear is that metastatic disease around the hip is a complex problem, and that we as surgeons should continue to investigate promising treatment strategies to improve patient outcomes (even if only palliative) and enhance biological fixation.
Click here for a 4-minute video in which co-author Matthew Houdek explains the rationale for this study.
Matthew R. Schmitz, MD
JBJS Deputy Editor for Social Media
The NSAID-Fracture Nonunion Debate Continues
Many animal studies have investigated the impact of nonselective NSAIDs and selective COX-2 inhibitors on fracture healing. Nearly all those experiments focused on chronic drug administration following simulated long-bone fractures. One concern regarding the clinical relevance of those animal studies is that the “fractures” are often created by open means, which results in cortical devascularization and which may not accurately simulate the most common long-bone fracture pathophysiology in humans. Nevertheless, many orthopaedic surgeons have used the results of those animal studies to limit—or even stop—their use of NSAIDs to treat postfracture pain.
In the July 15, 2020 issue of The Journal, George et al. use a large private-insurance database to investigate the association between postfracture prescriptions filled for NSAIDS (both selective COX-2 inhibitors and nonselective types) and the subsequent diagnosis of a nonunion at 1 year postinjury. Administrative database research is more useful for generating hypotheses than for proving or disproving them, and these authors (along with Commentary writer Willem-Jan Metsemakers, MD, PhD) rightly point out that adequately powered randomized trials are needed to more fully address this issue.
Still, I was a bit surprised by the finding that nonselective NSAIDs were not associated with the diagnosis of nonunion while selective COX-2 inhibitors were. It seems to me that, given the sparse and conflicting clinical evidence today, a brief course of NSAIDs for fracture-related pain management should be included for patients while we await answers from studies with more robust research designs.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
Questions About Survival of Ultraporous Cups in THA
Acetabular components for primary total hip arthroplasty (THA) made with ultraporous surfaces were developed to enhance osseointegration and biological fixation. In the July 1, 2020 issue of The Journal of Bone & Joint Surgery, Palomaki et al. report on a registry study that suggests that implant survival with these components over an average follow-up of 3.6 years is not so “ultra.”
The authors evaluated >6,000 primary THAs that used a Tritanium ultraporous cup and >25,000 THAs that used a conventional cup, all performed between 2009 and 2017. When they compared the two groups for revision for any reason, the 5-year Kaplan-Meier survivorship of the Tritanium group (94.7%) was inferior to that of the conventional-cup group (96.0%). When revision for aseptic loosening was examined, the 5-year survivorship was also inferior for the Tritanium group (99.0%) compared with the conventional group (99.9%). Regression analysis revealed that the Tritanium group had a much higher risk of revision for aseptic loosening 2 to 4 years after surgery (hazard ratio, 11.2; p <0.001). Interestingly, these survivorship and risk-of-revision differences disappeared when the authors analyzed data for the period from May 15, 2014 to December 31, 2017–when the registry was updated to include patient BMI and ASA-class data.
The authors cite several caveats that readers should apply to these findings. The registry did not capture radiographic findings for these patients, so potentially relevant imaging data could not be analyzed. And, despite the database upgrade in 2014, there was a dearth of available data on patient comorbidities. Finally, wide confidence intervals for some of the hazard-ratio calculations suggest the need to confirm revision-risk findings with further research.
Limitations notwithstanding, the study by Palomaki et al. suggests that the performance of ultraporous cups may not meet the hopes and expectations of hip surgeons and their patients.
What’s New in Orthopaedic Trauma 2020
Every month, JBJS publishes a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Click here for a collection of OrthoBuzz summaries of these “What’s New” articles. This month, co-author Niloofar Dehghan, MD, selected the 5 most clinically compelling findings from the >20 studies summarized in the July 1, 2020 “What’s New in Orthopaedic Trauma.”
Hip Fracture
—An international randomized controlled trial (RCT) of hip fracture patients ≥45 years of age1 compared outcomes among 1,487 who underwent an “accelerated” surgical procedure (within 6 hours of diagnosis) and 1,483 who received “standard care” (surgery within 24 hours of diagnosis). Mortality and major complication percentages were similar in both groups, but it is important to note that even the standard-care group had a relatively rapid median time-to-surgery of 24 hours.
—An RCT of nearly 1,500 patients who were ≥50 years of age and followed for 2 years2 compared total hip arthroplasty (THA) with hemiarthroplasty for the treatment of displaced femoral neck fractures. There was no between-group difference in the need for secondary surgical procedures, but hip instability or dislocation occurred in 4.7% of the THA group versus 2.4% of the hemiarthroplasty group. Functional outcomes measured with the WOMAC index were slightly better (statistically, but not clinically) in the THA group. Serious adverse events were high in both groups (41.8% in the THA group and 36.7% in the hemiarthroplasty group). Although the authors conclude that the advantages of THA may not be as compelling as has been purported, THA’s benefits may become more pronounced with follow-up >2 years.
—A preplanned secondary analysis of data from the FAITH RCT examined the effect of posterior tilt on the need for subsequent arthroplasty among older patients with a Garden I or II femoral neck fracture who were treated with either a sliding hip screw or cannulated screws. Patients with a posterior tilt of ≥20° had a significantly higher risk of subsequent arthroplasty (22.4%) compared with those with a posterior tilt of <20° (11.9%). In light of these findings, instead of internal fixation, primary arthroplasty may be an appropriate treatment for older patients who have Garden I and II femoral neck fractures with posterior tilt of >20°.
Ankle Syndesmotic Injury
—An RCT that compared ankle syndesmosis fixation using a suture button with fixation using two 3.5-mm screws3 found a higher rate of malreduction at 3 months postoperatively with screw fixation (39%) than with suture button repair (15%). With the rate of reoperation also higher in the screw group due to implant removal, these findings add to the preponderance of recent evidence that the suture button technique is preferred.
Wound Management
—A 460-patient RCT examining the cost-effectiveness of negative-pressure wound therapy4 for initial wound management in severe open fractures of the lower extremity found the technique to be associated with higher costs and only marginal improvement in quality-adjusted life-years for patients.
References
- HIP ATTACK Investigators. Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial. Lancet.2020 Feb 29;395(10225):698-708. Epub 2020 Feb 9.
- Bhandari M, Einhorn TA, Guyatt G, Schemitsch EH, Zura RD, Sprague S, Frihagen F, Guerra-Farfán E, Kleinlugtenbelt YV, Poolman RW, Rangan A, Bzovsky S, Heels-Ansdell D, Thabane L, Walter SD, Devereaux PJ; HEALTH Investigators. Total hip arthroplasty or hemiarthroplasty for hip fracture. N Engl J Med.2019 Dec 5;381(23):2199-208. Epub 2019 Sep 26.
- Sanders D, Schneider P, Taylor M, Tieszer C, Lawendy AR; Canadian Orthopaedic Trauma Society. Improved reduction of the tibiofibular syndesmosis with TightRope compared with screw fixation: results of a randomized controlled study. J Orthop Trauma.2019 Nov;33(11):531-7.
- Petrou S, Parker B, Masters J, Achten J, Bruce J, Lamb SE, Parsons N, Costa ML; WOLLF Trial Collaborators. Cost-effectiveness of negative-pressure wound therapy in adults with severe open fractures of the lower limb: evidence from the WOLLF randomized controlled trial. Bone Joint J.2019 Nov;101-B(11):1392-401.
Patients as Teachers: Surgeons as Students
In the July 1, 2020 issue of The Journal, Dr. C. McCollister Evarts, writes an illuminating “What’s Important” essay about learning from his most difficult cases. He recounts an event early in his career as a medical officer aboard an aircraft carrier, when a fat embolism caused the untimely death of a young adult patient he treated for a closed tibial fracture. This event spurred a lifelong quest for knowledge about surgery-associated emboli, about which cases and literature were sparse at the time (mid-1960s). My quick search of Dr. Evarts’ long list of publications shows that more than 20 of them are related to embolic events, no doubt a direct result of the experience with that seaman many years ago, and with another one of his early-career patients who died of a pulmonary embolism a week after undergoing hip surgery.
We should all look toward our patients to teach us ways to improve our craft. Not every procedure goes as planned, and the day a surgeon stops trying to get better should likely be the day he or she starts contemplating retirement. Dr. Evarts states that “each and every encountered complication should be carefully examined with the goal of ultimately providing better care.”
Instead of fearing complications, orthopaedic surgeons should carefully analyze the root causes of complications as part of their career-long effort to learn and improve. Our patients can be our teachers in these difficult situations, and we should be willing and open students. This teacher-student approach might require a difficult conversation with the patient or their family to understand why the procedure didn’t go as planned or the outcomes weren’t what was envisioned. As Dr. Evarts points out in his essay, “Most family members do not understand what has happened when a complication occurs, and they appreciate an explanation in a face-to-face meeting.”
The adage that “you learn something new every day” is more likely to come true if you pay extra attention to your most difficult cases. As practicing surgeons, we are never “finished.” We should strive to remain teachable students, always learning from our patient-teachers.
Matthew R. Schmitz, MD
JBJS Deputy Editor for Social Media
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