3 Reference Axes Help Ensure Rotational Alignment During TKA
Rotational malalignment of the femoral component during total knee arthroplasty (TKA) is associated with poor outcomes, but how best to assess femoral component rotation intraoperatively remains an unanswered question for arthroplasty surgeons. Now, in the largest study of its kind, Jang et al. conclude in the December 4, 2019 issue of JBJS that combining 3 reference axes is the optimal strategy for ensuring accurate femoral component positioning, sex/ethnic generalizability, and intraoperative efficiency.
The authors compared 5 reference axes commonly used for intraoperative assessment of femoral component rotation by mapping them to >2,100 entire-femur CT scans from patients with nonarthritic knees. Using the surgical transepicondylar axis (sTEA) as the gold-standard reference, Jang et al. found that no single other axis was both highly accurate and relatively immune to ethnic and sex variability. Based on their findings, they instead recommend using a combination of 3 axes—posterior condylar axis externally rotated 3° (PCA + 3° ER), the Whiteside or sulcus line, and the anatomical transepicondylar axis (aTEA)—to ensure rotational alignment.
The authors also suggest a straightforward intraoperative process for using these 3 axes:
- Start with the PCA + 3° ER, which most accurately approximates the gold-standard sTEA.
- Then use the Whiteside or sulcus line, neither of which is significantly affected by sex or ethnicity.
- Finally, palpate for the aTEA to narrow the margin of error.
Citing a limitation to this CT-based study of nonarthritic knees, the authors note that “we could not account for the effects of cartilage wear or other changes caused by degenerative arthritis.”
RCT: Single IV Dose of TXA Is Safe, Effective for TKA
Along the spectrum of early and late adopters in medicine, most orthopaedic surgeons fall in the middle. They wait for science to prove the efficacy and safety of an innovation, carefully review the published studies regarding that innovation, and adopt it if it will improve their patients’ outcomes.
In the December 4, 2019 issue of JBJS, Jules-Elysee et al. compare tranexamic acid (TXA) administered intravenously (IV) versus topically in a double-blinded, randomized controlled trial (RCT) of patients undergoing primary total knee arthroplasty (TKA). Level-I evidence is rare in the orthopaedic literature, so when a well-performed RCT comes out, we should closely evaluate its findings.
A potent antifibrinolytic, TXA has been shown in multiple studies to decrease blood loss associated with major orthopaedic procedures. However, there are persistent (but not necessarily evidence-based) concerns about its potential to cause thrombogenic complications, and the safest and most effective route of TXA administration remains an open question.
In this study, the IV group received TXA once before tourniquet inflation and again 3 hours later, along with a topical placebo given 5 minutes before tourniquet release. The topical group received an IV placebo at the same time intervals as the IV group, along with TXA delivered topically in the wound prior to tourniquet release. The authors found lower systemic levels of plasmin-anti-plasmin (PAP, a measure of fibrinolysis) in both groups 1 hour after tourniquet release, but PAP levels remained significantly lower in the IV group (indicating higher antifibrinolytic activity) 4 hours after tourniquet release, which was likely related to the second IV dose of TXA.
The authors also found no between-group difference in systemic or wound levels of prothrombin fragment 1.2 (PF1.2, a marker of thrombin generation), indicating there was no increase in thrombogenicity in the IV group. Interestingly, Jules-Elysee also found that the IV group had significantly higher hemoglobin and hematocrit levels 1 and 2 days after surgery, and those patients had a significantly shorter hospital stay.
Finding no major between-group differences in the mechanism of action, coagulation, or fibrinolytic profile, the authors concluded that a single IV dose of TXA may be the most simple protocol for hospitals to adopt if they are still concerned about TXA safety. Perhaps these Level-I findings will help some of the late adopters get over their fears about the safety of IV TXA.
Matthew R. Schmitz, MD
JBJS Deputy Editor for Social Media
Meta-Analysis Quality Improving, But Issues Remain
Hip and knee arthroplasty are common procedures worldwide and are increasing annually as demographics change and the technical aspects of these surgeries become more accessible to a broader swath of surgeons. The sheer number of these procedures makes them an appropriate focus for randomized controlled trials (RCTs). The aggregation of RCT data into more powerful statistical frameworks is the job of a meta-analysis.
Not surprisingly, we have seen an increasing number of meta-analyses related to hip and knee replacement published across all major orthopaedic journals during the last two decades. Authors have two common motivations for conducting meta-analyses. The first, to summarize data from carefully conducted RCTs into clinically relevant and important recommendations, is hopefully the most common motivation—and certainly the most justifiable. The second, to merely use previously published data as an analytic exercise to advance one’s academic career without investing the time and effort to do prospective research, is not justifiable, in my estimation.
In the December 4, 2019 issue of The Journal, Park et al. conduct quality and usefulness assessments of 114 published meta-analyses about hip and knee arthroplasty that appeared in 3 major orthopaedic journals (one of which was JBJS) from 2000 to 2017. They document a nearly 4-fold increase in the number of meta-analyses published on these topics when comparing 2000 to 2009 with 2010 to 2017. Based on Oxman-Guyatt Index scores of overall study quality, only 12 of the 114 studies were assessed as high quality, 87 as moderate quality, and 15 as low quality.
Here are some additional findings:
- The majority of these meta-analyses were not performed in accordance with established PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.
- Only 39% of these articles showed the risk of bias.
- Many of these meta-analyses covered redundant topics within the same year or within a few years of each other.
- A review by expert attending surgeons of the 24 studies determined to be high quality per PRISMA found that 71% were either clinically unimportant or inconclusive.
It is a positive step to highlight for our readers the important quality issues surrounding meta-analyses, and I agree with James Stoney, who commented on these findings: “The onus is on surgeons to carefully scrutinize meta-analyses…and come to individual conclusions about the quality of the research rather than accept the conclusions at face value.”
But I am discouraged to see the number of problematic meta-analyses that have appeared in our literature, and I suspect most of these quality problems arise from the second, unjustifiable motivation noted above. We need to do better as a research community, as peer reviewers, and as journal editors to improve the quality of published meta-analyses so that we can favorably impact patient care and advance the clinical practice of hip and knee arthroplasty.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
What’s New in Orthopaedic Rehabilitation 2019
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 such OrthoBuzz summaries.
This month, co-author Nitin B. Jain, MD, MSPH selected the most clinically compelling findings from the 40 studies summarized in the November 20, 2019 “What’s New in Orthopaedic Rehabilitation.”
Pain Management
–A randomized controlled trial compared pain-related function, pain intensity, and adverse effects among 240 patients with chronic back, hip, or knee pain who were randomized to receive opioids or non-opioid medication.1 After 12 months, there were no between-group differences in pain-related function. Statistically, the pain intensity score was significantly lower in the non-opioid group, although the difference is probably not clinically meaningful. Adverse events were significantly more frequent in the opioid group.
–A series of nested case-control studies found that the use of the NSAID diclofenac was associated with an increase in the risk of myocardial infarction in patients with spondyloarthritis and osteoarthritis, relative to those taking the NSAID naproxen.2
–Intra-articular injections of corticosteroids or hyaluronic acid are often used for pain relief prior to an eventual total knee arthroplasty (TKA). An analysis of insurance data found that patients who had either type of injection within three months of a TKA had a higher risk of periprosthetic joint infection (PJI) after the operation than those who had injections >3 months prior to TKA.
Partial-Thickness Rotator Cuff Tears
–A randomized controlled trial of 78 patients with a partial-thickness rotator cuff compared outcomes of those who underwent immediate arthroscopic repair with outcomes among those who delayed operative repair until completing 6 months of nonoperative treatment, which included activity modification, PT, corticosteroid injections, and NSAIDs.3 At 2 and 12 months post-repair, both groups demonstrated improved function relative to initial evaluations. At the final follow-up, there were no significant between-group differences in range of motion, VAS, Constant score, or ASES score. Ten (29.4%) of the patients in the delayed group dropped out of the study due to symptom improvement.
Stem Cell Therapy
–A systematic review that assessed 46 studies investigating stem cell therapy for articular cartilage repair4 found low mean methodology scores, indicating overall poor-quality research. Only 1 of the 46 studies was classified as excellent, prompting the authors to conclude that evidence to support the use of stem cell therapy for cartilage repair is limited by a lack of high-quality studies and heterogeneity in the cell lines studied.
References
- Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA. 2018 Mar 6;319(9):872-82.
- Dubreuil M, Louie-Gao Q, Peloquin CE, Choi HK, Zhang Y, Neogi T. Risk ofcmyocardial infarction with use of selected non-steroidal anti-inflammatory drugs incpatients with spondyloarthritis and osteoarthritis. Ann Rheum Dis. 2018 Aug;77(8): 1137-42. Epub 2018 Apr 19.
- Kim YS, Lee HJ, Kim JH, Noh DY. When should we repair partial-thickness rotator cuff tears? Outcome comparison between immediate surgical repair versus delayed repair after 6-month period of nonsurgical treatment. Am J Sports Med. 2018 Apr;46(5):1091-6. Epub 2018 Mar 5.
- Park YB, Ha CW, Rhim JH, Lee HJ. Stem cell therapy for articular cartilage repair: review of the entity of cell populations used and the result of the clinical application of each entity. Am J Sports Med. 2018 Aug;46(10):2540-52. Epub 2017 Oct 12.
Surgeon Volume Matters for TKA Alignment
The retrospective multicenter study of 1,570 primary total knee arthroplasties (TKAs) by Kazarian et al. in the October 2, 2019 issue of JBJS focused on evaluating the impact of surgeon volume and training status on implant alignment. But the most surprising (and concerning) finding was that even among high-volume attendings—the best-performing of the three surgeon cohorts studied—the proportion of TKA alignment “outliers” was still high.
The authors radiographically measured 3 postoperative TKA alignment parameters: medial distal femoral angle (DFA), medial proximal tibial angle (PTA), and posterior tibial slope angle (PSA). Using established thresholds for “outliers” and “far outliers” for those 3 measurements, the authors compared the radiographic findings among surgeries performed by high-volume attendings (≥50 TKAs/year), low-volume attendings (<50 TKAs/year), and trainees (supervised residents or fellows).
As has been shown in similar studies of total hip arthroplasty (THA), the group of high-volume attendings outperformed the low-volume attendings and the trainee group on nearly all measurements assessed in this study. Interestingly, in terms of TKA alignment, the low-volume attending group and the trainee group performed similarly.
Kazarian et al. express concern that “even the most accurate cohort in our study, [the high-volume attendings], placed only 69.0% of knees in optimal alignment for all 3 measurements.” While the authors admit that implant alignment is not a perfect proxy for clinical outcomes, they argue that “gross alignment outliers are likely to have an impact on knee function, kinematics, and wear characteristics.” Citing literature suggesting that the use of robotic-arm assistance may improve TKA alignment, the authors surmise that employing such technology to assist low-volume surgeons or trainees might optimize alignment and improve outcomes, despite the added up-front cost of the technology.
Patient Discharge after Knee Replacement: How Soon Is Safe?
For most patients and payers, getting out of the hospital quickly after a knee replacement is very important. For orthopaedic surgeons, excellent patient outcomes are the top priority. The latest one-hour complimentary webinar from JBJS on Tuesday, October 1, 2019 at 8:00 pm EDT will reveal clinical practices that increase the odds of achieving both of those goals.
Co-authors Nelson SooHoo, MD and Armin Arshi, MD will explore data from their JBJS study comparing complication rates after outpatient and inpatient knee-replacement, emphasizing that outpatients must receive the same attention to infection prevention, thromboprophylaxis, and rehabilitation as inpatients.
Kurt Spindler, MD and Robert Molloy, MD will then delve into their JBJS study, which suggests that hospital site, surgeon, and day of the week are more accurate predictors of length of hospital stay after knee replacement than patient age, BMI, and comorbidities.
Moderated by Daniel Berry, MD of the Mayo Clinic, the webinar will also feature expert commentaries by Joseph Moskal, MD and Ronald Delanois, MD. The webinar will conclude with a 15-minute live Q&A session during which attendees can ask questions of all the panelists.
Seats are limited, so Register Now!
Morbidly Obese Patients Should Lose ≥20 Pounds Prior to TKA
The obesity epidemic continues throughout much of the developed world. Among the morbidly obese (BMI ≥40 kg/m2), we have a group of patients in whom arthritis is very likely to develop due to excessive loading of articular cartilage, chronic inflammation, and alignment problems. At the same time, many arthroplasty surgeons are wary of treating morbidly obese patients with surgery because of the increased perioperative risks. Although many of these patients still benefit greatly from joint replacement, in today’s “value-based care” environment, some institutions have implemented BMI cutoff thresholds for performing knee or hip arthroplasty. Others have set weight-loss requirements before they will schedule lower-extremity arthroplasty for morbidly obese patients. One still-unanswered question along these lines is: how much weight does a morbidly obese patient need to lose preoperatively in order to improve the outcome after a knee replacement?
Keeney et al. address that question in the August 21, 2019 issue of The Journal. In a retrospective cohort study, the authors evaluated outcomes among 203 morbidly obese patients who underwent a total knee arthroplasty (TKA). They found that a loss of 20 pounds preoperatively was associated with a shorter length of stay and a lower chance of being discharged to a rehab or skilled nursing facility rather than home. However, a 20-pound weight loss had no impact on surgical time or functional outcomes, as measured with the PROMIS-10 physical component score. Of note, only 14% of the evaluated patients lost at least 20 pounds preoperatively (highlighting the difficulty of losing weight in general and among this patient population in particular). There were no benefits of any kind in patients who lost only 5 or 10 pounds preoperatively.
While this study’s sample size is small, the findings provide evidence surgeons can use to encourage (or insist upon) larger amounts of weight loss before arthroplasty procedures in morbidly obese patients. In this study, the patients who lost at least 20 pounds remained morbidly or severely obese, and all the patients eventually regained most or all of the weight they lost. Still, the conclusion that at least 20 pounds of weight loss is beneficial for morbidly obese patients prior to a TKA remains sound. Because of the magnitude of this public health issue, we need more high-quality outcomes research (preferably using more knee-specific functional measures) on preoperative management of morbidly obese patients who are considering lower-extremity arthroplasty.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
Good Outcomes and Savings with Preferred-Vendor Program
It has been said that outcomes of total joint arthroplasty are 90% related to surgeon factors (such as prosthetic alignment and fit and soft-tissue management), and only 10% to the implant itself. Historically, surgeon choices of implants for primary total hip and total knee arthroplasty have been based on influences such as the prostheses used during training, prior vendor relationships, specific patient characteristics, and findings in published literature. Absent evidence that the selection of prosthesis vendor affects patient outcomes to any significant degree, and with the universal focus on lowering health care costs, surgeon implant/vendor preferences have come under close scrutiny.
In the August 7, 2019 issue of The Journal, Boylan et al. study the impact of a voluntary preferred single-vendor program at a large, high-volume, urban orthopaedic hospital with >40 (mostly hospital-employed) arthroplasty surgeons. The hospital’s use of hip and knee arthroplasty implants from the preferred vendor rose from 50% to 69% during the program’s first year. In addition, the mean cost per case of cases in which implants from the preferred vendor were used were 23% lower than the mean cost-per-case numbers from the previous year (p<0.001). Boylan et al. noted that low-volume surgeons adopted the initiative at a higher rate than high-volume surgeons, and that surgeons were more compliant with using the preferred vendor for total knee implants than for total hip implants.
Why is it that some higher-volume surgeons seem resistant to change? It is not clear from the data presented in this study whether the answer is familiarity with an instrument system, loyalty to local representatives, or relationships with manufacturers based on financial or personal connections. The authors observed that “collaboration between surgeons and administrators” was a critical success factor in their program, and interestingly, the 3 highest-volume surgeons in this study (who performed an average of ≥20 qualifying cases per month) all used total knee implants from the preferred vendor prior to the initiation of this program.
The provocative findings from this and similar studies lead to many questions ripe for further research. Because hospitals are highly motivated to reduce implant costs in the bundled-payment environment, preferred-vendor programs are gathering steam. We need to better understand how they work (or don’t) for specific surgeons, within surgical departments, and within hospital/insurance systems in order to evaluate their effects on patient outcomes and maximize any cost benefits.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
Delaying Knee Replacement: Driven to Distraction?
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.
Some symptomatic patients with knee osteoarthritis (OA) present relatively early in the radiographic disease process, while others present after serious articular cartilage loss has occurred. In either case, young knee OA patients are often looking for ways to get relief while postponing a total knee arthroplasty (TKA).
One such recently introduced alternative is knee joint distraction (KJD), a joint-preserving surgery used for bicompartmental tibiofemoral knee osteoarthritis or unilateral OA with limited malalignment. Significant long-term clinical benefit as well as durable cartilage tissue repair have been reported in an open prospective study with 5 years of follow-up.1 A more recent study of distraction2 presents 2-year follow-up results of a 2-pronged trial that measured patient-reported outcomes, joint-space width (JSW), and systemic changes in biomarkers for collagen type-II synthesis and breakdown.
In one arm, end-stage knee OA patients who were candidates for TKA were randomized to KJD (n=20) or TKA (n=40). In the second arm, earlier-stage patients with medial compartment OA and a varus angle <10° were randomized to KJD (n=23) or high tibial osteotomy (HTO; n=46). In the distraction patients, the knee was distracted 5 mm for 6 weeks using external fixators with built-in springs, placed laterally and medially, and weight-bearing was encouraged. WOMAC scores and VAS pain scores were assessed at baseline and at 3, 6, 12, 18, and 24 months.
At 24 months, researchers found no significant differences between the KJD and HTO groups in that part of the trial. In the KJD/TKA arm, there was no difference in WOMAC scores between the two groups, but VAS scores were lower in the TKA group. The improvement in mean joint space width seen at one year in the KJD group of the KJD/TKA arm decreased by two years, though the values were still improved compared to baseline. However, the joint space width improvement seen at 1 year for both groups in the KJD/HTO arm persisted for two years. For all KJD patients, the ratio of biomarkers of synthesis over breakdown of collagen type-II was significantly decreased at 3 months but reversed to an increase between 9 and 24 months.
It is hard to believe that 6 weeks of joint distraction could trigger a process that yields such positive and long-lasting results. While much more research with longer follow-up is needed, KJD may prove particularly useful in younger knee OA patients trying to delay joint replacement.
References
- van der Woude, JAD, Wiegant, K, van Roermund, PM, Intema, F, Custers, RJH, Eckstein, F. Five-year follow-up of knee joint distraction: clinical benefit and cartilaginous tissue repair in an open uncontrolled prospective study. Cartilage. 2017;8:263-71.
- Jansen MP, Besselink NJ, van Heerwaarden RJ, Roel J.H. Custers1, Jan-Ton A.D. Van der Woude J-TAD, Wiegant K, Spruijt S, Emans PJ, van Roermund PM, Mastbergen SC, Lafeber FP. Knee joint distraction compared with high tibial osteotomy and total knee arthroplasty: two-year clinical, structural, and biomarker outcomes. ORS 2019 Annual Meeting Paper No. 0026 (Cartilage. 2019 Feb 13:1947603519828432. doi: 10.1177/1947603519828432. [Epub ahead of print])
Study Supports Routine Patellar Resurfacing during TKA
The July 17, 2019 issue of The Journal features another investigation evaluating patellar resurfacing. Despite much research (see related OrthoBuzz post), this topic remains controversial among many total knee arthroplasty (TKA) surgeons. This study, by Vertullo et al., analyzed data from the Australian Orthopaedic Association National Joint Replacement Registry. The findings suggest that routine resurfacing of the patella reduces the risk of revision surgery for TKA patients.
The authors evaluated more than 136,000 TKA procedures after placing the cases into three groups based on the surgeon’s patellar-resurfacing preference: infrequent (<10% of the time), selective (10% to 90% of the time), or routine (≥90% of the time). All of the cases evaluated utilized minimally stabilized components and cemented or hybrid fixation techniques, and they all were performed by surgeons who completed at least 50 TKAs per year.
The authors found that patients in the infrequent-resurfacing cohort had a nearly 500% increased risk of undergoing subsequent patellar revision during the first 1.5 years after TKA, compared to those in the routine-resurfacing cohort. Even more surprising to me was the finding that patients in the selective-resurfacing cohort had a >300% increased risk of needing a patellar revision within the first 1.5 years, compared to those in the routine-resurfacing cohort. In addition, the risk of all-cause revision was 20% higher in the selective cohort compared to the routine cohort.
What struck me most about this study were the differences between the selective and routine cohorts. One of the arguments against routine resurfacing of the patella is that surgeons should decide intra-operatively, on a patient-by-patient basis, whether the osteochondral health and biomechanics of the native patella warrant resurfacing. The findings of Vertullo et al. seem to call that reasoning into question. Although the results of this study add to the evidence supporting the routine resurfacing of the patella during TKA, I would like to reiterate a proviso from my earlier post on this topic: resurfacing is associated with added costs and an increased risk of potential complications.
Chad A. Krueger, MD
JBJS Deputy Editor for Social Media
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