RESUMEN
Arthroscopic acromioplasty is one of the most commonly performed orthopedic surgical procedures. The indication for performing an acromioplasty has traditionally been based on the mechanical theory of impingement of the coracoacromial arch on the soft tissues of the rotator cuff footprint. Orthopedic surgeons have recommended surgically decompressing this phenomenon for six decades to eliminate shoulder pain and restore function. Recent high-level studies have cast doubt on the value of acromioplasty compared to other nonoperative treatment modalities. There is also an increased recognition and awareness that rotator cuff disease is as much a degenerative and senescent process as it is a mechanical one. There is now good evidence that the incidence of acromioplasty is falling significantly, especially in treatment scenarios that involve an intact rotator cuff. The cause of this decrease must be understood as multifactorial and related to both the clinical evidence and the economics and reimbursement policy concerning acromioplasty. Like many other high-volume and elective orthopedic surgical procedures, third-party reimbursement policy dictates patient access to treatments. Yet, current and future literature and clinical expertise determine proper indications for acromioplasty. Doctors are in the best position to indicate proper patient care.
Asunto(s)
Acromion , Lesiones del Manguito de los Rotadores , Acromion/cirugía , Artroplastia , Artroscopía , Humanos , Incidencia , Manguito de los Rotadores/cirugía , Lesiones del Manguito de los Rotadores/cirugíaRESUMEN
BACKGROUND: There has been 25-year trend of decreasing value for orthopedic surgical work based on the Resource-Based Relative Value Scale (RBRVS) for Medicare reimbursement. This study was undertaken to estimate the time that Medicare payment rates for time spent in the office doing cognitive work will equal time dedicated in the operating room to performing procedural work based on long-term negative payment trends. METHODS: The RBRVS Update Committee database was accessed to extract the time elements for 2 procedures, total knee arthroplasty and total hip arthroplasty (27447 and 27130), on the day of surgery. The evaluation and management code mix for 2 mid-sized orthopedic practice was averaged to create an amalgamated rate for the reimbursement of office work on an hourly rate. A graph of the 25-year trend line in Medicare reimbursement for arthroplasty procedures was used to create a trend line. The trend line was then extrapolated to estimate the time in the future that the hourly rate for office work would equal the hourly rate for surgery. RESULTS: Time inputs and the Medicare conversion factor for 2021 were used in this analysis. Total procedural time for both 27447 and 27130 was 204 minutes (3.4 hours) on the day of surgery. An amalgamated hourly office rate of 7.9 relative value unit was calculated from the average of the 2 mid-sized private practices for an overall in office Medicare reimbursement of $318.89/h, with $1083.04 for the 3.4 hours allowed in the RBRVS Update Committee database for a joint replacement. When the trend line for reimbursement was extrapolated to the $1083.04 price point, the year corresponding to the point where hourly office reimbursement would equal hourly surgical work was 2024. CONCLUSION: Policymakers in Washington and practicing orthopedic surgeons need to consider the looming economic parity of surgical and cognitive work for Medicare. Continued negative reimbursement rates are likely to decrease patient access to necessary surgical care and result in de facto rationing of arthroplasty services for Medicare patients. The deployment of the orthopedic workforce is likely to change to accommodate the decreases in the value of surgical work. This trend will have significant impact on the practice of musculoskeletal medicine and patient access to orthopedic services.
Asunto(s)
Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Procedimientos Ortopédicos , Anciano , Humanos , Medicare , Mecanismo de Reembolso , Escalas de Valor Relativo , Estados UnidosRESUMEN
The value of surgeon procedural work is currently determined through a fee-setting process controlled by the Centers for Medicare & Medicaid Services. This process relies on the Resource-Based Relative Value Scale (RBRVS) to advise the Centers for Medicare & Medicaid Services concerning surgical work reimbursement. This system and several other government policy decisions over the past 25 years have placed orthopaedic surgeons at great disadvantage in establishing and maintaining the value of orthopaedic surgical work. Continued reliance on the RBRVS will result in further reductions in surgical reimbursements and may affect patient access to orthopaedic services. Orthopaedic surgeons must consider moving away from the RBRVS and Current Procedural Terminology as a way of determining value and instead establish price as the value signal in orthopaedic medicine. Bundled-payment methodologies offer one mechanism for establishing price in the marketplace.
Asunto(s)
Escalas de Valor Relativo , Cirujanos , Anciano , Current Procedural Terminology , Humanos , Medicare , Pacientes Ambulatorios , Patient Protection and Affordable Care Act , Manguito de los Rotadores , Estados UnidosRESUMEN
PURPOSE: To create and determine face validity and content validity of arthroscopic rotator cuff repair (ARCR) performance metrics, to confirm construct validity of the metrics coupled with a cadaveric shoulder, and to establish a performance benchmark for the procedure on a cadaveric shoulder. METHODS: Five experienced arthroscopic shoulder surgeons created step, error, and sentinel error metrics for an ARCR. Fourteen shoulder arthroscopy faculty members from the Arthroscopy Association of North America formed the modified Delphi panel to assess face and content validity. Eight Arthroscopy Association of North America shoulder arthroscopy faculty members (experienced group) were compared with 9 postgraduate year 4 or 5 orthopaedic residents (novice group) in their ability to perform an ARCR. Instructions were given to perform a diagnostic arthroscopy and a 2-anchor, 4-simple suture repair of a 2-cm supraspinatus tear. The procedure was videotaped in its entirety and independently scored in blinded fashion by trained, paired reviewers. RESULTS: Delphi panel consensus for 42 steps and 66 potential errors was obtained. Overall performance assessment showed a mean inter-rater reliability of 0.93. Novice surgeons completed 17% fewer steps (32.1 vs 37.5, P = .001) and enacted 2.5 times more errors than the experienced group (6.21 vs 2.5, P = .012). Fifty percent of the experienced group members and none of the novice group members achieved the proficiency benchmark of a minimum of 37 steps completed with 3 or fewer errors. CONCLUSIONS: Face validity and content validity for the ARCR metrics, along with construct validity for the metrics and cadaveric shoulder, were verified. A proficiency benchmark was established based on the mean performance of an experienced group of arthroscopic shoulder surgeons. CLINICAL RELEVANCE: Validated procedural metrics combined with the use of a cadaveric shoulder can be used to accurately assess the performance of an ARCR.
Asunto(s)
Artroscopía/métodos , Lesiones del Manguito de los Rotadores/cirugía , Manguito de los Rotadores/cirugía , Articulación del Hombro/cirugía , Cadáver , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Grabación en VideoRESUMEN
In-office needle arthroscopy (IONA) has been around for many years, and technological improvements in image fidelity, patient convenience and access to care, and medical economics have resulted in renewed interest in this diagnostic tool. Patients could be well served by an immediate diagnosis of their joint pathology at the initial office encounter. A limitation of the current literature is that for research purposes, studies comparing IONA with diagnostic surgical arthroscopy and/or magnetic resonance imaging have been performed in the operating room-not the office setting. In addition, IONA is limited to intra-articular evaluation. IONA has been shown to be accurate and cost-effective, and future adoption of this modality seems promising.
Asunto(s)
Artroscopía , Agujas , Análisis Costo-Beneficio , Humanos , Imagen por Resonancia MagnéticaRESUMEN
PURPOSE: To determine whether needle arthroscopy (NA) compared with magnetic resonance imaging (MRI) in the diagnosis and treatment of meniscal tears is cost-effective when evaluated over a 2-year period via patient-reported outcomes. The hypothesis is that improved diagnostic accuracy with NA would lead to less costly care and similar outcomes. METHODS: A Markov model/decision tree analysis was performed using TreeAge Pro 2017 software. Patients were evaluated for degenerative and traumatic damage to the lateral/medial meniscus. Assumed sensitivities and specificities were derived from the medical literature. The direct costs for care were derived from the 2017 Medicare fee schedule and from private payer reimbursement rates. Costs for care included procedures performed for false-positive findings and for care for false-negative findings. Effectiveness was examined using the global knee injury and osteoarthritis outcome score (KOOS). Patients were evaluated over 2 years for costs and outcomes, including complications. Dominance and incremental cost-effectiveness were evaluated, and 1- to 2-way sensitivity analysis was performed to determine those variables that had the greatest effect. The consolidated economics evaluation and reporting standards checklist for reporting economic evaluations was used. RESULTS: NA was less costly and had similar KOOS versus MRI for both the medial/lateral meniscus with private pay. Costs were less for both Medicare and private pay for medial meniscus, $780 to $1,862, and lateral meniscus, $314 to $1,256, respectively. CONCLUSIONS: Based on the reported MRI incidence of false positives with the medial meniscus and false negatives with the lateral meniscus and based on assumed standards of care, more costly care is provided when using MRI compared with NA. Outcomes were similar with NA compared with MRI. LEVEL OF EVIDENCE: Level II, economic and decision analysis.
Asunto(s)
Artroscopía/economía , Costos de la Atención en Salud/estadística & datos numéricos , Traumatismos de la Rodilla/diagnóstico , Imagen por Resonancia Magnética/economía , Lesiones de Menisco Tibial/diagnóstico , Adulto , Artroscopía/métodos , Análisis Costo-Beneficio , Técnicas de Apoyo para la Decisión , Femenino , Humanos , Traumatismos de la Rodilla/economía , Traumatismos de la Rodilla/terapia , Imagen por Resonancia Magnética/métodos , Masculino , Medicare , Meniscos Tibiales/diagnóstico por imagen , Persona de Mediana Edad , Modelos Econométricos , Agujas , Medición de Resultados Informados por el Paciente , Sensibilidad y Especificidad , Lesiones de Menisco Tibial/economía , Lesiones de Menisco Tibial/terapia , Estados UnidosRESUMEN
PURPOSE: To collect outcomes data on patients treated with a bioinductive collagen implant designed to induce rotator cuff healing in partial- and full-thickness cuff tears and to assess the safety and efficacy of the device. METHODS: Fifteen surgeons in 15 centers in the United States enrolled patients between April 2016 and August 2017 and collected standardized outcomes data. Patients 21 years of age and older, able to read and speak English, and with partial- or full-thickness tears of the rotator cuff documented by magnetic resonance imaging were included in the study. Patients were assessed preoperatively with visual analogue scale (VAS), single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcomes measures. Postoperative assessment was made at 2, 6, and 12 weeks, 6 months, and 1 year. Patients underwent a standardized operative procedure with the implant. Patient demographics, comorbidities, tear types, and concomitant operative procedures were recorded. RESULTS: Patients in both groups experienced statistically significant improvement in VAS, SANE, VR-12 PCS, ASES, and WORC scores (mean values 1.1, P < .001; 86.0, P < .001; 49.7, P < .001; 85.6, P < .001; and 84.4, P < .001 for partial tears and 1.2, P < .001; 80.7, P < .001; 45.7, P < .001; 83.8, P < .0001; and 80.1, P < .001 for full-thickness tears, respectively). For the partial tear group, average times for return to driving, work, and nonoverhead athletic activity were 14.6, 37.3, and 65.6 days, and for the full-thickness group, 24.5, 50.7, and 119.2 days, respectively. In the partial-thickness group, 84% and 83% of patients reported improvement in their VAS pain and ASES scores, respectively, that met or exceeded each measure's minimal clinically important difference. In the full-thickness group, 72% and 77% of the patients met or exceeded the minimal clinically important differences for VAS pain and ASES, respectively. CONCLUSION: Outcomes after repair of partial- and full-thickness rotator cuff tears using a bioinductive implant show safety and efficacy at 1-year follow-up. LEVEL OF EVIDENCE: Retrospective case series, level IV evidence.
Asunto(s)
Implantes Absorbibles , Colágeno/uso terapéutico , Medición de Resultados Informados por el Paciente , Lesiones del Manguito de los Rotadores/cirugía , Manguito de los Rotadores/cirugía , Adulto , Anciano , Artroscopía , Femenino , Humanos , Laceraciones/patología , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Estudios Retrospectivos , Rotura/cirugía , Hombro , Resultado del Tratamiento , Estados Unidos , Escala Visual Analógica , Adulto JovenRESUMEN
A considerable body of literature with high-level evidence has been published in the past 15 years calling into question the value of arthroscopic surgery in treating osteoarthritis of the knee (OAK). This, plus recent guidelines advising against the use of conservative treatments such as hyaluronic viscosupplementation, threatens to limit patient access to treatment for a chronic disease state with no known cure. The disease burden of OAK is considerable and represents one of the largest health care dollar expenditures in the United States and the world. Orthopaedic surgeons are the primary specialty dealing with OAK and manage this disease from inception to the final endpoint of total joint arthroplasty. As the population ages and the incidence of OAK increases, we must find ways to improve our ability to show efficacy in our treatments and also promote innovative modalities and applications to ameliorate the disability and dysfunction associated with OAK. Arthroscopy is recognized as a global leader in the presentation of evidence and debate surrounding all treatments for OAK and plays an important role in improving knowledge and treatment efficacy.
Asunto(s)
Tratamiento Conservador , Osteoartritis de la Rodilla , Artroscopía , Humanos , Articulación de la Rodilla , Estudios Retrospectivos , ViscosuplementaciónRESUMEN
Recent trends indicate that a greater number of orthopaedic surgeons who complete their residency and/or fellowship training are accepting employment positions at hospitals. Moreover, established orthopaedic surgeons with successful private practices have begun to consider whether aligning with hospitals and larger health systems can be effectively accomplished. A comprehensive evaluation of institution-based employment opportunities is essential for orthopaedic surgeons considering hospital-based employment. Surgeons should be aware of the healthcare, clinical, and administrative opportunities of private practice employment versus hospital-based employment before accepting a clinical position.
RESUMEN
Patient-centered medicine requires an informed health care consumer. Traditionally, orthopaedic surgeons were the primary source for patients regarding diagnostic and treatment options for musculoskeletal conditions. Now patients get information from a variety of sources including the Internet, social media, and print journalism. Most of these sources are not vetted or peer reviewed and some not even fact checked. Part of the role of the orthopaedic surgeon is to educate patients, and interpreting this type of information is an increasingly demanding but essential task. A recent article in the New York Times titled "Why 'Useless' Surgery Is Still Popular" illustrates the importance of this educational role. Patients deserve the most up-to-date and accurate assessment of medical information. The most appropriate source of that information is their treating physician and surgeon.
Asunto(s)
Investigación Biomédica , Medios de Comunicación de Masas , Ortopedia , Educación del Paciente como Asunto , Rol del Médico , Investigación Biomédica/normas , Humanos , Internet , Periodismo Médico , Medios de Comunicación SocialesRESUMEN
For the past 24 years, most developed countries have used the International Classification of Diseases, Tenth Revision (ICD-10) to report physician services. In the United States, physicians have continued to use the American Medical Association Current Procedural Terminology, Fourth Edition and the Healthcare Common Procedure Coding System. The ICD-10-Clinical Modification (CM) has approximately 4.9 times more codes than the International Classification of Diseases, Ninth Revision. ICD-10-CM allows for more specific descriptors of a procedure and is broken down by category, etiology, anatomic site, severity, and extension. ICD-10-CM is scheduled to be implemented by Medicare and commercial payers on October 1, 2015. In addition to ICD-10 implementation, physicians have to meet the requirements of the Meaningful Use Electronic Health Record Incentive Program. The Meaningful Use program is designed to promote the use of certified electronic health technology by providing eligible professionals with incentive payments if they meet the defined core and menu objectives of each stage of the program. All core measures must be met; however, providers can choose to meet a preset number of menu measures. Meaningful Use Stage 1 required eligible professionals to meet core and menu objectives that focused on data capture and sharing. Meaningful Use Stage 2 requires eligible professionals to meet core and menu objects that focus on advanced clinical processes for a full year in 2015. Stage 3 has been delayed until 2017, and core and menu measures that will focus on improving outcomes have not yet been defined. It is important for orthopaedic surgeons to understand the history of and techniques for the use of ICD-10-CM in clinical practice. Orthopaedic surgeons also should understand the requirements for Meaningful Use Stages 1 and 2, including the core objectives that must be met to achieve satisfactory attestation.
Asunto(s)
Clasificación Internacional de Enfermedades , Uso Significativo/tendencias , Ortopedia/métodos , Humanos , Clasificación Internacional de Enfermedades/organización & administración , Clasificación Internacional de Enfermedades/tendencias , Pautas de la Práctica en Medicina/normas , Mejoramiento de la Calidad , Estados UnidosRESUMEN
PURPOSE: To determine the effectiveness of proficiency-based progression (PBP) training using simulation both compared with the same training without proficiency requirements and compared with a traditional resident course for learning to perform an arthroscopic Bankart repair (ABR). METHODS: In a prospective, randomized, blinded study, 44 postgraduate year 4 or 5 orthopaedic residents from 21 Accreditation Council for Graduate Medical Education-approved US orthopaedic residency programs were randomly assigned to 1 of 3 skills training protocols for learning to perform an ABR: group A, traditional (routine Arthroscopy Association of North America Resident Course) (control, n = 14); group B, simulator (modified curriculum adding a shoulder model simulator) (n = 14); or group C, PBP (PBP plus the simulator) (n = 16). At the completion of training, all subjects performed a 3 suture anchor ABR on a cadaveric shoulder, which was videotaped and scored in blinded fashion with the use of previously validated metrics. RESULTS: The PBP-trained group (group C) made 56% fewer objectively assessed errors than the traditionally trained group (group A) (P = .011) and 41% fewer than group B (P = .049) (both comparisons were statistically significant). The proficiency benchmark was achieved on the final repair by 68.7% of participants in group C compared with 36.7% in group B and 28.6% in group A. When compared with group A, group B participants were 1.4 times, group C participants were 5.5 times, and group C(PBP) participants (who met all intermediate proficiency benchmarks) were 7.5 times as likely to achieve the final proficiency benchmark. CONCLUSIONS: A PBP training curriculum and protocol coupled with the use of a shoulder model simulator and previously validated metrics produces a superior arthroscopic Bankart skill set when compared with traditional and simulator-enhanced training methods. CLINICAL RELEVANCE: Surgical training combining PBP and a simulator is efficient and effective. Patient safety could be improved if surgical trainees participated in PBP training using a simulator before treating surgical patients.
Asunto(s)
Artroscopía/educación , Competencia Clínica , Internado y Residencia , Entrenamiento Simulado/métodos , Adulto , Artroscopía/normas , Curriculum , Educación de Postgrado en Medicina , Humanos , Masculino , Persona de Mediana Edad , América del Norte , Ortopedia/educación , Estudios Prospectivos , Hombro/cirugía , Articulación del Hombro/cirugía , Anclas para SuturaRESUMEN
The purpose of this study was to evaluate the economic attributes of private practice adult reconstruction (AR) offices. 458 AAHKS surgeons responded; 65% were in private practice (fee-for-service, non-salaried, non-employed AR surgeons). 54% had considered hospital employment in the past two years. The average group employs 13.4 orthopedic surgeons (3.4 AR), and 105 other employees. The average total budget is $12.5 million per year with $4 million in salaries, and $238,000 in tax revenue generated. Co-management joint ventures are a better model than hospital employment for aligning AR surgeons and hospitals and realizing the cost effectiveness and quality improvement goals of PPACA and AARA while preserving the economic impact of AR private practice.
Asunto(s)
Atención a la Salud/economía , Convenios Médico-Hospital/economía , Cuerpo Médico de Hospitales/economía , Procedimientos Ortopédicos/economía , Ortopedia/economía , Práctica Privada/economía , Adulto , Artroplastia de Reemplazo/economía , Empleo/economía , Reforma de la Atención de Salud/economía , Encuestas de Atención de la Salud , Humanos , Médicos/economía , Consultorios Médicos/economía , Procedimientos de Cirugía Plástica/economía , Encuestas y Cuestionarios , Estados UnidosRESUMEN
The American Academy of Orthopaedic Surgeons (AAOS) 2013 guidelines for knee osteoarthritis recommended against the use of viscosupplementation for failing to meet the criterion of minimum clinically important improvement (MCII). However, the AAOS's methodology contained numerous flaws in obtaining, displaying, and interpreting MCII-based results. The current state of research on MCII allows it to be used only as a supplementary instrument, not a basis for clinical decision making. The AAOS guidelines should reflect this consideration in their recommendations to avoid condemning potentially viable treatments in the context of limited available alternatives.
Asunto(s)
Ortopedia/normas , Osteoartritis de la Rodilla/terapia , Guías de Práctica Clínica como Asunto/normas , Viscosuplementación , Academias e Institutos , Contraindicaciones , Medicina Basada en la Evidencia/normas , Humanos , Mejoramiento de la Calidad/normas , Estados Unidos , Viscosuplementación/normasRESUMEN
We propose using appropriate-use criteria (AUC) as the methodology of choice for formulating and disseminating evidence-based medicine guidelines in sports medicine and arthroscopy. AUC provide a structured process for integrating findings from the scientific literature with clinical judgment to produce explicit criteria for determining the appropriateness of specific treatments. The use of AUC will enable surgeons to treat patients in a more consistent manner based on expert clinical consensus and evidence-based medicine. This methodology also will ensure that guidelines represent all stakeholders and available evidence.
Asunto(s)
Artroscopía/normas , Medicina Basada en la Evidencia/métodos , Guías de Práctica Clínica como Asunto/normas , Mejoramiento de la Calidad/normas , Medicina Deportiva/normas , Consenso , Medicina Basada en la Evidencia/normas , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Mecanismo de Reembolso/normasRESUMEN
Purpose: This study was conducted to investigate whether the use of resorbable bioinductive collagen implant (RBI) in addition to conventional rotator cuff repair (conventional RCR) is cost-effective when compared to conventional RCR alone, in the treatment of full-thickness rotator cuff tears (FT RCT). Methods: We developed a decision analytic model to compare the expected incremental cost and clinical consequences for a cohort of patients with FT RCT. The probabilities for healing or failure to heal (retear) were estimated from the published literature. Implant and healthcare costs were estimated from a payor's perspective in 2021 U.S. prices. An additional analysis included indirect cost estimations (e.g., productivity losses). Sensitivity analyses explored the effect of tear size, as well as the impact of risk factors. Results: The base case analysis demonstrated that resorbable bioinductive collagen implant + conventional rotator cuff repair results in incremental costs of $232,468 and an additional 18 healed RCTs per 100 treated patients over 1 year. The estimated incremental cost-effectiveness ratio (ICER) is $13,061/healed RCT compared to conventional RCR alone. When return to work was included in the model, RBI + conventional RCR was found to be cost saving. Cost-effectiveness improved with tear size with the largest benefit seen in massive tears compared to large tears, as well as patients at higher risk of retearing. Conclusions: This economic analysis demonstrated that RBI + conventional RCR delivered improved healing rates at a marginal increase in costs when compared to conventional RCR alone and is, therefore, cost-effective in this patient population. Considering indirect costs, RBI + conventional RCR resulted in lower costs compared to conventional RCR alone and is, therefore, deemed to be cost saving. Level of Evidence: Level IV, economic analysis.
RESUMEN
Knee osteoarthritis (KOA) is a debilitating disease characterized by chronic pain, stiffness, and decreased mobility. Intra-articular injectable therapies show good clinical efficacy in improving symptoms; however, these therapies and their comparators (intra-articular saline) have been associated with a large underlying placebo effect. We aimed to describe the existing evidence on the challenges, hypotheses, and potential solutions to mitigate the intra-articular placebo effect in clinical trials in KOA. A targeted literature review was conducted by searching Embase, MEDLINE®, and CENTRAL using predefined study selection criteria. All eligible studies identified were extracted for relevant data, and results were narratively summarized. Forty-three studies were included following screening. Challenges associated with the intra-articular placebo effect included its ability to mask the comparative efficacy of active treatments in trials (n = 7 studies), long-lasting effects (up to 6 months; n = 3), and substantial variation of placebo effect sizes across populations (n = 3). Hypotheses for the mechanism of the placebo effect included aspiration of synovial fluid during administration (n = 6) and dilution of inflammatory mediators (n = 2). Factors affecting the placebo effect size were more invasive routes of administration (e.g., injection versus oral; n = 4) and patient expectations (n = 2). Proposed solutions included the suggestion for readers to weigh the relevance of clinical trial evidence against the presence of large underlying placebo effects (n = 9), discontinuation of intra-articular saline as an appropriate placebo (n = 5), and inclusion of 'no treatment' or sham injection as a control (n = 4). The intra-articular placebo effect is a well-documented occurrence in KOA clinical trials, and it is suggested that it be accounted for when designing randomized controlled trials. Awareness and understanding of the intra-articular placebo effect in KOA are required for fair interpretation of clinical trial evidence.