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Background Medicare is rapidly moving toward using patient-reported outcome measures (PROMs) for outcomes assessment and justification of orthopaedic and other procedures. Numerous measures have been developed to study knee osteoarthritis (OA); however, many of these surveys are long, disruptive to clinic flow, and result in incomplete data capture and/or low followup rates. The Knee injury and Osteoarthritis Outcome (KOOS) physical function short-form (KOOS-PS), while shorter, ignores pain, which is a primary concern of patients with advanced knee OA. Questions/purposes Our objective was to derive and validate a short-form survey focused on the patient with end-stage knee OA undergoing TKA. Methods Using our hospital’s knee replacement registry, we retrospectively identified 2291 patients with knee OA who underwent primary unilateral TKA and had completed preoperative and 2-year postoperative PROMs. We assessed 30 items from the 42-item KOOS that were quantitatively most difficult for patients to perform before TKA and qualitatively most relevant to patients with end-stage knee OA. Rasch analysis identified the KOOS, JR, a seven-item instrument, representing a single dimension, which we define as “knee health” because it reflects aspects of pain, symptom severity, and activities of daily living (ADL) including movements or activities that are directly relevant and difficult for patients with advanced knee OA. We assessed the internal consistency, external validity (versus KOOS and WOMAC domains), responsiveness, and floor and ceiling effects of the KOOS, JR. External validation was performed using calculated KOOS, JR scores in collaboration with a nationally representative joint replacement registry, the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR). Results Internal consistency for the KOOS, JR was high (Person Separation Index, 0.84; and 0.85 [FORCE]), external validity against other validated knee surveys was excellent (Spearman correlation coefficient, ρ 0.54–0.91), particularly for the KOOS pain (ρ 0.89 [95% CI, 0.88–0.91] Hospital for Special Surgery [HSS]; and 0.91 [95% CI, 0.90–0.93] [FORCE]) and KOOS ADL (ρ 0.87 [95% CI, 0.85–0.88] [HSS]; and 0.84 [95% CI, 0.81–0.87] [FORCE]). The KOOS, JR responsiveness (standardized response means, 1.79 [95% CI, 1.70–1.88] [HSS]; and 1.70 [95% CI, 1.54–1.86] [FORCE]) was high and floor 0.4–1.2%) and ceiling (18.8–21.8%) effects were favorable. Conclusions The new short knee PROM, the KOOS, JR, provides a single score representing “knee health” as it combines pain, symptoms, and functional limitations in a single score. This short-form PROM is patient-relevant and efficient. Level of Evidence Level III, diagnostic study.

IntroductionThe relationship between postoperative tibiofemoral ligament balance and patient satisfaction in total knee arthroplasty (TKA) has been explored previously. However, the optimal intraoperative medial–lateral ligament balance during knee flexion in terms of postoperative patient satisfaction remains unknown. We evaluated the effect of intraoperative flexion instability on patient satisfaction after TKA.Materials and methodsThis study consisted of 46 knees with varus osteoarthritis undergoing TKA. Medial–lateral component gaps at 0° knee extension and 90° flexion were measured intraoperatively using a knee balancer. Differences in postoperative patient outcomes at 3 weeks and 1 year were compared between medially tight knees in 90° flexion with a medial component gap of < 4 mm and medially loose knees in 90° flexion with a gap of ≥ 4 mm. Outcomes were measured using the 2011 Knee Society Scoring System (2011 KS).ResultsThe median total 2011 KS score at 1 year postoperatively in the medially loose knees [median 97; interquartile range (IQR) 75–117] was significantly lower than that in the medially tight knees (median 128; IQR 104–139, P < 0.01), while preoperative and 3-week postoperative scores were similar. In addition, medial flexion gaps were not significantly associated with total 2011 KS scores before surgery or at 3 weeks postoperatively. However, at 1 year after surgery, medial component flexion gaps were negatively associated with the total 2011 KS score (R = − 0.42; P < 0.01) and the 2011 KS satisfaction subscale score (R = − 0.36; P = 0.01).ConclusionsExcessive intraoperative medial joint laxity of ≥ 4 mm at 90° flexion progressively decreased patient satisfaction for 1 year. Since intraoperative medial laxity in flexion is likely to interfere with functional recovery after TKA, medial stabilization during TKA is important throughout knee flexion.Level of evidenceTherapeutic study, Level III.

Purpose Achieving a balanced knee is accepted as an important goal in total knee arthroplasty; however, the definition of ideal balance remains controversial. This study therefore endeavoured to determine: (1) whether medio-lateral gap balance in extension, midflexion, and flexion are associated with improved outcome scores at one-year post-operatively and (2) whether these relationships can be used to identify windows of optimal gap balance throughout flexion. Methods 135 patients were enrolled in a multicenter, multi-surgeon, prospective investigation using a robot-assisted surgical platform and posterior cruciate ligament sacrificing gap balancing technique. Joint gaps were measured under a controlled tension of 70–90 N from 10°–90° flexion. Linear correlations between joint gaps and one-year KOOS outcomes were investigated. KOOS Pain and Activities of Daily Living sub-scores were used to define clinically relevant joint gap target thresholds in extension, midflexion, and flexion. Gap thresholds were then combined to investigate the synergistic effects of satisfying multiple targets. Results Significant linear correlations were found throughout extension, midflexion, and flexion. Joint gap thresholds of an equally balanced or tighter medial compartment in extension, medial laxity ± 1 mm compared to the final insert thickness in midflexion, and a medio-lateral imbalance of less than 1.5 mm in flexion generated subgroups that reported significantly improved KOOS pain scores at one year (median ∆ = 8.3, 5.6 and 2.8 points, respectively). Combining any two targets resulted in further improved outcomes, with the greatest improvement observed when all three targets were satisfied (median ∆ = 11.2, p  = 0.002). Conclusion Gap thresholds identified in this study provide clinically relevant and achievable targets for optimising soft tissue balance in posterior cruciate ligament sacrificing gap balancing total knee arthroplasty. When all three balance windows were achieved, clinically meaningful pain improvement was observed. Level of Evidence Level II.

Purpose While a wide variety of platelet-rich plasma (PRP) solutions has been developed, innovation continues. In this case, the freeze-dried platelet factor concentrate (PFC-FD) represents another step in PRP refinement. The preparation of PFC-FD at a central laboratory with freeze drying for shelf stabilization should provide additional quality improvements if clinical effectiveness can be demonstrated. Therefore, this study was undertaken to assess the safety and effectiveness of PFC-FD in a prospective open-label trial of patients suffering from knee osteoarthritis (OA). Methods 312 consecutive knee OA patients (67% female, mean age 63 ± 10 years), were prospectively recruited in an outpatient knee clinic in Japan. Of these, 10 (3.2%) were lost to follow-up at < 12 months and 17 (5.5%) sought additional knee therapy during the follow-up period. The primary outcome of interest was achievement of the OMERACT-OARSI responder criteria with secondary outcomes of adverse events and PROMs scores 1, 3, 6, 12 months following a single PFC-FD injection. Results 285 patients (91%) completed 12 month PROMs. The 17 who sought additional therapy were considered failures leaving an effective sample size of 302 for our primary outcome in which 62% of patients achieved OMERACT-OARSI responder status by 12 months. This varied by OA class with Kellgren–Lawrence grade 4 patients 3.6 times less likely to be responders than grade 1–2 patients. 6% of patients experienced a non-serious adverse event, primarily pain or swelling at the injection site. Conclusions PFC-FD provides an observable clinical improvement in 62% of knee OA patients at 12 months post-injection with very little risk of any clinically relevant adverse event. Of course, nearly 40% of patients did not experience an observable clinical improvement, primarily among those with worse KL grades. Level of evidence Therapeutic, Level II.

Purpose The present study aims to translate, adapt and validate a Spanish version of the Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR), including a reliability and validity analysis in patients with knee osteoarthritis (OA). Methods This study conducted a prospective validation study following the six stages of the “Guidelines for the Process of Cross-Cultural Adaptation of Self-Report Measures”. Psychometric testing was conducted in patients with knee osteoarthritis. Subjects answered the Spanish KOOS, JR (S-KOOS, JR) and a validated Spanish Oxford Knee Score (S-OKS). Retest was conducted at 10 days. Acceptability, floor and ceiling effect, internal consistency (Cronbach’s α), reproducibility (mixed-effect model coefficient [MEMC]) and construct validity (Spearman’s correlation; p  = 0.05) were assessed. Results Forty-one patients (mean age: 65.6 ± 5.39; 48.8% female) participated in the study. All patients (100%) answered both scores during the first assessment and 38 (92.7%) during the second assessment. All patient-reported outcomes measures were answered completely (100%). The S-KOOS, JR resulted in 100% acceptability when answered. There were no ceiling or floor effects detected. The Cronbach’s α for the S-KOOS, JR was 0.927 and its MEMC was 0.852 (CI 95% 0.636–1.078). The Spearman’s correlation between the S-KOOS, JR and the S-OKS was 0.711 (CI 0.345–0.608; p  < 0.001) and 0.870 (CI 0.444–0.651; p  < 0.001) for the first and second assessments, respectively. Conclusion The S-KOOS, JR has very high internal consistency and reproducibility, with a high correlation with the S-OKS; it is a reliable and valid instrument for characterising Spanish-speaking patients suffering from knee OA. Level of evidence IV.

Objective To assess the safety and effectiveness of imatinib mesylate in the treatment of diffuse cutaneous systemic sclerosis (dcSSc). Methods In this phase IIa, open-label, single-arm clinical trial, 30 patients with dcSSc were treated with imatinib 400 mg daily. Patients were monitored monthly for safety assessments. Modified Rodnan skin scores (MRSS) were assessed every 3 months. Pulmonary function testing, chest radiography, echocardiography and skin biopsies were performed at baseline and after 12 months of treatment. Results Twenty-four patients completed 12 months of therapy. 171 adverse events (AE) with possible relation to imatinib were identified; 97.6% were grade 1 or 2. Twenty-four serious AE were identified, two of which were attributed to study medication. MRSS decreased by 6.6 points or 22.4% at 12 months (p=0.001). This change was evident starting at the 6-month time point (Δ=−4.5; p<0.001) and was seen in patients with both early and late-stage disease. Forced vital capacity (FVC) improved by 6.4% predicted (p=0.008), and the diffusion capacity remained stable. The improvement in FVC was significantly greater in patients without interstitial lung disease. Health-related quality of life measures improved or remained stable. Blinded dermatopathological analysis confirmed a significant decrease in skin thickness and improvement in skin morphology. Conclusions Treatment with imatinib was tolerated by most patients in this cohort. Although AE were common, most were mild to moderate. In this open-label experience, improvements in skin thickening and FVC were observed. Further investigation of tyrosine kinase inhibition for dcSSc in a double-blind randomised placebo controlled trial is warranted. ClinicalTrials.gov, NCT00555581

IntroductionNew technologies exist which may assist surgeons to better predict final intra-operative joint balance. Our objectives were to compare the impact of (1) a predictive digital joint tensioning tool on intra-operative joint balance; and (2) joint balance and flexion joint laxity on patient-reported outcomes.Materials and methodsTwo-hundred Eighty patients received posterior cruciate ligament sacrificing TKA with ultra-congruent tibial inserts using a robotic-assisted navigation platform. Patients were divided into those in which a Predictive Plan with a digital joint-tensioning device was used (PP) and those in which it was not (NPP), in all cases final post-operative joint gaps were collected immediately before final implantation. Demographics and KOOS were collected pre-operatively. KOOS, complications and satisfaction were collected at 3, 6 and 12 months post-operatively. Optimal balance difference between PP and NPP was defined and compared using area-under-the-curve analysis (AUC). Outcomes were then compared according to the results from the AUC.ResultsAUC analysis yielded a balance threshold of 1.5 mm, in which the PP group achieved a higher rate of balance throughout flexion compared to the NPP group: extension: 83 vs 52%; Midflexion: 82 vs 55%; Flexion 89 vs 68%; Flexion to Extension 80 vs 49%; p ≤ 0.003. Higher KOOS scores were observed in knees balanced within 1.5 mm across all sub-scores at various time points, however, differences did not exceed the minimum clinically important difference (MCID). Patients with > 1.5 mm flexion laxity medially or laterally had an increased likelihood of 2.2 (1.1–4.4) and 2.5 (1.3–4.8), respectively, for failing to achieve the Patient Acceptable Symptom State for KOOS Pain at 12 months. Patient satisfaction was high in both the PP and NPP groups (97.4 and 94.7%, respectively).ConclusionsUse of a predictive joint tensioning tool improved the final balance in TKA. Improved outcomes were found in balanced knees; however, this improvement did not achieve the MCID, suggesting further studies may be required to define optimal balance targets. Limiting medial and lateral flexion laxity resulted in an increased likelihood of achieving the Patient Acceptable Symptom State for KOOS Pain.

The rate of total ankle arthroplasty (TAA) is increasing in the United States as its popularity and indications expand. There currently is no national joint registry available to monitor outcomes, and few studies have addressed the challenges faced with TAA. The purpose of this study was to evaluate the incidence, complications, and survival rates associated with TAA using a large statewide administrative discharge database. Individuals who underwent primary TAA from 1997 to 2010 were identified in the Statewide Planning and Research Cooperative System database from the New York State Department of Health. The age, sex, comorbidities, state of residence, primary diagnosis, and readmissions within 90 days were analyzed for patients with an ICD-9-CM procedure code of 81.56 (TAA). Failure of a TAA implant was defined as revision, tibiotalar arthrodesis, amputation, or implant removal. During the 14-year period, 420 patients underwent 444 TAAs (mean patient age of 61 years, 59% women, mean Charlson-Deyo comorbidity score of 0.45, and 86% New York State residents). The primary diagnosis was 37.4% osteoarthritis, 34.3% traumatic arthritis, and 15.5% rheumatoid arthritis. Surgery for failure was associated only with a younger age (56.5 vs 62 years, P =.005). The rate of subsequent failure procedures following TAAs performed in New York State was 13.8%. The incidence of TAAs is steadily increasing. The overall survival rate in New York State is better than rates reported in other national registries, but it is not yet comparable to those of hip and knee replacements. [ Orthopedics. 2016; 39(3):170–176.]

ObjectivesTo investigate the impact of COVID-19 on the well-being of surgeons and allied health professionals as well as the support provided by their institutions.DesignThis cross-sectional study involved distributing an online survey through medical organisations, social media platforms and collaborators.SettingIt included all staff based in an operating theatre environment around the world.Participants1590 complete responses were received from 54 countries between 15 July and 15 December 2020. The average age of participants was 30–40 years old, 64.9% were men and 32.5% of a white ethnic background. 79.5% were surgeons with the remainder being nurses, assistants, anaesthetists, operating department practitioners or classified other.Main outcome measuresParticipants that had experienced any physical illness, changes in mental health, salary or time with family since the start of the pandemic as well as support available based on published recommendations.Results32.0% reported becoming physically ill. This was more likely in those with reduced access to personal protective equipment (OR 4.62; CI 2.82 to 7.56; p<0.001) and regular breaks (OR 1.56; CI 1.18 to 2.06; p=0.002). Those with a decrease in salary (29.0%) were more likely to have an increase in anxiety (OR 1.50; CI 1.19 to 1.89; p=0.001) and depression (OR 1.84; CI 1.40 to 2.43; p<0.001) and those who spent less time with family (35.2%) were more likely to have an increase in depression (OR 1.74; CI 1.34 to 2.26; p<0.001). Only 36.0% had easy access to occupational health, 44.0% to mental health services, 16.5% to 24/7 rest facilities and 14.2% to 24/7 food and drink facilities. Fewer measures were available in countries with a low Human Development Index.ConclusionsThis work has highlighted a need and strategies to improve conditions for the healthcare workforce, ultimately benefiting patient care.

Black patients are at higher risk of revision total knee replacement (TKR) than White patients, but whether racial disparities exist for both septic and aseptic revision TKR and the reason for any disparities are unknown. To assess the risk of septic and aseptic revision TKR in Black and White patients and to examine interactions among race and socioeconomic and hospital-related variables that are associated with revision TKR risk. This cohort study included residents of New York, California, and Florida who underwent TKR. Patient-level data were obtained from the New York Statewide Planning and Research Cooperative System, California's Office of Statewide Health Planning and Development Patient Discharge Database, and Florida's Healthcare Utilization Project State Inpatient Database from January 1, 2004, to December 31, 2014. Community characteristics were calculated from the US Census and linked to discharges by patient zip code. American Hospital Association Annual Survey data were linked to discharges using hospital identifiers. The analyses were performed from March 1 to October 30, 2020, with subsequent analyses in April 2021. Cox proportional hazards regression modeling was used to measure the association of race with septic and aseptic revision TKR. A total of 722 492 patients underwent primary TKR, of whom 445 616 (61.68%) were female and 61 092 (8.46%) were Black. Black patients were at higher risk of septic (hazard ratio [HR], 1.11; 95% CI, 1.03-1.20) and aseptic (HR, 1.39; 95% CI, 1.33-1.46) revision TKR compared with White patients. Other risk factors for septic revision TKR were diabetes (HR, 1.24; 95% CI, 1.17-1.30), obesity (HR, 1.13; 95% CI, 1.17-1.30), kidney disease (HR, 1.42; 95% CI, 1.29-1.57), chronic obstructive pulmonary disease (HR, 1.22; 95% CI, 1.15-1.30), inflammatory arthritis (HR, 1.53; 95% CI, 1.39-1.69), surgical site complications during the index TKR (HR, 2.19; 95% CI, 1.87-2.56), Medicaid insurance (HR, 1.17; 95% CI, 1.04-1.31), and low annual TKR volume at the hospital where the index TKR was performed (HR, 1.54; 95% CI, 1.41-1.68). Risk factors for aseptic revision TKR were male sex (HR, 1.03; 95% CI, 1.00-1.06), workers' compensation insurance (HR, 1.61; 95% CI, 1.51-1.72), and low hospital TKR volume (HR, 1.14; 95% CI, 1.07-1.22). Patients with obesity had a lower risk of aseptic TKR revision (HR, 0.81; 95% CI, 0.77-0.84). In an analysis within each category of hospital TKR volume, the HR for aseptic revision among Black vs White patients was 1.20 (95% CI, 1.04-1.37) at very-low-volume hospitals (≤89 TKRs annually) compared with 1.68 (95% CI, 1.48-1.90) at very-high-volume hospitals (≥645 TKRs annually). In this cohort study, Black patients were at significantly higher risk of aseptic revision TKR and, to a lesser extent, septic revision TKR compared with White patients. Racial disparities in aseptic revision risk were greatest at hospitals with very high TKR volumes.