Micro-fragmented adipose tissue (mFAT) associated with arthroscopic debridement provides functional improvement in knee osteoarthritis: a randomized controlled trial.

PURPOSE: Current conservative treatments for knee OA provide limited benefits, with symptoms relief for a short amount of time. Regenerative medicine approaches such as the use of microfragmented adipose tissue (mFAT) showed promising results in terms of durable effects and the possibility to enhance tissue healing and counteract the progression of the pathology. Nevertheless, up to today, the large part of clinical data about mFAT use refers to uncontrolled studies, especially in the surgical setting. The purpose of this study was to evaluate the effectiveness of mFAT applied in association with arthroscopic debridement (AD) for the treatment of knee OA, in terms of symptoms relief and tissue healing. METHODS: This study is a prospective, randomized controlled clinical trial. 78 patients affected by knee OA grade 3-4 according to KL classification were randomly assigned to AD or AD + mFAT treatment groups. Clinical, radiological and serological assessments were performed at 6 months after treatment. Additional clinical evaluation was performed at the end of the study with an average follow-up of 26.1 ± 9.5 months. VAS, KOOS, WOMAC and SF-12 were also collected at both timepoints, KSS only at 6 months. RESULTS: Treatment with AD + mFAT improved functional scores at both 6 months (KOOS-PS: + 11.7 ± 20.2 vs + 24.4 ± 22.5, in AD and AD + mFAT, respectively, p = 0.024; KSS: + 14.9 ± 15.9 vs + 24.8 ± 23.5, in AD and AD + mFAT, respectively, p = 0.046) and 24-month follow-ups (KOOS-PS Functional subscale: - 2.0 ± 3.5 vs - 4.7 ± 4.2, in AD and AD + mFAT, respectively, p = 0.012). Lower T2-mapping scores were obtained in AD + mFAT-treated group in medial and lateral condyle compartments (p < 0.001). Slight increase was observed in the levels of a serum biomarker of cartilage deposition (PIIINP) in both groups at 6-month follow-up (p = 0.037). CONCLUSION: mFAT improves functional outcome and MRI appearance when used in association with AD, therefore supporting its use in the treatment of knee OA in an arthroscopic setting.

Italian Translation, Adaptation, and Validation of the Novel Satisfaction Measure Assessment after Primary Total Joint Arthroplasty: The Goodman Score Questionnaire.

Patient satisfaction after total joint arthroplasties (TJA) represents a key element for the evaluation of surgery success in relation to subjects' needs and expectations. The assessment tools are applied inconsistently throughout the literature, and thus, it is difficult to compare results among different studies. Goodman et al. proposed a standardized questionnaire with strong psychometric properties for the assessment of satisfaction. The present study aims to translate, adapt, and validate the Goodman questionnaire for the Italian population. After translation and back translation, the questionnaire was administrated to 50 patients. Internal consistency, test-retest reliability, floor and ceiling effects, and construct validity were evaluated (correlation with KOOS/HOOS, SF-12 PCS/MCS, EQ-5D). Responsiveness was evaluated with respect to SF-12 PCS improvements. The Italian version of the Goodman score questionnaire demonstrated psychometric properties similar to those of the original version. The translated questionnaire showed good internal consistency (Cronbach's alpha = 0.836) and test-retest reliability (ICC: 0.507). Moderate/strong correlations were observed between the Italian version of the Goodman score and other scores. The score significantly discriminated patients who improved from those who did not improve in SF-12 PCS after treatment. This study provides an adapted and validated Italian version of the Goodman score questionnaire, with psychometric properties similar to those of its original counterpart.

Remote Management of Patients after Total Joint Arthroplasty via a Web-Based Registry during the COVID-19 Pandemic.

BACKGROUND: In 2020, due to the outbreak of the COVID-19 (Coronavirus Disease 2019) pandemic, patients who underwent total joint arthroplasty were not able to undergo the proper postoperative surgical and rehabilitative care. This study aims to evaluate the potential of a web-cloud-based database on patients' follow-up in extraordinary situations, when a traditional in-person follow-up cannot be warranted. METHODS: Patients who underwent joint arthroplasty at our Institute between 21 February and 16 March 2020 were included in the study group and were matched to a similar population undergoing joint arthroplasty in February/March 2019. All patients routinely complete questionnaires before and after treatment, including patient-reported outcome measures such as the Visual Analogues Scale (VAS), Knee/Hip Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS/HOOS-PS) and Short-Form Health Survey (SF-12) for the monitoring of clinical improvements. RESULTS: 56 (study group) and 144 (control group) patients were included in the study. Both groups demonstrated significant improvements at 3 months. HOOS-PS improvement was significantly reduced in the 2020 group compared to 2019 (21.7 vs. 33.9, p < 0.001). This reduction was related to intense physical activities. Similarly, the functional score improvement related to these activities was reduced for patients undergoing knee replacement (8 vs. 10, p < 0.05). CONCLUSIONS: The web-based Institute Registry emerged as a meaningful and sensitive tool during an extraordinary situation such as the COVID-19 pandemic to monitor patients' progression after total joint arthroplasties. Thanks to this tool, it was possible to observe that the prevention of usual postoperative care due to pandemic-related restrictions did not alter the benefits observed after joint replacement surgeries, even if this condition reduced the postoperative improvements in the most burdensome physical activities. A broader use of this kind of tool would improve and potentially reduce the burden and costs of postoperative patients' monitoring in standard and extraordinary conditions. In addition, the systematic remote collection of data would allow for the identification of relevant differences in clinical outcomes in specific conditions or following the modification of treatment and rehabilitation protocols.

Direct superior approach versus posterolateral approach in total hip arthroplasty: a randomized controlled trial on early outcomes on gait, risk of fall, clinical and self-reported measurements.

Background and purpose - Several surgical approaches are used in primary total hip arthroplasty (THA). In this randomized controlled trial we compared gait, risk of fall, self-reported and clinical measurements between subjects after direct superior approach (DSA) versus posterolateral approach (PL) for THA.Patients and methods - Participants with DSA (n = 22; age 74 [SD 8.9]) and PL (n = 23; age 72 [7.7]) underwent gait analysis, risk of fall assessment and Timed Up and Go Test (TUG) before (PRE), 1 month (T1) and 3 months after (T3) surgery. Data on bleeding and surgical time was collected.Results - DSA resulted in longer surgical times (90 [14] vs. 77 [20] min) but lower blood loss (149 [66] vs. 225 [125] mL) than PL. DSA had lower risk of fall at T3 compared with T1 and higher TUG scores at T3 compared with T1 and PRE. PL improved balance at T3 compared with T1 and PRE. Spatiotemporal gait parameters improved over time for both DSA and PL with no inter-group differences, whereas DSA, regarding hip rotation range of motion, showed lower values at T3 and T1 compared with PRE and, furthermore, this group had lower values at T1 and T3 compared with PL. All foregoing comparisons are statistically signficant (p < 0.05)Interpretation - DSA showed longer surgical time and lower blood loss compared with PL and early improvements in TUG, spatiotemporal, and kinematic gait parameters, highlighting rapid muscle strength recovery.

Opportunities to improve feasibility, effectiveness and costs associated with a total joint replacements high-volume hospital registry.

BACKGROUND: Clinical registries are powerful tools for collecting uniform data longitudinally, thus making it possible to evaluate the outcome of patients affected by a specific pathology. In the context of total joint arthroplasty, registries serve also as post-market surveillance. Adoption of registries is a heavy burden for clinical settings in terms of resources and infrastructures. Excessive workload leads to incomplete data collection which undermines the effectiveness of a registry and consequently the workload needs to be optimised. METHODS: Starting from the use case of the Istituto Ortopedico Galeazzi, the time and personnel dedicated to the registry was estimated. Analysis of the data collected in the first years enabled us to propose a methodology for workload reduction. Different Machine Learning models were leveraged to predict patients with excellent satisfaction to reduce the number of assessments in their clinical post-operative follow-up. Moreover, feature selection was used to identify any unnecessary clinical scale to collect. RESULTS: Given an acceptance rate of 3500 patients per year, 22 doctors and 6 non-medical employees were required to adopt a registry properly. Among the tested models, the Naïve Bayes gave the best performance (AUPRC = 0.81) in predicting patient satisfaction at six months. Moreover, we found that the 12-item Short Form was poorly informative in predicting satisfaction at six-months. CONCLUSIONS: In this study machine learning was leveraged to provide a methodology to reduce workload in the use of pathology registries. Such workload reduction can have a considerable impact at a larger scale, and improve registry feasibility in high-volume hospitals.

Intraoperative validation of bone cut accuracy of a pinless smart touch-screen navigation system device in total knee arthroplasty.

PURPOSE: Primary objective in most of the published literature on computer-assisted total knee arthroplasty (TKA) has so far been the comparison of axial alignment and components position, obtained either through navigation systems or through conventional instrumentation. We have found no studies aimed at assessing the intraoperative reliability of a navigation system in relation to bone cuts height. Aim of our study was therefore to establish bone cut accuracy of a pinless navigation system. METHODS: From January 2014 to February 2016, 44 consecutive patients requiring total knee replacement (TKR) were enrolled in a prospective study. Primary end point of the study was to assess the accuracy of the DASH iPOD TOUCH Navigation System (Brainlab AG, Feldkirchen, Germany) by measuring the real thickness of both tibial and femoral osteotomies. We compared the data indicated by the navigation system with the intraoperative anatomical measurements done with the aid of a caliper. In addition, the radiographic alignment was compared with the data derived from the navigator. RESULTS: The device proved to be precise. Differences between the two methods of measurement are distributed over a millimeter range. Radiological measurements showed that 95.5% of tibial components were within the range of 3° varus/valgus; same results were obtained by the navigation system; instead, 90.1% of femoral components were within the range of 3° varus/valgus based on the radiological measurement, whereas according to the navigation system, 86.4% were in this range. CONCLUSIONS: The DASH iPOD TOUCH Navigation System is a precise and reliable instrument to assist in TKA navigation.

Clinical Performance, Patient Reported Outcome, and Radiological Results of a Short, Tapered, Porous, Proximally Coated Cementless Femoral Stem: Results up to Seven Years of Follow-Up.

BACKGROUND: The primary aim of our study was to assess clinical performance, patient reported outcome and radiological results of cementless primary total hip arthroplasty using Tri-Lock Bone Preservation Stem. METHODS: Between March 2010 and June 2012, 163 consecutive patients, were enrolled in the study. Patients were assessed clinically and radiographically prior to surgery as well as at 6, 12, 24 months and then at 5, 6, and 7 years postoperatively. RESULTS: Using the Dorr classification, 39 patients (23.9%) were classified as Dorr A, 116 patients (71.2%) as Dorr B, and 8 patients (4.9%) as Dorr C. A total of 139 patients (85.3%) received a high offset, whereas 24 patients (14.7%) received a standard offset stem. Total Harris Hip Score of the patients increased from a mean of 27.29 (±4.6) preoperatively, upto 97.28 (±9.0) after 5 years. Mean preoperative Short Form-12 (SF-12) Physical Health Composite Scale score was 27.31 (±3.8). After 5 year was 55.3 (34-57). The mean preoperative SF-12 Mental Health Composite Scale score was 57.02 (±5.9). After 5 year was 59.3 (28.7-60.8). Only one patient underwent revision surgery for dislocation and revision of the head. CONCLUSION: Tri-lock Bone Preservation Stem DePuy proved to be an easy-to-use device. Results obtained up to 7 years of FU show excellent clinical performance, as well as radiographic osseointegration, with no cases of aseptic loosening and no images of progressive radiolucent lines or periprosthetic osteolysis.

Survivorship at minimum 10-year follow-up of a rotating-platform, mobile-bearing, posterior-stabilised total knee arthroplasty.

PURPOSE: To evaluate prospectively the long-term clinical and radiographic results and survivorship of a rotating-platform, posterior-stabilised knee prosthesis at minimum 10 years (mean 11.5 ± 1.41 years), and to test the hypothesis that this design would have a mechanical survivorship greater than 95%. METHODS: Between 2000 and 2002, 160 consecutive patients (166 knees) underwent total knee arthroplasty using a rotating-platform, posterior-stabilised prosthesis, and clinical and radiographic follow-up data were gathered prospectively. RESULTS: One hundred and seven patients (112 knees) were available for final follow-up. Five patients (3%) had undergone revision surgery, giving a Kaplan-Meier survival rate of 96.6% for all causes of failure. No spin-out of the polyethylene insert was observed. The mean visual analogue scale, Knee Society and Oxford Knee Scores showed statistically significant improvements (p < 0.001). On radiographs, two cases (2.4%) had radiolucent lines >2 mm, and no patient had osteolysis. CONCLUSIONS: The absence of osteolysis at minimum 10 years seems to support our hypothesis that this design may be able to reduce peri-prosthetic bone resorption in the long term. The survivorship was greater than 95% and is comparable to the best results reported for this type of knee prosthesis in the literature. The clinical scores are reasonable, given the presence of various disabling concomitant pathologies and the relatively advanced mean age of the study population. This study is clinically relevant because it adds valuable information to the limited data regarding the long-term survivorship and performance of rotating-platform knee prostheses and, more specifically, of a single knee design. LEVEL OF EVIDENCE: IV.

Minimum 10 year survivorship analysis of a partially coated hydroxyapatite tapered femoral stem in elderly patients with an average age over 75.

This is a retrospective, non-comparative study of 212 consecutive patients who underwent Total Hip Arthroplasty with an uncemented hydroxyapatite (HA) coated stem system from November 1997 to March 2000. The objective of the study was to analyze the performance of the implant at a minimum of 10 years in older patients (mean age 79.6 years). The Kaplan-Meier survivorship of the femoral stem at 10 years was 100%, and 97.5% for the whole prosthesis. The mean Merle d'Aubigné clinical score improved from 4.4 ± 2.1 points pre-operatively to 13.39 ± 3.77 points at final follow-up (p<0.05), and the mean VAS score for thigh pain was 1.25. The radiographic analysis showed that there were no significant radiolucent lines or osteolysis compromising the fixation of the implant.