A. Boffa (Bologna, IT)
IRCCS Istituto Ortopedico Rizzoli Clinica Ortopedica e Traumatologica 2Presenter Of 3 Presentations
10.2.10 - Leukocyte-Rich Versus Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Trial
Abstract
Purpose
Platelet-rich plasma (PRP) gained a large interest as a minimally invasive treatment for knee osteoarthritis (OA). Different preparation methods are available, and the presence of leukocytes, deemed detrimental from preclinical study results, is one of the most debated aspects regarding PRP efficacy. Aim of this study was to compare safety and effectiveness of Leukocyte-Rich PRP (LR-PRP) and Leukocyte-Poor PRP (LP-PRP) for the treatment of knee OA.
Methods and Materials
A total of 192 patients with symptomatic knee OA (Kellgren-Lawrence 1-3) was randomly allocated to 3 weekly injections of LR-PRP or LP-PRP. LP-PRP was obtained with a filter for leukodepletion. LR-PRP or LP-PRP were divided into aliquots of 5 mL with a mean platelet concentration of 1146.8x109/L and 1074.9x109/L and a mean leukocyte concentration of 7991.4x106/L and 0.1x106/L, respectively (Figure 1). Patients were evaluated at baseline and at 2-6-12 months with IKDC subjective score, KOOS subscales, EQ-VAS, and Tegner scores.
Results
Both LR-PRP and LP-PRP groups reported a significant clinical improvement at all evaluations performed up to 12 months. No differences were observed in terms of absolute values and improvement of the clinical scores at all follow-ups (IKDC subjective: 60.7±21.1 vs 62.9±19.9, respectively - Figure 2). No severe adverse events were described for both groups, while a total of 15 mild adverse events were reported: 4.7% for the LP-PRP and 12.2% for the LR-PRP group, without a statistically significant difference. No statistically significant difference was found between LP-PRP and LR-PRP in terms of failures (3.5%vs7.8%, respectively).
Conclusion
This double-blind RCT showed that three intra-articular LR-PRP or LP-PRP injections provided a significant and similar clinical improvement up to 12 months of follow-up in patients with symptomatic knee OA. Both treatment groups reported a low number of failures and adverse events, without inter-group differences. The presence of leukocytes did not significantly affect the clinical results of PRP injections.
P079 - MCID and PASS in Patients With Knee Osteoarthritis Treated With PRP Injection
Abstract
Purpose
To establish the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptom State (PASS) for the International Knee Documentation Committee (IKDC) Subjective score and the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients treated with platelet-rich plasma (PRP) injections for knee osteoarthritis (OA).
Methods and Materials
This study included 215 patients with knee OA (68% men, 32% women; age, 53.2 ± 11.3 years) who underwent PRP injections. Patients were assessed through the IKDC Subjective score and KOOS subscales, and the MCID and the PASS for both measures were independently calculated at 6 and 12 months post-injection. The MCID was calculated using the value equal to half of the standard deviation of the overall cohort improvement. The PASS was assessed using a 2-point scale (satisfied or not satisfied), with threshold values being detected through a receiver operating characteristic curve analysis and the Youden index to maximize the sensitivity and the specificity of the threshold values.
Results
All scores improved significantly from baseline to 6 months and baseline to 12 months (P < .001 for all scores). All scores were stable from 6 to 12 months except for the KOOS Quality of Life subscale, which improved further (P = .033). For the IKDC, the MCID values were 8.6 and 8.5 points and the PASS scores were 59.7 and 62.1 at 6 and 12 months, respectively. The MCID and the PASS for all KOOS subscales remained constant at the 2 follow-up points. The percentage of patients who achieved the MCID and the PASS was higher than 85% at both 6 and 12 months post-injection.
Conclusion
This study provided the MCID and PASS thresholds for the IKDC and KOOS scores in patients with knee OA treated with PRP injections. These psychometric measures may allow a better interpretation of the clinical relevance of injection-based treatment outcomes for knee OA.
P237 - Adipose-Derived MSCs Injections have Disease-Modifying Effects on Osteoarthritis Progression in Animal Models
Abstract
Purpose
The disease-modifying potential of adipose-derived mesenchymal stromal cells (ADSCs) for the treatment of osteoarthritis (OA) is still not fully established. The aim of this systematic review of preclinical studies was to determine if intra-articular ADSCs can induce disease-modifying effects in OA joints.
Methods and Materials
A systematic review of the literature was performed on animal studies evaluating intra-articular ADSCs injections as treatment for OA joints. A synthesis of the obtained results was performed investigating the ADSCs disease-modifying effects evaluating the studies that compared animals treated with ADSCs and OA controls. Other results were analyzed regarding benefits provided by different ADSCs doses, the effects versus other injectable treatments, and the effects derived from the combination of ADSCs with other products. Risk of bias was assessed according to the SYRCLE’s tool.
Results
Seventy-two studies were included, for a total of 2,058 animals. The publication trend increased over the years (>50% of the articles published from 2018). ADSCs injections provided disease-modifying effects in 92.3% of studies (positive effects on cartilage and/or synovial membrane). In detail, 85.0% reported better macroscopic results, 90.2% better histological results, and 95% better immunohistochemical results, while the 86% reported positive changes in biomarker profile and 78% reported better clinical results compared to OA controls. Evidence was limited on the best ADSCs doses, injection schedule, and comparison with other injectables. A synergistic effect of the combined use with HA was suggested in 5 studies. Risk of bias was low in 38%, unclear in 51%, and high in 11% of items.
Conclusion
ADSCs injections showed disease-modifying effects in most studies. These findings in animal OA models can play a crucial role in understanding mechanisms of action of this biological approach, although high level clinical studies should demonstrate if these results translate into disease-modifying effects when ADSCs are used in the clinical practice to treat OA.
Presenter Of 4 Presentations
P079 - MCID and PASS in Patients With Knee Osteoarthritis Treated With PRP Injection
Abstract
Purpose
To establish the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptom State (PASS) for the International Knee Documentation Committee (IKDC) Subjective score and the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients treated with platelet-rich plasma (PRP) injections for knee osteoarthritis (OA).
Methods and Materials
This study included 215 patients with knee OA (68% men, 32% women; age, 53.2 ± 11.3 years) who underwent PRP injections. Patients were assessed through the IKDC Subjective score and KOOS subscales, and the MCID and the PASS for both measures were independently calculated at 6 and 12 months post-injection. The MCID was calculated using the value equal to half of the standard deviation of the overall cohort improvement. The PASS was assessed using a 2-point scale (satisfied or not satisfied), with threshold values being detected through a receiver operating characteristic curve analysis and the Youden index to maximize the sensitivity and the specificity of the threshold values.
Results
All scores improved significantly from baseline to 6 months and baseline to 12 months (P < .001 for all scores). All scores were stable from 6 to 12 months except for the KOOS Quality of Life subscale, which improved further (P = .033). For the IKDC, the MCID values were 8.6 and 8.5 points and the PASS scores were 59.7 and 62.1 at 6 and 12 months, respectively. The MCID and the PASS for all KOOS subscales remained constant at the 2 follow-up points. The percentage of patients who achieved the MCID and the PASS was higher than 85% at both 6 and 12 months post-injection.
Conclusion
This study provided the MCID and PASS thresholds for the IKDC and KOOS scores in patients with knee OA treated with PRP injections. These psychometric measures may allow a better interpretation of the clinical relevance of injection-based treatment outcomes for knee OA.
P237 - Adipose-Derived MSCs Injections have Disease-Modifying Effects on Osteoarthritis Progression in Animal Models
Abstract
Purpose
The disease-modifying potential of adipose-derived mesenchymal stromal cells (ADSCs) for the treatment of osteoarthritis (OA) is still not fully established. The aim of this systematic review of preclinical studies was to determine if intra-articular ADSCs can induce disease-modifying effects in OA joints.
Methods and Materials
A systematic review of the literature was performed on animal studies evaluating intra-articular ADSCs injections as treatment for OA joints. A synthesis of the obtained results was performed investigating the ADSCs disease-modifying effects evaluating the studies that compared animals treated with ADSCs and OA controls. Other results were analyzed regarding benefits provided by different ADSCs doses, the effects versus other injectable treatments, and the effects derived from the combination of ADSCs with other products. Risk of bias was assessed according to the SYRCLE’s tool.
Results
Seventy-two studies were included, for a total of 2,058 animals. The publication trend increased over the years (>50% of the articles published from 2018). ADSCs injections provided disease-modifying effects in 92.3% of studies (positive effects on cartilage and/or synovial membrane). In detail, 85.0% reported better macroscopic results, 90.2% better histological results, and 95% better immunohistochemical results, while the 86% reported positive changes in biomarker profile and 78% reported better clinical results compared to OA controls. Evidence was limited on the best ADSCs doses, injection schedule, and comparison with other injectables. A synergistic effect of the combined use with HA was suggested in 5 studies. Risk of bias was low in 38%, unclear in 51%, and high in 11% of items.
Conclusion
ADSCs injections showed disease-modifying effects in most studies. These findings in animal OA models can play a crucial role in understanding mechanisms of action of this biological approach, although high level clinical studies should demonstrate if these results translate into disease-modifying effects when ADSCs are used in the clinical practice to treat OA.