Purpose To compare the long-term clinical eicacy provided by intra-articular injections of either Pure Platelet-rich Plasma (P-PRP) or sham saline to treat knee osteoarthritis (KOA). Methods This prospective, parallel-group, double-blind, multi-center, sham-controlled randomized clinical trial recruited participants with KOA from orthopedic departments at nine public hospitals (ive tertiary medical centers, four secondary medical units) starting January 1, 2014, with follow-up completed on February 28, 2021. Participants were randomly allocated to interventions in a 1:1 ratio. Data were analyzed from March 1, 2021, to July 15, 2021. Three sessions (1 every week) of P-PRP or sham saline injected by physicians. The primary outcome was the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 6, 12, 24, 60 months of follow-up. Secondary outcomes included the International Knee Documentation Committee (IKDC) subjective score, visual analogue scale (VAS) score, intra-articular biochemical marker concentrations, cartilage volume, and adverse events. Laboratory of each hospital analyzed the content and quality of P-PRP. Results 610 participants (59% women) with KOA who received three sessions of P-PRP (n = 308, mean age 53.91 years) or sham saline (n = 302, mean age 54.51 years) injections completed the trial. The mean platelet concentration in PRP is 4.3 fold (95% conidence interval 3.6-4.5) greater than that of whole blood. Both groups showed signiicant improvements in IKDC, WOMAC, and VAS scores at 1 month of follow-up. However, only the P-PRP group showed a sustained improvement in clinical outcome measurements at month 24 (P < 0.001). There were statistically signiicant diferences between the P-PRP and sham saline groups in all clinical outcome measurements at each follow-up time point (P < 0.001). The beneit of P-PRP was clinically better in terms of WOMAC-pain, WOMAC-physical function and WOMAC-total at 6, 12, 24, and 60 months of follow-up. No clinically signiicant diferences between treatments were documented in terms of WOMAC-stifness at any follow-up. A clinically signiicant diference favoring P-PRP group against saline in terms of IKDC and VAS scores was documented at 6, 12, 24 and 60 months of follow-up. At 6 months after injection, TNF-α and IL-1β levels in synovial luid were lower in the P-PRP group (P < 0.001). Tibiofemoral cartilage volume decreased by a mean value of 1171 mm 3 in the P-PRP group and 2311 mm 3 in the saline group over 60 months and the diference between the group was statistically signiicant (intergroup diference, 1140 mm 3 , 95% CI − 79 to 1320 mm 3 ; P < 0.001). Conclusions In this randomized clinical trial of patients with KOA, P-PRP was superior to sham saline in treating KOA. P-PRP was efective for achieving at least 24 months of symptom relief and slowing the progress of KOA, with both P-PRP and saline being comparable in safety proiles.
Background: Bilateral arthroscopic rotator cuff repair (ARCR) is frequently performed in patients with symptomatic bilateral rotator cuff tears. Purpose: To compare patient-reported outcomes and mobility between simultaneous and staged bilateral ARCR. Study Design: Cohort study; Level of evidence, 3. Methods: Included were 51 patients who underwent simultaneous (anesthetized once) and 42 patients who underwent staged (anesthetized twice) bilateral ARCR between January 2014 and January 2018; for the staged group, the interval between procedures was at least 12 months. All operations were performed by the same surgeon, and all patients had minimum 24-month follow up in both shoulders. Patient-reported outcomes and range of motion (ROM) were assessed preoperatively and postoperatively and compared between groups. Outcome measures included the Constant-Murley score (CMS) and American Shoulder and Elbow Surgeons (ASES) score as well as measures of psychological status, health-related quality of life, activities of daily living (ADL), and patient satisfaction with the state of one’s shoulders. Results: The mean follow-up times for the staged and simultaneous ARCR groups were 44.1 months (range, 36-60 months) and 37.5 months (range, 25-59 months), respectively. There were no significant differences in age, tear size, or fatty degeneration of rotator cuff muscles between the groups. The cumulative length of hospital stay in the staged group was significantly longer than in the simultaneous group ( P < .001). At the final follow-up, both groups showed significant improvement in ROM, CMS, and ASES scores ( P < .05). No significant differences between the groups were observed in terms of ROM, CMS, and ASES scores postoperatively. At 24 months postoperatively, psychological status and health-related quality of life in both groups improved significantly ( P < .05), and there were no significant between-group differences. Patients were able to perform most essential ADL. Both groups had high patient satisfaction, but patient satisfaction for the second shoulder of the staged group was lower than that of the simultaneous group ( P = .039). Conclusion: Simultaneous bilateral ARCR was shown to be effective, resulting in similar improvements in clinical outcomes to staged bilateral ARCR at 2-year follow-up. In addition to higher patient satisfaction, simultaneous bilateral ARCR also had a shorter treatment cycle.
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