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 Minimally anterolateral approach (MAA) and direct anterior approach (DAA) have been reported as beneficial for total hip arthroplasty (THA) due to their ability to reduce postoperative pain and lead to quicker rehabilitation by preserving muscle insertions. As there is an ongoing debate on the effect of these two approaches on early postoperative outcomes, this prospective study aimed to assess the difference in early clinical, radiological, and patient-reported outcomes between the two minimally invasive approaches. Methods A total of 98 patients, 50 in the MAA group and 48 in the DAA group, were included in the study. Patients with complete data were evaluated preoperatively and postoperatively at 2, 6, and 12 weeks. Clinical measurements, including the ability to climb stairs and walk, 6-min walk test (6MWT), the Forgotten Joint Scale (FJS-12), Japanese Orthopedic Association (JOA) Hip scores, radiological evaluation, and complications were analyzed. Results There were no significant differences in clinical outcomes and implant alignments between MAA and DAA groups. In regards to patient-reported outcomes, the FJS-12 was significantly higher in the MAA group compared to group DAA at 2 and 6 weeks postoperatively. However, there was no significant difference in the FJS-12 between the two groups 12 weeks after surgery. The differences also included shorter operative times (62.4 ± 9.05 min vs. 71 ± 8.01 min), less blood loss (132.6 ± 43.31 ml vs. 159.23 ± 37.25 ml), lower Hb drop (29.56 ± 8.02 g/L vs. 36.4 ± 7.12 g/L), and fewer blood transfusions in the MAA group (4.0% vs. 18.8%). The incidence of the lateral femoral cutaneous nerve (LFCN) neuropraxia after surgery was 7 (14.6%) in the DAA group and 0 in the MAA group. One fracture was found in each group and managed conservatively. Conclusion MAA and DAA approach yielded excellent and similar early clinical outcomes. However, better patient-reported outcomes could be achieved by MAA THA. The MAA resulted in a safer approach associated with shorter operative times, less blood loss, lower Hb drop, fewer blood transfusions, and LFCN neuropraxia than DAA. A longer follow-up is needed to further examine differences between these procedures.

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