1.
Intra-articular injections of platelet-rich plasma decrease pain and improve functional outcomes than sham saline in patients with knee osteoarthritis
Chu J, Duan W, Yu Z, Tao T, Xu J, Ma Q, Zhao L, Guo JJ
Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA. 2022
Abstract
PURPOSE To compare the long-term clinical efficacy 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 (five 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% confidence interval 3.6-4.5) greater than that of whole blood. Both groups showed significant 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 significant differences between the P-PRP and sham saline groups in all clinical outcome measurements at each follow-up time point (P < 0.001). The benefit 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 significant differences between treatments were documented in terms of WOMAC-stiffness at any follow-up. A clinically significant difference 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 fluid 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 difference between the group was statistically significant (intergroup difference, 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 effective 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 profiles.
2.
No Benefit to Platelet-rich Plasma Over Placebo Injections in Terms of Pain or Function in Patients with Hemophilic Knee Arthritis: A Randomized Trial
Duan W, Su X, Yu Z, Jiang M, Zhao L, Giannoudis PV, Guo JJ
Clinical orthopaedics and related research. 2022
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Abstract
BACKGROUND Hemophilic knee arthritis is one of the most common presenting symptoms of hemophilia, and its management continues to be challenging to practitioners. Preliminary research has suggested that platelet-rich plasma (PRP) may have short-term efficacy in the treatment of hemophilic knee arthritis, but evidence for this treatment is limited. QUESTIONS/PURPOSES What is the effectiveness of PRP compared with placebo in (1) reducing pain and improving knee joint function (as measured by WOMAC, VAS, and Hemophilia Joint Health Score [HJHS]) and (2) improving quality of life (as measured by SF-36 scores) in patients with hemophilic knee arthritis through 24 months of follow-up? METHODS This was a prospective, parallel-group, double-blinded, single-center, placebo-controlled randomized clinical trial that included participants from a tertiary care center starting January 1, 2019, with follow-up completed on November 30, 2021. Participants were older than 18 years and had hemophilic knee arthritis confirmed by MRI, and they were randomly allocated to interventions in a 1:1 ratio. The investigators were not informed of the randomization sequence generated by the computer. Patient groups were comparable with respect to age, gender, BMI, hemophilia type, and disease severity at baseline. Physicians delivered three sessions (one per week) of a standard intraarticular injection of PRP (n = 95) or placebo (n = 95). The rate of successful blinding was balanced across the groups, which was assessed by asking participants which injection they thought they had received. The primary outcome was the WOMAC score (range 0 to 96; higher scores indicate more pain and worse function; minimum clinically important difference, 6.4 points) over 24 months. Among the 190 patients assigned to PRP or saline injections (mean age 31 ± 7 years), 100% (190) of patients were men). There was no between-group difference in the proportion of patients who completed the trial; 97% (92 of 95) of patients in the PRP group and 94% (89 of 95) of patients in the placebo group completed the trial. The most common adverse events were injection site discomfort 8% (8 of 95) in the PRP group and 4% (4 of 95) in the placebo group. An intention-to-treat analysis was planned, but there was no crossover between groups. All patients were included in the analyses. With 95 patients in each group, the study was powered a priori at 90% to detect a difference in WOMAC score of 6.4 points, which was considered a clinically important difference. RESULTS There were no clinically important differences in the mean WOMAC, VAS pain, HJHS, SF-36, and MRI scores between groups at any timepoint. Intraarticular PRP did not ameliorate function, symptoms, and quality of life in patients with hemophilic knee arthritis. At 24 months of follow-up, the mean difference between the PRP and placebo groups in the WOMAC score was -1 (95% CI -5 to 2; p = 0.42). The mean difference in the VAS pain score was -0.3 (95% CI -0.8 to 0.2; p = 0.19), in the HJHS was -0.6 (95% CI -1.4 to 0.1; p = 0.10), in the SF-36 physical component summary was 0 (95% CI -2 to 3; p = 0.87), and in the SF-36 mental component summary was -1 (95% CI -3 to 2; p = 0.64). The mean differences in the MRI scores of soft tissue and osteochondral subscore were 0.1 (95% CI -0.3 to 0.5; p = 0.59) and -0.3 (95% CI -0.7 to 0.1; p = 0.19), respectively. CONCLUSION Among patients with hemophilic knee arthritis, three intraarticular PRP injections, compared with placebo injections, did not improve hemophilic knee symptoms, function, and quality of life over 24 months. The results of this study do not support the use of PRP injections in patients who have hemophilic knee arthritis. LEVEL OF EVIDENCE Level I, therapeutic study.
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Platelet Rich Plasma Versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis: a Meta-Analysis of 26 randomized controlled trials
Tan J, Chen H, Zhao L, Huang W
Arthroscopy. 2020
Abstract
PURPOSE The aim of this study was to compare the effectiveness and safety of platelet-rich plasma (PRP) and hyaluronic acid (HA) in adult knee osteoarthritis (KOA) patients and to explore the most effective and safe protocol by using a meta-analysis method. METHODS This study was based on Cochrane methodology for conducting a meta-analysis. Only randomized controlled trials with an experimental group that used PRP and a control group that received HA were eligible for this study. The participants were adults who had KOA. The outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the visual analog scale (VAS), the EuroQol visual analog scale (EQ-VAS), the International Knee Documentation Committee (IKDC), the Tegner score, the Lequesne Scale, the Knee injury Osteoarthritis Outcome Score, satisfaction rate and adverse events. Subgroup analyses was performed for patients with different doses, types and times of PRP interventions and grades of OA. The Review Manager Database was used to analyze the included studies. RESULTS Twenty-six randomized controlled trials involving 2430 patients were included. The WOMAC total scores, WOMAC physical function scores and VAS scores of the PRP group were better than the those of the HA group at 3, 6 and 12 months. The PRP group had better WOMAC pain, WOMAC stiffness, EQ-VAS and IKDC scores than the HA group at 6 and 12 months. There was no significant difference in adverse events between the two groups (RR, 1.21 [95% CI, 0.95 to 1.54]; p = 0.13). CONCLUSIONS For the nonsurgical treatment of KOA, compared with HA, intra-articular injection of PRP could significantly reduce patients' early pain and improve function. There was no significant difference in adverse events between the two groups. PRP was more effective than HA in the treatment of KOA, and the safety of these two treatment options was comparable. LEVEL OF EVIDENCE Level I, meta-analysis of Level I RCTs.