Efficacy of Intra-articular Injection of a Newly Developed Plasma Rich in Growth Factor (PRGF) Versus Hyaluronic Acid on Pain and Function of Patients with Knee Osteoarthritis: A Single-Blinded Randomized Clinical Trial

Raeissadat, Seyed Ahmad; Rayegani, Seyed Mansoor; Ahangar, Azadeh Gharooee; Abadi, Porya Hassan; Mojgani, Parviz; Ahangar, Omid Gharooi

doi:10.1177/1179544117733452

Cited by 54 publications

(77 citation statements)

References 43 publications

(67 reference statements)

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“…However, our results discovered that the perm-test could produce the highest power among the three non-parametric methods. A power of 80% is usually expected from statistical tests [11]. However, using the perm-test for analysis of small sample size could not achieve this level even using the largest sample size (n=30).…”

Section: Discussionmentioning

confidence: 97%

“…The t-test and the M-W test are commonly used to examine the clinical differences in efficacy between two treatments for knee OA [10,11]. To our best knowledge, the two non-parametric tests (the perm-test and the K-S test) have not been applied to test these clinical differences.…”

Section: Discussionmentioning

confidence: 99%

“…These parameters were collected from a randomized, controlled, single-blind study (IRCT2016071513442N11). [11] Two patient groups were treated with plasma rich in growth factor and hyaluronic acid injections respectively, and WOMAC score changes between baseline and six months follow-up were measured (Table 2).…”

Section: Self-report Indexmentioning

confidence: 99%

“…The data were generated from a normal distribution of the parameters that had means and standard deviations collected from the previous studies (Tables 1 and 2). [10,11] The generated data between two treatments for each replicate were tested by the t-test, the M-W test, the K-S test, and the perm-test respectively. The percentage of 10,000 replicates that had a significant difference (p-value < 0.05) was defined as statistical power for p1-p4 and a false positive rate for p5-p8.…”

Section: Simulation Proceduresmentioning

confidence: 99%

“…WOMAC index changes in patients treated for knee OA between baseline and 6 months follow-up collected from the literature[11].HA: hyaluronic acid; PRGF: plasma rich in growth factor; CV: coefficient of variation.NA: not available. $: effect size calculated based on equal sample sizes.…”

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confidence: 99%

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Comparison of statistical methods for analysis of small sample sizes for detecting the differences in efficacy between treatments for knee osteoarthritis

Shih¹,

Hung

2020

Preprint

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Background A small sample size (n < 30 for each treatment group) is usually enrolled to investigate the differences in efficacy between treatments for knee osteoarthritis (OA). The objective of this study was to use simulation for comparing the power of four statistical methods for analysis of small sample size for detecting the differences in efficacy between two treatments for knee OA. Methods A total of 10,000 replicates of 5 sample sizes (n=10, 15, 20, 25, and 30 for each group) were generated based on the previous reported measures of treatment efficacy. Four statistical methods were used to compare the differences in efficacy between treatments, including the two-sample t-test (t-test), the Mann-Whitney U-test (M-W test), the Kolmogorov-Smirnov test (K-S test), and the permutation test (perm-test). Results The bias of simulated parameter means showed a decreased trend with sample size but the CV% of simulated parameter means varied with sample sizes for all parameters. For the largest sample size (n=30), the CV% could achieve a small level (<20%) for almost all parameters but the bias could not. Among the non-parametric tests for analysis of small sample size, the perm-test had the highest statistical power, and its false positive rate was not affected by sample size. However, the power of the perm-test could not achieve a high value (80%) even using the largest sample size (n=30). Conclusion The perm-test is suggested for analysis of small sample size to compare the differences in efficacy between two treatments for knee OA.

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Section: Self-report Indexmentioning

confidence: 99%

Section: Simulation Proceduresmentioning

confidence: 99%

mentioning

confidence: 99%

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Comparison of statistical methods for analysis of small sample sizes for detecting the differences in efficacy between treatments for knee osteoarthritis

Shih¹,

Hung

2020

Preprint

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Platelet‐rich plasma intra‐articular knee injections from open preparation techniques do not pose a higher risk of joint infection: A systematic review of 91 randomized controlled trials and 5914 injections

Alazzeh,

Naseh,

Vasiliadis

et al. 2024

J. exp. orthop.

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PurposeTo compare the infection rate of intraarticular platelet‐rich plasma (PRP) knee injections between open and closed techniques in randomized controlled trials (RCTs) published in the last decade.MethodsFollowing the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines, PubMed, Scopus and Virtual Health Library were accessed in October 2022 using the terms ‘platelet‐rich plasma’, ‘PRP’, ‘knee’ and ‘tibiofemoral’ alone and in combination with Boolean operators AND/OR. RCTs published during the last 10 years evaluating PRP intra‐articular knee injections were considered eligible. Studies were excluded if the kit/preparation technique was not described. Data were presented using individual studies' absolute values, totals, and pooled percentages. Publication bias was assessed using the ROBIS tool.ResultsNinety‐one studies met the predetermined eligibility criteria. Forty‐one implemented a closed technique, while 50 were open. All studies implementing a closed technique disclosed their commercial kits. Only 16 studies (17.58%) failed to report joint infections. Among the studies reporting joint infections as outcomes, 30 implemented a closed technique with 1195 patients, 1921 intra‐articular knee injections and 95.44% of patient follow‐up. On the other hand, 45 of them implemented an open technique with 2290 patients, 3993 intra‐articular knee injections and 97.07% of patient follow‐up. No patient had a joint infection among the included studies. Thirty‐three studies prepared their PRP in controlled environments (36.26%). Most studies did not report where the preparation occurred (48.35%). Only twelve studies disclosed using laminar flow during preparation (13.19%). The infection rate for both techniques was 0 per 1000 knee injections.ConclusionOpen PRP preparation techniques do not pose a higher risk of joint infection and can lower manufacturing costs when appropriate facilities are available. However, PRP preparation setting and laminar flow implementation data are deficient, and minimal requirements for good manufacturing practices demand further studies while adhering to local and regional regulations.Level of EvidenceLevel I, systematic review of RCTs.

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Intra-articular injections of platelet-rich plasma in symptomatic knee osteoarthritis: a consensus statement from French-speaking experts

Eymard

Ornetti

Maillet

et al. 2020

Knee Surg Sports Traumatol Arthrosc

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Purpose There has been much debate regarding the use of intra-articular injections of platelet-rich plasma (PRP) as symptomatic treatment for knee osteoarthritis. The objective of this consensus was to develop guidelines for PRP injections in knee osteoarthritis according to the French National Authority for Health recommendations. Methods Fifteen physicians from different French-speaking countries (10 rheumatologists, 4 specialists in rehabilitation and sports medicine and 1 radiologist) were selected for their expertise in the areas of PRP and osteoarthritis. A comprehensive literature review was conducted on Medline including all published therapeutic trials, open studies, meta-analysis and systematic reviews focusing on the effects of PRP in knee OA, as well as fundamental studies concerning the characteristics of the various types of PRP and their mechanisms, indexed before April 2019. Using the method recommended by the French National Authority for Health inspired by the Delphi consensus process, 25 recommendations were finally retained and evaluated. The recommendations were classified as appropriate or not appropriate, with strong or relative agreement, or uncertain if a consensus was not achieved. Results Among the 25 recommendations selected, the main ones are the following: (1) Intra-articular injections of PRP are an effective symptomatic treatment for early to moderate knee osteoarthritis. This recommendation was considered appropriate with a relative agreement (Median = 8; rank = 6–9). Level of evidence 1A. (2) A PRP treatment sequence in knee osteoarthritis may include 1–3 injections. This recommendation was considered appropriate with a strong agreement (Median = 9; rank = 7–9). Level of evidence 1A. (3) Leucocytes-poor PRP should be preferred in knee osteoarthritis. This recommendation was considered appropriate with a relative agreement (Median = 8; rank = 5–9). Level of evidence 5. (4) Intra-articular PRP knee injections should be performed under ultrasound or fluoroscopic guidance. This recommendation was considered uncertain with no consensus (Median = 8; rank = 3–9). Level of evidence 5. (5) PRP should not be mixed with an anesthetic or intra-articular corticosteroid. This recommendation was considered appropriate with a relative agreement (Median = 9; rank = 6–9). Level of evidence 5 Conclusion Those 25 recommendations should standardize and facilitate the use of IA PRP injections, which are considered by experts as an effective treatment especially in early or moderate knee OA. Although a strong or relative agreement from the experts was obtained for most of the recommendations, many of them had a very low level of evidence (Level 5) and were principally based on the clinical experience of the experts.

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Efficacy of Intra-articular Injection of a Newly Developed Plasma Rich in Growth Factor (PRGF) Versus Hyaluronic Acid on Pain and Function of Patients with Knee Osteoarthritis: A Single-Blinded Randomized Clinical Trial

Cited by 54 publications

References 43 publications

Comparison of statistical methods for analysis of small sample sizes for detecting the differences in efficacy between treatments for knee osteoarthritis

Comparison of statistical methods for analysis of small sample sizes for detecting the differences in efficacy between treatments for knee osteoarthritis

Platelet‐rich plasma intra‐articular knee injections from open preparation techniques do not pose a higher risk of joint infection: A systematic review of 91 randomized controlled trials and 5914 injections

Intra-articular injections of platelet-rich plasma in symptomatic knee osteoarthritis: a consensus statement from French-speaking experts

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