Effect of Platelet-Rich Plasma Injection vs Sham Injection on Tendon Dysfunction in Patients With Chronic Midportion Achilles Tendinopathy: A Randomized Clinical Trial
IMPORTANCE Platelet-rich plasma injections are used as a treatment for chronic midportion Achilles tendinopathy, but evidence for this treatment is limited. OBJECTIVE In adults with midportion Achilles tendinopathy, to assess the effects of a single platelet-rich plasma injection, compared with sham injection, on the outcome of the Victorian Institute of Sport Assessment-Achilles (VISA-A) score (a single composite measure of Achilles tendinopathy severity). DESIGN, SETTING, AND PARTICIPANTS A participant-blinded, multicenter randomized clinical trial that included 240 people from 24 sites assigned to either a platelet-rich plasma injection or a sham injection between April 2016 and February 2020. Final follow-up was July 2020. Participants were older than 18 years with midportion Achilles tendon pain for more than 3 months as confirmed by ultrasound, magnetic resonance imaging, or both. INTERVENTIONS A single intratendinous platelet-rich plasma injection (n = 121) or a single sham injection (insertion of a subcutaneous dry needle not entering the tendon) (n = 119). MAIN OUTCOMES AND MEASURES The primary outcome was the VISA-A score, measured 6 months after treatment allocation. The VISA-A score contains 8 questions that cover 3 domains of pain, function, and activity, analyzed as a composite score (range, 0 [worst symptoms] to 100 [no symptoms]; minimal clinically important difference in score, 12 points). The primary analysis was adjusted for laterality, age, sex, and baseline VISA-A score. RESULTS Among 240 patients assigned to a platelet-rich plasma or sham injection (mean age, 52 years; 138 [58%] women), 221 (92%) completed the trial. At 6-month follow-up, mean VISA-A score values in the plasma-rich plasma group vs the sham injection group were 54.4 vs 53.4 (adjusted mean difference, -2.7 [95% CI, -8.8 to 3.3]). The most common adverse events compared between patients in the platelet-rich plasma group vs the sham group were injection site discomfort (97 vs 73 patients), swelling (56 vs 52 patients) and bruising (48 vs 49 patients). CONCLUSIONS AND RELEVANCE Among patients with chronic midportion Achilles tendinopathy, treatment with a single injection of intratendinous platelet-rich plasma, compared with insertion of a subcutaneous dry needle, did not reduce Achilles tendon dysfunction at 6 months. These findings do not support the use of this treatment for chronic midportion Achilles tendinopathy. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN13254422.
Platelet-rich plasma versus steroids injections for greater trochanter pain syndrome: a systematic review and meta-analysis
British medical bulletin. 2021
INTRODUCTION Greater trochanter pain syndrome (GTPS) is characterized by a persistent and debilitating pain around the greater trochanter. GTPS can be caused by a combination of gluteus medius or minimus tendinopathy, snapping hip or trochanteric bursitis. SOURCE OF DATA Recent published literatures identified from PubMed, EMBASE, Google Scholar, Scopus. AREAS OF AGREEMENT Platelet rich plasma (PRP) and corticosteroids (CCS) injections are useful options to manage symptoms of GTPS. AREAS OF CONTROVERSY Whether PRP leads to superior outcomes compared to CCS injections is unclear. GROWING POINTS A systematic review and meta-analysis comparing PRP versus CCS in the management of GTPS was conducted. AREAS TIMELY FOR DEVELOPING RESEARCH PRP injections are more effective than CCS at approximately 2 years follow-up.
Effect of Autologous Expanded Bone Marrow Mesenchymal Stem Cells or Leukocyte-Poor Platelet-Rich Plasma in Chronic Patellar Tendinopathy (With Gap >3 mm): Preliminary Outcomes After 6 Months of a Double-Blind, Randomized, Prospective Study
The American journal of sports medicine. 2021;:363546521998725
BACKGROUND Patellar tendinopathy is common. The success of traditional management, including isometric or eccentric exercises combined with shockwave therapy and even surgery, is limited. Therefore, it is important to determine whether biological treatments such as ultrasound-guided intratendinous and peritendinous injections of autologous expanded bone marrow mesenchymal stem cells (BM-MSCs) or leukocyte-poor platelet-rich plasma (Lp-PRP) improve clinical outcomes in athletic patients with patellar tendinopathy. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS A prospective, double-blinded, randomized, 2-arm parallel group, active controlled, phase 1/2 single-center clinical study was performed in patients who had proximal patellar tendinopathy with a lesion >3 mm. A total of 20 participants (age 18-48 years) with pain for >4 months (mean, 23.6 months) and unresponsive to nonoperative treatments were randomized into 2 groups. Of these, 10 participants were treated with BM-MSC (20 × 10(6) cells) and 10 with Lp-PRP. Both groups performed the same postintervention rehabilitation protocol. Outcomes included the Victorian Institute of Sport Assessment for pain (VISA-P), self-reported tendon pain during activity (visual analog scale [VAS]), muscle function by dynamometry, tendon thickness and intratendinous vascularity by ultrasonographic imaging and Doppler signal, ultrasound tissue characterization (UTC) echo type changes, and magnetic resonance imaging (MRI) T2-weighted mapping changes. Participants were followed longitudinally for 6 months. RESULTS The average VAS scores improved in both groups at all time points, and there was a significant reduction in pain during sporting activities (P < .05). In both groups, the average mean VISA-P scores at 6 months were significantly increased compared with baseline (66 BM-MSC group and 72.90 Lp-PRP group), with no significant differences in VAS or VISA-P scores between the groups. There were statistically significant greater improvements in tendon structure on 2-dimensional ultrasound and UTC in the BM-MSC group compared with the Lp-PRP group at 6 months. Similarly, the BM-MSC group demonstrated significant evidence of restoration of tendon structure on MRI compared with the Lp-PRP group at 6 months. Only the participants in the BM-MSC group showed evidence of normalization of tendon structure, with statistically significant differences between the groups on T2-weighted, fat-saturated sagittal and coronal scans and hypersignal in T2-weighted on spin-echo T2-weighted coronal MRI scan. Both treatments were safe, and no significant adverse events were reported in either group. CONCLUSION Treatment with BM-MSC or Lp-PRP in combination with rehabilitation in chronic patellar tendinopathy is effective in reducing pain and improving activity levels in active participants. Participants who received BM-MSC treatment demonstrated greater improvement in tendon structure compared with those who received Lp-PRP. REGISTRATION 2016-001262-28 (EudraCT identifier); NCT03454737 (ClinicalTrials.gov identifier).
Treatment of medication-related osteonecrosis of the jaw (MRONJ). A systematic review
European review for medical and pharmacological sciences. 2021;25(6):2662-2673
OBJECTIVE Medication-related osteonecrosis of the jaw (MRONJ) is a severe drug-related side effect mostly seen in the maxillofacial region of patients under current or previous treatment with antiresorptive and/or angiogenic agents. There is a wide range of treatment options explained in literature for the management of this condition, from conservative treatments to surgical procedures of various levels of invasiveness, which are sometimes supplemented with adjunctive therapies. The present systematic review aimed at evaluating the treatment options of MRONJ in terms of successful outcomes. MATERIALS AND METHODS Medline, Scopus, and Cochrane databases were searched. The search was limited to clinical studies involving human subjects with at least 3 cases. There was no other limitation for language, publication date, and study design for the articles to be included. A hand search of the bibliographies of identified articles was also performed. The evaluation criterion was an improvement in the healing of the treated site after treatment procedures. RESULTS After evaluation of the full text of the articles, 118 articles were selected for evaluation (15 platelet concentrates, 4 teriparatide, 10 laser therapy, 3 hyperbaric oxygen, 2 ozone applications, 9 conservative protocols, and 75 surgical interventions articles). The evaluated articles reported positive improvements in healing/staging of the osteonecrosis sites. CONCLUSIONS Due to the low evidence level and the limited sample size of the studies included, the results of this review must be cautiously interpreted. However, they can be suggestive for evaluating the possible benefits of these treatment options in MRONJ management. Further prospective comparative studies with a large sample size are urgently needed to confirm the results.
Comparison of a Platelet-Rich Plasma Injection and a Conventional Steroid Injection for Pain Relief and Functional Improvement of Partial Supraspinatus Tears
Orthopaedic journal of sports medicine. 2021;9(9):23259671211024937
BACKGROUND Partial supraspinatus tendon tears have frequently been treated using a subacromial corticosteroid injection or surgery. The clinical use of a platelet-rich plasma (PRP) injection is an alternative treatment method for the condition, despite the paucity of evidence of its efficacy. PURPOSE To compare pain relief, functional improvement, and complications after an intratendinous PRP injection versus a subacromial corticosteroid injection for partial supraspinatus tears. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS A total of 32 patients with partial supraspinatus tears were randomly assigned to receive a leukocyte-poor PRP (LP-PRP) injection or a corticosteroid injection. One patient withdrew from the PRP group, leaving 15 patients in the PRP group and 16 patients in the corticosteroid group. The ultrasound-guided procedures were performed by a single experienced pain physician. Pain relief and functional improvement were evaluated using the visual analog scale (VAS) and the Oxford Shoulder Score (OSS), respectively. Treatment efficacy and complications were documented, and the 2 groups were compared at 1- and 6-month follow-up. RESULTS There were no differences in VAS and OSS scores between the PRP and corticosteroid groups at 1-month follow-up. However, the PRP group had better scores than the corticosteroid group had on both the VAS and OSS at 6-month follow-up (VAS: 14.5 ± 15.4 vs 37.5 ± 24.9, respectively; OSS: 16.2 ± 3.9 vs 25.0 ± 10.2, respectively; P < .01 for both). Both groups showed significant improvement in VAS and OSS scores from before treatment to 1-month follow-up (mean difference, 35.67 and 11.47 points, respectively, for the PRP group; mean difference, 29.69 and 11.13 points, respectively, for the corticosteroid group; P < .01 for all). The VAS and OSS scores did not change significantly at 6-month follow-up in the corticosteroid group; however, the PRP group showed continued improvement in both VAS and OSS scores between 1- and 6-month follow-up (mean difference, 15.87 and 7.40 points, respectively; P < .01 for both). There were no complications in either group. CONCLUSION An injection using either a corticosteroid or LP-PRP resulted in a similar reduction in pain and improvement in function at 1 month in patients with a partial supraspinatus tear. However, PRP showed superior benefits over the corticosteroid at 6-month follow-up.
Effect of Platelet-Rich Plasma Injections vs Placebo on Ankle Symptoms and Function in Patients With Ankle Osteoarthritis: A Randomized Clinical Trial
IMPORTANCE Approximately 3.4% of adults have ankle (tibiotalar) osteoarthritis and, among younger patients, ankle osteoarthritis is more common than knee and hip osteoarthritis. Few effective nonsurgical interventions exist, but platelet-rich plasma (PRP) injections are widely used, with some evidence of efficacy in knee osteoarthritis. OBJECTIVE To determine the effect of PRP injections on symptoms and function in patients with ankle osteoarthritis. DESIGN, SETTING, AND PARTICIPANTS A multicenter, block-randomized, double-blinded, placebo-controlled clinical trial performed at 6 sites in the Netherlands that included 100 patients with pain greater than 40 on a visual analog scale (range, 0-100) and tibiotalar joint space narrowing. Enrollment began on August 24, 2018, and follow-up was completed on December 3, 2020. INTERVENTIONS Patients were randomly assigned (1:1) to receive 2 ultrasonography-guided intra-articular injections of either PRP (n = 48) or placebo (saline; n = 52). MAIN OUTCOMES AND MEASURES The primary outcome was the validated American Orthopaedic Foot and Ankle Society score (range, 0-100; higher scores indicate less pain and better function; minimal clinically important difference, 12 points) over 26 weeks. RESULTS Among 100 randomized patients (mean age, 56 years; 45 [45%] women), no patients were lost to follow-up for the primary outcome. Compared with baseline values, the mean American Orthopaedic Foot and Ankle Society score improved by 10 points in the PRP group (from 63 to 73 points [95% CI, 6-14]; P < .001) and 11 points in the placebo group (from 64 to 75 points [95% CI, 7-15]; P < .001). The adjusted between-group difference over 26 weeks was -1 ([95% CI, -6 to 3]; P = .56). One serious adverse event was reported in the placebo group, which was unrelated to the intervention; there were 13 other adverse events in the PRP group and 8 in the placebo group. CONCLUSIONS AND RELEVANCE Among patients with ankle osteoarthritis, intra-articular PRP injections, compared with placebo injections, did not significantly improve ankle symptoms and function over 26 weeks. The results of this study do not support the use of PRP injections for ankle osteoarthritis. TRIAL REGISTRATION Netherlands Trial Register: NTR7261.
Comparing Intra-articular Injections of Leukocyte-Poor Platelet-Rich Plasma Versus Low-Molecular Weight Hyaluronic Acid for the Treatment of Symptomatic Osteoarthritis of the Hip: A Double-Blind, Randomized Pilot Study
Orthopaedic journal of sports medicine. 2021;9(1):2325967120969210
BACKGROUND Hyaluronic acid (HA) and leukocyte-poor platelet-rich plasma (LP-PRP) are 2 nonoperative treatment options that have been studied in patients with hip osteoarthritis (OA). PURPOSE To compare the efficacy of intra-articular injections of low-molecular weight (LMW) HA and LP-PRP in patients with hip OA. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS A total of 34 patients (36 hips) presenting with signs of hip OA were randomized to receive 3 blinded, weekly intra-articular injections of either LP-PRP or LMW-HA. Patients were prospectively evaluated before injections and at 6 weeks and then at 3, 6, 12, and 24 months. The primary outcome, conversion to total hip arthroplasty (THA) or a hip resurfacing procedure, was analyzed along with secondary outcomes including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and hip range of motion. RESULTS The final analysis included 33 hips (mean Kellgren-Lawrence grade, 2.73) (LMW-HA: n = 14; LP-PRP: n = 19) in 31 patients (18 male; mean age, 53.8 years). Significantly more patients converted to THA or a hip resurfacing procedure in the LMW-HA group (7/14; 50.0%) (mean, 1.3 years after first injection) than the LP-PRP group (3/19; 15.8%) (mean, 0.73 years after first injection) (P = .035). There was no significant improvement or decline in any outcome scores within the LMW-HA group from before injections to 6 weeks or 3, 6, and 12 months. For the LP-PRP group, WOMAC overall (P = .032), joint (P = .030), and function scores (P = .025) significantly improved from before injections to 6 weeks, and WOMAC joint scores significantly improved from before injections to 6 months (P = .036). When comparing the difference between groups in internal rotation at 90° of hip flexion from before injections to 6 months, the LP-PRP group demonstrated a mean 5.0° improvement, while the LMW-HA group showed a mean 1.5° decrease (P = .028). CONCLUSION Intra-articular hip injections of LP-PRP in patients with hip OA resulted in an improvement in WOMAC scores and hip internal rotation at 6 months and delayed the need for THA or a hip resurfacing procedure compared with treatment with LMW-HA. A longer follow-up is necessary to further compare the effects of LP-PRP and LMW-HA injections in patients with hip OA. REGISTRATION NCT01920152 (ClinicalTrials.gov identifier).
Intra Articular Injection Of Autologous Microfat And Platelet-Rich Plasma In The Treatment Of Knee Osteoarthritis: A Double Blind Randomized Comparative Study
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 2021
PURPOSE Compare a single abdominal microfat (MF) injection mixed or not with PRP Low Dose (LD) or High Dose (HD) in order to improve MRI parameters and alleviate pain and enhance functional capacity in knee osteoarthritis (OA). METHODS Patients with symptomatic grade 2 to 4 knee OA according to the International Cartilage Repair Society MRI classification were selected. They were prospectively assessed at baseline, at 3 and 6 months of follow-up. The primary endpoint was the change in maximum of value of cartilage relaxation time in T2 mapping sequences (T2max) at 3 months. Secondary endpoints were MRI grade severity and joint space assessment, WOMAC score, pain evaluation, knee range of motion and patient's satisfaction. Adverse events were also collected. The complete cell counts and growth factors content of injected products were assessed to analyze their potential relationship with MRI/clinical outcomes. RESULTS Three groups of 10 patients received a single injection of 10 cc of a mix (1:1) containing either MF-Saline, MF-PRP LD or MF-PRP HD. T2max did not change significantly over the time for any of the groups. All treatments significantly improved knee functional status and symptoms relief at 3 and 6 months. All patients were responders in the MF/PRP HD at 3 months and significantly higher compared to MF/PRP LD. Half of the injected PRP in the MF/PRP LD group displayed RBCs contamination over 8% which was correlated with an impairment of T2max. CONCLUSION A single intra articular injection of MF with or without PRP is safe and may offer a significant clinical improvement in patients with OA.
Clinical and Microbiological Outcomes Associated With Use of Platelet-Rich Plasma in Chronic Venous Leg Uclers: A Randomized Controlled Trial
Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society. 2021;48(4):292-299
PURPOSE To evaluate the susceptibility profiles of Staphylococcus aureus and Pseudomonas aeruginosa strains identified in chronic venous ulcers treated with platelet-rich plasma (PRP) and petrolatum gauze or petrolatum gauze alone and to quantitatively evaluate the bacterial load and biofilm-forming capacities of the detected S. aureus and P. aeruginosa strains. DESIGN Randomized controlled trial. SUBJECTS AND SETTING The convenience sample included 36 participants; 18 were allocated to the PRP combined with the petrolatum gauze group, and 18 were allocated to the control group, which was treated with petrolatum gauze alone. METHODS Thirty-six patients presenting with chronic venous ulcers were consecutively randomized to the PRP group (n = 18) or the petrolatum gauze control group (n = 18). We followed participants for 3 months during treatment and collected swab cultures from their wounds during weeks 1, 6, and 12 or until the wounds healed. The samples were analyzed using mass spectrometry. Antimicrobial susceptibility tests were performed using disk diffusion. RESULTS P. aeruginosa was identified in 39 (39%) of 100 samples, and S. aureus was detected in only 10 (10%) samples collected over the study period. At the end of the 12-week treatment period, the wound infections reduced in both the PRP (P = .0078) and control groups (P = .01). The microorganisms were susceptible to most of the tested antimicrobials. The PRP did not increase the bacterial load in the wounds. All S. aureus strains identified showed biofilm-forming capacities and were classified as weak biofilm producers. All P. aeruginosa strains produced biofilm, with 17 strains being classified as weak, 14 as moderate, and 8 as strong biofilm producers. CONCLUSIONS The PRP plus petrolatum gauze did not increase bacteriological growth or the microbial load in chronic venous ulcers compared with petrolatum gauze alone and could be a considered as an advanced treatment option for these types of chronic wounds.
A Prospective Randomized Double-Blind Clinical Trial to Assess the Effects of Leukocyte-reduced Platelet-Rich Plasma on Pro-inflammatory, Degradative, and Anabolic Biomarkers after Closed Pilon Fractures
Journal of orthopaedic research : official publication of the Orthopaedic Research Society. 2021
Post-traumatic osteoarthritis (PTOA) significantly affects patients with pilon fractures even after adequate anatomical reduction, and treatment strategies targeting the biologic mediators of PTOA are needed. This study was designed to determine the effects of intra-articular injection of platelet-rich plasma (PRP) on synovial fluid (SF) biomarkers for patients undergoing open reduction and internal fixation (ORIF) of pilon fractures. Patients undergoing staged management of pilon fractures were enrolled in a prospective, double-blinded, randomized, placebo-controlled clinical trial to determine the effects of a single intra-articular injection of leukocyte-reduced PRP on SF biomarkers. Arthrocentesis of the injured and uninjured ankles was performed at time of external skeletal fixation (ESF) and ORIF. Patients were randomized to receive either autogenous leukocyte-reduced PRP or saline (control) via intra-articular injection into the injured ankle at time of ESF. SF biomarker concentrations were compared--uninjured, injured pre-treatment, and saline-injected or PRP-injected. Eleven patients (PRP, n=5; saline, n=6) completed the study. 21 un-injured, and 11 injured pre-treatment, 5 PRP-treated, and 6 saline-treated SF samples were analyzed. PRP-treated SF contained significantly higher levels of PDGF-AA (p=0.046) and significantly lower levels of MMP-3 (p=0.042), MMP-9 (p=0.009), IL-1β (p=0.049), IL-6 (p<0.01), IL-8 (p=0.048) and PGE2 (p<0.04). This study provided mechanistic data to suggest that a single intraarticular injection of leukocyte-reduced PRP is associated with anti-inflammatory, anti-degradative and anabolic responses compared to saline control. These findings provide the impetus for investigating long-term clinical outcomes after PRP injection as an orthobiologic adjunct to ORIF for mitigating the incidence and severity of PTOA after pilon fractures. This article is protected by copyright. All rights reserved.