Primary studies included in this systematic review

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Primary study

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Authors Jang SJ , Kim JD , Cha SS
Journal European journal of orthopaedic surgery & traumatology : orthopédie traumatologie
Year 2013
The aims of this study were to analyze the range of cartilage damage and patellofemoral joint (PFJ) degeneration in degenerative osteoarthritis (OA) and determine the duration for the positive effects of platelet-rich plasma (PRP) injection. This study included 65 patients suffering from OA that were treated with intra-articular PRP injection. The patients were prospectively evaluated at 1, 3, 6, 9, and 12 months after the procedure using a visual analogue scale (VAS) score and an International Knee Documentation Committee (IKDC) score. Clinical improvement in the average VAS score from 7.4 before the procedure to 4.2 at 6 months post-procedure had been reported, but the symptoms tended to deteriorate to 5.0 1 year after injection. The IKDC score also showed statistical significance (P < 0.05). Patients reported relapsed pain 8.8 months after the procedure. Developing degeneration according to the Kellgren-Lawrence grade reduced the clinical effects of PRP (P < 0.05) and also accelerated the time for feeling relapsed pain (P < 0.05). There was a statistically significant negative correlation between patient age and the PRP potential in the VAS score (slope = 0.1667) and IKDC score (slope = 1.3333). The presence of PFJ degeneration is expected to produce a worse outcome (P < 0.05). While intra-articular PRP injection can be used for the treatment of early OA, increasing age, and developing degeneration result in a decreased potential for PRP injection therapy.

Primary study

Unclassified

Journal The American journal of sports medicine
Year 2013
ABSTRACT: BACKGROUND: Specific growth factors have been proposed as therapeutic proteins for cartilage repair. HYPOTHESIS: Platelet-rich plasma (PRP) provides symptomatic relief in early osteoarthritis (OA) of the knee. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 78 patients (156 knees) with bilateral OA were divided randomly into 3 groups. Group A (52 knees) received a single injection of PRP, group B (50 knees) received 2 injections of PRP 3 weeks apart, and group C (46 knees) received a single injection of normal saline. White blood cell (WBC)-filtered PRP with a platelet count 3 times that of baseline (PRP type 4B) was administered in all. All the groups were homogeneous and comparable in baseline characteristics. Clinical outcome was evaluated using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire before treatment and at 6 weeks, 3 months, and 6 months after treatment. They were also evaluated for pain by a visual analog scale, and overall satisfaction with the procedure and complications were noted. RESULTS: Statistically significant improvement in all WOMAC parameters was noted in groups A and B within 2 to 3 weeks and lasting until the final follow-up at 6 months, with slight worsening at the 6-month follow-up. The mean WOMAC scores (pain, stiffness, physical function, and total score) for group A at baseline were 10.18, 3.12, 36.56, and 49.86, respectively, and at final follow-up were 5.00, 2.10, 20.08, and 27.18, respectively, showing significant improvement. Similar improvement was noted in group B (mean WOMAC scores at baseline: 10.62, 3.50, 39.10, and 53.20, respectively; mean WOMAC scores at final follow-up: 6.18, 1.88, 22.40, and 30.48, respectively). In group C, the mean WOMAC scores deteriorated from baseline (9.04, 2.70, 33.80, and 45.54, respectively) to final follow-up (10.87, 2.76, 39.46, and 53.09, respectively). The 3 groups were compared with each other, and no improvement was noted in group C as compared with groups A and B (P < .001). There was no difference between groups A and B, and there was no influence of age, sex, weight, or body mass index on the outcome. Knees with Ahlback grade 1 fared better than those with grade 2. Mild complications such as nausea and dizziness, which were of short duration, were observed in 6 patients (22.2%) in group A and 11 patients (44%) in group B. CONCLUSION: A single dose of WBC-filtered PRP in concentrations of 10 times the normal amount is as effective as 2 injections to alleviate symptoms in early knee OA. The results, however, deteriorate after 6 months. Both groups treated with PRP had better results than did the group injected with saline only.

Primary study

Unclassified

Journal Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine
Year 2013
The purpose of this study was to investigate whether platelet-rich plasma therapy for early knee osteoarthritis is associated with good clinical outcomes and a change in magnetic resonance imaging (MRI) structural appearances. The design was a prospective cohort study following patients 1 year after platelet-rich plasma therapy for knee osteoarthritis. Twenty-two patients were treated with platelet-rich plasma for early osteoarthritis, confirmed with a baseline MRI. Inclusion criteria were Kellgren grade 0-II with knee pain in patients aged 30 to 70 years. All the patients received a 6-mL platelet-rich plasma injection using the Cascade system. Fifteen subjects underwent clinical assessments at baseline, 1 week, and 1, 3, 6, and 12 months, and MRIs at 1 year. Pain scores significantly decreased, whereas functional and clinical scores increased at 6 months and 1 year from baseline. Qualitative MRIs demonstrated no change per compartment in at least 73% of cases at 1 year.

Primary study

Unclassified

Journal Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association
Year 2012
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<b>PURPOSE: </b>This multicenter, double-blind clinical trial evaluated and compared the efficacy and safety of PRGF-Endoret (BTI Biotechnology Institute, Vitoria-Gasteiz, Spain), an autologous biological therapy for regenerative purposes, versus hyaluronic acid (HA) as a short-term treatment for knee pain from osteoarthritis.<b>METHODS: </b>We randomly assigned 176 patients with symptomatic knee osteoarthritis to receive infiltrations with PRGF-Endoret or with HA (3 injections on a weekly basis). The primary outcome measure was a 50% decrease in knee pain from baseline to week 24. As secondary outcomes, we also assessed pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index; the rate of response using the criteria of the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI); and safety.<b>RESULTS: </b>The mean age of the patients was 59.8 years, and 52% were women. Compared with the rate of response to HA, the rate of response to PRGF-Endoret was 14.1 percentage points higher (95% confidence interval, 0.5 to 27.6; P = .044). Regarding the secondary outcome measures, the rate of response to PRGF-Endoret was higher in all cases, although no significant differences were reached. Adverse events were mild and evenly distributed between the groups.<b>CONCLUSIONS: </b>Plasma rich in growth factors showed superior short-term results when compared with HA in a randomized controlled trial, with a comparable safety profile, in alleviating symptoms of mild to moderate osteoarthritis of the knee.<b>LEVEL OF EVIDENCE: </b>Level I, randomized controlled multicenter trial.

Primary study

Unclassified

Journal The American journal of sports medicine
Year 2012
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Background: Arthrosis is particularly prevalent in the knee. Infiltration treatment for gonarthrosis is among the most widely used techniques in orthopaedic practice. Purpose: To compare the clinical response of hyaluronic acid (HA) and platelet-rich plasma (PRP) treatment in 2 groups of patients affected by gonarthrosis. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 120 patients affected by clinically and radiographically documented gonarthrosis were included in this study. The gonarthrosis was graded using the Kellgren-Lawrence radiographic classification scale. The 120 patients were randomized into 2 study groups in a 1:1 ratio: 60 patients received 4 intra-articular injections of PRP (specifically, autologous conditioned plasma [ACP], 5.5 mL), and 60 patients received 4 intra-articular injections of HA (20 mg/2 mL). An unblinded physician performed infiltration once a week for 4 weeks into the knee affected by clinically relevant gonarthrosis (in both groups). All patients were evaluated with the Western Ontario and McMaster (WOMAC) score before the infiltration and at 4, 12, and 24 weeks after the first injection. Results: Treatment with a local injection of ACP had a significant effect shortly after the final infiltration and a continuously improving sustained effect up to 24 weeks (WOMAC score, 65.1 and 36.5 in the HA and ACP groups, respectively; P<.001), where the clinical outcomes were better compared with the results with HA. In the HA group, the worst results were obtained for grade III gonarthrosis, whereas the clinical results obtained in the ACP group did not show any statistically significant difference in terms of the grade of gonarthrosis. The mean WOMAC scores for grade III gonarthrosis were 74.85 in the HA group and 41.20 in the ACP group (P<.001). Conclusion: Treatment with ACP showed a significantly better clinical outcome than did treatment with HA, with sustained lower WOMAC scores. Treatment with HA did not seem to be effective in the patients with grade III gonarthrosis. © 2012 The Author(s).

Primary study

Unclassified

Journal Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
Year 2012
PURPOSE: To compare the safety and efficacy of two different approaches of platelet-rich plasma (PRP) production methods as intra-articular injection treatment for knee cartilage degenerative lesions and osteoarthritis (OA). METHODS: The study involved 144 symptomatic patients affected by cartilage degenerative lesions and OA. Seventy-two patients were treated with 3 injections of platelet concentrate prepared with a single-spinning procedure (PRGF), the other 72 with 3 injections of PRP obtained with a double-spinning approach. The patients were evaluated prospectively at the enrollment and at 2, 6, and 12 months' follow-up with IKDC, EQ-VAS and Tegner scores; adverse events and patient satisfaction were also recorded. RESULTS: Both treatment groups presented a statistically significant improvement in all the scores evaluated at all the follow-up times. Better results were achieved in both groups in younger patients with a lower degree of cartilage degeneration. The comparative analysis showed similar improvements with the two procedures: in particular, IKDC subjective evaluation increased from 45.0 ± 10.1 to 59.0 ± 16.2, 61.3 ± 16.3, and 61.6 ± 16.2 at 2, 6, and 12 months in the PRGF group, and from 42.1 ± 13.5 to 60.8 ± 16.6, 62.5 ± 19.9, and 59.9 ± 20.0 at 2, 6, and 12 months in the PRP group, respectively. Concerning adverse events, more swelling (P = 0.03) and pain reaction (P = 0.0005), were found after PRP injections. CONCLUSIONS: Although PRP injections produced more pain and swelling reaction with respect to that produced by PRGF, similar results were found at the follow-up times, with a significant clinical improvement with respect to the basal level. Better results were achieved in younger patients with a low degree of cartilage degeneration. LEVEL OF EVIDENCE: II.

Primary study

Unclassified

Journal BMC musculoskeletal disorders
Year 2012
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<b>BACKGROUND: </b>Platelet rich plasma (PRP), a blood-derived product rich in growth factors, is a promising treatment for cartilage defects but there is still a lack of clinical evidence. The aim of this study is to show, through a randomized double blind prospective trial, the efficacy of this procedure, by comparing PRP to Hyaluronic Acid (HA) injections for the treatment of knee chondropathy or osteoarthritis (OA).<b>METHODS: </b>109 patients (55 treated with HA and 54 with PRP) were treated and evaluated at 12 months of follow-up. The patients were enrolled according to the following inclusion criteria: age &gt; 18 years, history of chronic (at least 4 months) pain or swelling of the knee and imaging findings of degenerative changes of the joint (Kellgren-Lawrence Score up to 3). A cycle of 3 weekly injections was administered blindly. All patients were prospectively evaluated before and at 2, 6, and 12 months after the treatment by: IKDC, EQ-VAS, TEGNER, and KOOS scores. Range of motion and knee circumference changes were measured over time. Adverse events and patient satisfaction were also recorded.<b>RESULTS: </b>Only minor adverse events were detected in some patients, such as mild pain and effusion after the injections, in particular in the PRP group, where a significantly higher post-injective pain reaction was observed (p=0.039). At the follow-up evaluations, both groups presented a clinical improvement but the comparison between the two groups showed a not statistically significant difference in all scores evaluated. A trend favorable for the PRP group was only found in patients with low grade articular degeneration (Kellgren-Lawrence score up to 2).<b>CONCLUSIONS: </b>Results suggest that PRP injections offer a significant clinical improvement up to one year of follow-up. However, conversely to what was shown by the current literature, for middle-aged patients with moderate signs of OA, PRP results were not better than those obtained with HA injections, and thus it should not be considered as first line treatment. More promising results are shown for its use in low grade degeneration, but they still have to be confirmed.

Primary study

Unclassified

Journal Blood transfusion = Trasfusione del sangue
Year 2012
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BACKGROUND: The refinement of the use of platelet-derived growth factors that has occurred over the last decade has led to a broadening of the fields of use, in particular for new treatments in orthopaedics aimed at improving tissue regeneration. MATERIALS AND METHODS: Twenty-seven patients, aged between 18 and 81 years, with a diagnosis of degenerative joint disease lasting for more than 1 year were treated. The patients were divided into two groups, one with arthritis of the knee, the other with degenerative cartilage disease of the knee. Both groups were treated with a therapeutic protocol consisting of a cycle of three infiltrations of platelet-rich plasma at weekly intervals.The extemporaneous preparation was made from a sample of about 8 mL of venous whole blood collected into a specific Fibrin Polymer 2 test-tube from RegenLab(®) and centrifuged before addition of calcium gluconate.During the initial pre-treatment evaluation, specific questionnaires were administered, the Numerical Rating Scale (NRS) for subjective measurement of pain and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); these assessments were repeated 7 days after the end of the treatment and at 6 months during the follow-up. RESULTS: The parameters evaluated improved in both groups after treatment and there was a further improvement after 6 months of follow-up; furthermore, there was a substantial decrease in pain right after the first infiltration. DISCUSSION: The patients were treated on an out-patient basis by a specifically created multidisciplinary team comprising a transfusion specialist, an orthopaedist and a radiologist, who collaborate in a symbiotic manner. The out-patient protocol exploits the regenerative properties of platelet-rich plasma, which is a low cost treatment; in practice, a diagnostic-therapeutic programme of lower intensity, but of high technical and professional quality is created. The strategy also reduces both the number of hospital services and the pharmacological support required, thereby optimising the use of health care resources.

Primary study

Unclassified

Journal American journal of physical medicine & rehabilitation / Association of Academic Physiatrists
Year 2012
OBJECTIVE: This study aimed to find a simple, cost-effective, and time-efficient method for the preparation of platelet-rich plasma (PRP), so the acquired benefits will be readily available for multiple procedures in smaller outpatient clinics and to explore the safety and efficacy of the application of PRP in the treatment of degenerative lesions of articular cartilage of the knee. DESIGN: The study was designed as a prospective, cohort study with a control group. A total of 120 patients with Grade 1, 2, or 3 osteoarthritis according to the Kellgren and Lawrence grading scale were enrolled in the study. One group of patients was treated using three intra-articular applications of PRP, and the second group of patients was given three injections of hyaluronic acid. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index and the 11-point pain intensity Numeric Rating Scale. RESULTS: On average, a 4.5-fold increase in platelet concentration was obtained in the PRP group. No severe adverse events were observed. Statistically significantly better results in the Western Ontario and McMaster Universities Osteoarthritis Index and Numeric Rating Scale scores were recorded in a group of patients who received PRP injections after a 3- and 6-mo follow-up. CONCLUSIONS: Our preliminary findings support the application of autologous PRP as an effective and safe method in the treatment of the initial stages of knee osteoarthritis. Further studies are needed to confirm these results and to investigate the persistence of the beneficial effects observed.

Primary study

Unclassified

Journal Sports health
Year 2012
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BACKGROUND: With increasing frequency, platelet-rich plasma (PRP) preparations have been used to treat cartilage lesions to regenerate tissue homeostasis and retard the progression of knee osteoarthritis (OA). PURPOSE: To determine the effectiveness of intra-articular PRP injections in active patients with knee OA and to evaluate clinical outcomes in patients with and without previous surgical treatment for cartilage lesions. STUDY DESIGN: Case series. MATERIALS AND METHODS: Fifty patients with knee OA were followed for a minimum of 12 months. All were treated with 2 intra-articular injections of autologous PRP. Twenty-five patients had undergone a previous operative intervention for cartilage lesions, whereas 25 had not. Operated patients had undergone either cartilage shaving or microfracture. Multiple evaluative scores were collected at pretreatment and at 6 and 12 months posttreatment. The required sample of patients was determined beforehand by using statistical power analysis; International Knee Documentation Committee (subjective) score was defined as the primary parameter. A P value of less than 0.05 was considered statistically significant. General linear model-repeated measure test evaluated within-time improvement for each variable for all patients. Post hoc test with Bonferroni adjustment for multiple comparisons was performed to investigate the significance in improvement within time evaluations for each variable for the total sample. The differences in improvement between operated and nonoperated patients were also investigated, as were those between sexes. RESULTS: All patients showed significant improvement in all scores at 6 and 12 months (P < 0.01) and returned to previous activities. No significant difference in improvement was found between the evaluated subgroups (P < 0.01). CONCLUSIONS: The PRP treatment showed positive effects in patients with knee OA. Operated and nonoperated patients showed significant improvement by means of diminishing pain and improved symptoms and quality of life. CLINICAL RELEVANCE: There are only a few studies of PRP treatment for cartilage on osteoarthritic knees. Different PRP products might be more or less appropriate to treat different types of tissues and pathologies. The clinical efficacy of PRP remains under debate, and a standardized protocol has not yet been established.