[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519181":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":46,"locations":56,"responsibleParty":72,"collaborators":31,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":31,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":31,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":58,"whyStopped":31,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Istituto Ortopedico Rizzoli","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Leukocyte-rich Platelet rich plasma (LR-PRP)","EXPERIMENTAL","This group of patients will be treated with single injection of autologous leukocyte rich platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.",[13],"Biological: Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)",{"label":15,"type":10,"description":16,"interventionNames":17},"Leukocyte-poor Platelet rich plasma (LP-PRP)","This group of patients will be treated withsSingle injection of autologous leukocyte poor platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received.",[18],"Biological: Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)",{"label":20,"type":21,"description":22,"interventionNames":23},"Saline solution","PLACEBO_COMPARATOR","This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months following a dedicated randomization list.",[24],"Drug: Placebo (saline solution)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)","Patients will be treated with a single eco-guided injection of Autologous LR-PRP in the elbow affected by epicondylitis.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)","Patients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis.",[15],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"DRUG","Placebo (saline solution)","Patients will be treated with a single injections of saline solution in the elbow affected by epicondylitis.",[20],[42],{"name":43,"affiliation":44,"role":45},"Enrico Guerra, MD","Istituto Ortopedico Rizzoli - SC Chirurgia della spalla e del gomito","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":31,"email":50},"CONTACT","0516366567","enrico.guerra@ior.it",{"name":52,"role":48,"phone":53,"phoneExt":54,"email":55},"Roberta Licciardi, MSc","6366567","051","roberta.licciardi@ior.it",[57],{"facility":5,"status":58,"city":59,"state":31,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Bologna","40136","Italy","IT",{"type":64,"coordinates":65},"Point",[66,67],11.33875,44.49381,{"lat":67,"lon":66},[70,71],{"name":43,"role":48,"phone":53,"phoneExt":31,"email":50},{"name":52,"role":48,"phone":53,"phoneExt":54,"email":55},{"type":73,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100519181","leukocyte-rich-prp-or-leukocyte-free-prp-vs-placebo-in-the-treatment-of-epicondylitis-100519181",false,"NCT06040203","Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis","Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\nPatients with epicondylitis of the elbow:\n\n1. Patients with clinical picture of epicondylitis;\n2. Duration of symptoms \\> 3 months\n3. Ultrasound picture of short or long radial extensor carpal tendinopathy;\n4. Age \\> 18 and \\\u003C 65\n5. Both sexes;\n6. Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months;\n7. Hemoglobin \\> 11 g\u002Fdl;\n8. Platelet count \\> 150,000 plt\u002Fmm3 (Recently performed CBC examination);\n9. Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab\n10. No clinically significant electrocardiographic changes (Recently performed ECG);\n11. Ability and consent of the patient to actively participate in clinical follow-up;\n12. Signature of informed consent.\n\nExclusion Criteria:\n\n1. Patients undergoing previous surgical treatment on the epicondylar tendons;\n2. Patients undergoing epicondylar infiltration in the previous 6 months;\n3. Inability of patients to actively participate in clinical follow-up;\n4. Incapacitated patients;\n5. Patients with states of immunodepression;\n6. Patients with fibromyalgia;\n7. Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications);\n8. Patients with uncontrolled thyroid metabolic disorders;\n9. Patients abusing alcoholic beverages, drugs or medications;\n10. Patients who have taken NSAIDs in the 3 days prior to blood collection;\n11. Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw;\n12. Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated;\n13. Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab\n14. Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)","ALL","18 Years","65 Years",{"count":85,"type":86},240,"ESTIMATED","INTERVENTIONAL",[89],"NA","The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1 allocation.The objective of the study is to evaluate by means of a randomized controlled, double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or without leukocytes compared with echo-guided injection of saline for minimally invasive treatment of patients with epicondylitis resistant to conservative therapy. It will be the aim of the study to evaluate the efficacy and safety of the injection procedures by revealing the improvement and incidence of adverse events following treatment",[92],"Tennis Elbow",[94,95,96,97,98,99],"Platelet rich plasma","Leukocyte-rich PRP","Leukocyte-poor PRP","PRP","PRP injection","Double-blind randomized controlled clinical trial","2025-09-24",{"date":102,"type":103},"2025-09-29","ACTUAL",{"date":105,"type":103},"2023-03-23",{"date":107,"type":86},"2027-03",{"name":5,"class":6},1]