Lateral epicondylitis MedDRA version: 17.0 Level: LLT Classification code 10024032 Term: Lateral epicondylitis System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Autologous Platelet Rich Plasma
Product Name: Autologous Platelet Rich Plasma
Product Code: aPRP
Pharmaceutical Form: Injection
Trade Name: Mesocain 1%
Product Name: Mesocain 1%
Product C
Sponsors
Fakultní nemocnice Ostrava
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18-60 years old men or women - Disability elbow withought arthrosis or a low grade of arthrosis / less than 2-nd degree of Kellgrenn classification of x-ray / - Finding epicondylitis verified by clinical examination, possibly with the addition of Doppleromerie, scintigraphy, or MRI thermometry - At least some positive effect of the application of local anesthetic into the treated sites at least l M prior to study - Agrees with the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with acute or chronic infection or acute inflammatory complications ( general or local ), also patients treated with antibiotic therapy for suspected infectious disease during the 6 weeks before inclusion in the study or in the event of Infectious complications in observed elbow least 6 month before study . • Pregnant and nursing women and women of childbearing potential not using reliable contraceptive method. • Presumption of survival for less than two years . • Patients with severe disorders of blood coagulation and platelet disorders • Patients with bone marrow disease in history • Kidney disease in the last stage with dependence on dialysis •Using Immunosuppressive drugs • Known abuse of alcohol or drugs, or other factors which might affect the subject's behavior during the study or the interpretation of results • The patient , whose participation is considered by the investigator to be inappropriate • Unwillingness or inability of the patient to give informed consent to inclusion in the study • Application of glucocorticoids in his elbow less than 6 weeks prior to enrollment . • Rehabilitation measures less than 6 weeks prior to enrollment . • Surgical procedure less than 3month prior to enrollment . • X-ray signs of osteoarthritis of the elbow - over II degree by Kellgren •Consequences of severe injuries such as bone fracture , resulting in nonanatomical position.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: main objective of security : is aplication of PRP secure for treatement of lateral epipcondylitis?;Secondary Objective: Secondary objective of efficiency : is aplication of PRP effective for treatement of lateral epipcondylitis compared to corticoid´s standard treatement?;Primary end point(s): Primary end point : safety Safety will be proved by comparing the frequency of adverse reactions of applications in both arms of the study.;Timepoint(s) of evaluation of this end point: 12 month follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end point : efficiency The effectiveness of treatment with PRP will be proved by comparing the results of the two branches of study via a visual analogue scale of pain and by DASH score (Disabilities of arm, shoulder & hand).;Timepoint(s) of evaluation of this end point: 12 month follow up | — |
Countries
Czech Republic
Contacts
Public ContactEthical comittee
Fakultní nemocnice Ostrava
Outcome results
None listed