A clinical trial to assess the efficacy and safety of platelet concentrates for the treatment of tennis elbow.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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

• 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end point : efficiency<br>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