Prospective randomized study of the effect of autologous concentrated thrombocytes versus corticosteroid injections in lateral epicondylitis. - autologous thrombocytes injections in lateral epicondylitis.

• Conditions: Tenniselbow, also known as lateral epicondylitis.

• Registration Number: EUCTR2006-002198-32-NL
• Lead Sponsor: Biomet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

a. Men and women with lateral epicondylitis > 3 months
b. Baseline elbow painscore > 5/10, > 100/200 during resisted wrist extension
c. Informed consent
d. Pain by palpation of the lateral epicondyle
e. Pain that is unresponsive to physical therapy or a brace.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. < 18 years of age
b. History of any blood disorder
c. History of bleeding disorder
d. History of carpal tunnel syndrome
e. Cervical radiculopathy
f. Systemic disorders such as diabetes, rheumatoid arthritis, and hepatitis
g. Un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
h. Previous surgery or corticosteroidinjections for lateral epicondylitis
i. Active bilateral elbow tendinosis
j. Hypothyroidism
k. Hemoglobin above or below the following range 14.0-17.7 g/dl
l. Hematocrit: outside of the following range: 40.0-52.0%
m. Platelet counts outside of the following range: 150-400 x103/dl
n. Arthrosis or fracture of the elbow, as confirmed by X-ray diagnosis (AP, lateral views)
o. Do not speak Dutch

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified