Injectie van autologe bloedplaatjes bij epicondylitis lateralis - Platelet injection in tennis elbow

• Conditions: Tennis elbow, also known as lateral epicondylitis; MedDRA version: 9.1Level: LLTClassification code 10014971Term: Epicondylitis

• Registration Number: EUCTR2007-004947-31-NL
• Lead Sponsor: Biomet Nederland BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Man and woman with lateral epicondylitis >3 months
Baseline elbow painscore >5/10, >100/200 during resisted wrist extension
informed consent
pain by palpation of the lateral epicondyle
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

<18 years
history of any blood disorder
history of bleeding disorder
history of carpal tunnel syndrome
cervical radicupathy
system disorders such as diabetis, rheumatoid arthritis and hepatitis
uncooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow up examinations
previous surgery or corticosteroidinjections for lateral epicondylitis
active bilateral elbow tendinosis
hypothyroidism
hemoglobin above or below the following range 14,0-17,7 g/dl
hemocrit outside the following range 40,0-52,0%
platelet counts outside the following range150-400x103/dl
arthrosis or fracture of the elbow as confirmed by X ray diagnosis
do not speak Dutch

Study & Design

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