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The VergenixTM STR device is intended for the repair of non ruptured tendon injuries (Tendinopathy).
Full description
The VergenixTM STR device is an advanced Soft tissue repair device, made of lyophilized Type I rhCollagen and Calcium Chloride that will be mixed with autologous PRP prior to injection for the repair of non ruptured tendon injuries (Tendinopathy). Three (3) ml of the mixed solution will be injected into the common extensor tendon.
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Inclusion criteria
Man or woman aged 18 - 80 years old.
Clinical diagnosis of lateral epicondylitis based on site of pain, pain
elicited with active extension of the wrist in pronation and elbow
extension.
Documented ultrasonography diagnosis of common extensor
tendinosis and possible tear based on abnormal echotexture (tendon
thickening, anechoic areas, areas of hypoechogencicity, loss of
fibrillar pattern).
Chronic symptoms (equal or greater than 3 months).
PRTEE questionnaire score of at least 50 out of 100.
For child-bearing potential females, documentation of birth
control.
Signing informed consent form. -
Exclusion criteria
Acute symptom onset (less than 3 months).
History of acute elbow trauma.
History of Rheumatoid Arthritis.
History of Inflammatory disease
History of Fibromyalgia
The patient has active malignant disease of any kind. A patient who
has had a malignant disease in the past, was treated and is currently
disease-free for at least 5 years, may be considered for study entry.
The patient is treated with anti-coagulant medication
The patient previously underwent a surgery for lateral
epicondylitis.
The patient previously received local injections, including steroids
within the last 30 days
Signs of other causes for lateral elbow pain (posterior interosseous
nerve entrapment, osteochondral lesion).
Wounds around the elbow
Likely problems, in the judgment of the investigator, with maintaining follow-up.
Clinically significant abnormalities in hematology and blood
chemistry lab tests at screening that in the opinion of the
investigator might interfere with the patient's safety or participation
in the study.
Known as positive HIV, hepatitis B, or hepatitis C.
Known history of a significant medical disorder, which in the
investigator's judgment contraindicates the patient's participation.
Known hypersensitivity and/or allergy to collagen.
Drug or alcohol abuse (by history).
Pregnancy of child-bearing potential females.
Participation in another study within 30 days prior to screening
visit.
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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