To assess the residual risk of OrthoVisc-T (OVT) for the treatment of chronic lateral epicondylosis (Tennis Elbow). This trial will provide clinical data on a subject population not previously researched which have failed prior treatments for lateral epicondylosis.
Orthovisc-T is a sterile viscoelastic preparation supplied in a disposable glass syringe containing 2.0 mL of sodium hyaluronate (15 mg/mL) dissolved in physiological saline. The Orthovisc-T device is intended to relieve pain and restore function in tendons affected by chronic lateral epicondylosis. The hyaluronic acid solution provides extracellular supplementation of the elbow with lateral epicondylosis, lubricating and hydrating the affected site, thereby providing the ideal environment for healing of the damaged tissue. The objective of the study is to evaluate the residual risk of two peri-osteotendinous injections of Orthovisc-T spaced one week apart for the relief of elbow pain and to restore function in patients with lateral epicondylosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Sodium hyaluronate supplied as a 2 mL (15mg/mL) unit dose in a 3 mL glass syringe.
FN Motol (University Hospital Motol) Klinika dětské a dospělé ortopedie a traumatologie 2.LF UK a FN v Motole
Prague, Czechia
MEDICAL Plus
Uherské Hradiště, Czechia
"Krajská zdravotní Masarykova nemocnice, Ústí nad Labem Ortopedické oddělení"
Ústí nad Labem, Czechia
The mean change in Elbow Pain from Baseline to 6 Months
The mean change in Pain After Grip from Baseline to 6 Months as measured with a 0-10 Likert Scale comparing the OVT group to Baseline measurements.
Time frame: From baseline to 6 months
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