NCT04026191

OVT for Epicondylosis (Tennis Elbow)

A Prospective, Open-Label, Multi-Center Post-Market Clinical Follow-Up Study to Evaluate the Residual Risk of OrthoVisc®-T (OVT) in the Treatment of Chronic Lateral Epicondylosis (Tennis Elbow)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Anika Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Epicondylitis, Lateral
• Tendinopathy, Elbow

Interventions

Type	Name	Description
DEVICE	OrthoVisc®-T (OVT)	Sodium hyaluronate supplied as a 2 mL (15mg/mL) unit dose in a 3 mL glass syringe.

Timeline

• Start date: 2019-07-19
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-07-19
• Last updated: 2021-12-08

Locations

3 sites across 1 country: Czechia