Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
NCT02861183 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2022-11-30
Summary
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).
Conditions
- Epicondylitis
- Tennis Elbow
- Epicondylosis
Interventions
- DEVICE
-
OVT (Sodium Hyaluronate)
A Peri-osteotendinous injection of OVT will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart.
- DEVICE
-
Saline
A Peri-osteotendinous injection of sterile saline will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart.
Sponsors & Collaborators
-
Anika Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
TBD TBD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-30
- Primary Completion
- 2027-04-30
- Completion
- 2027-10-31
- FDA Device
- Yes
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