OVT for Epicondylosis (Tennis Elbow)

NCT04026191 | Completed

• 1 other identifier: OVT 16-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Epicondylitis, Lateral; Tendinopathy, Elbow

Keywords

Hyaluronic Acid; Sodium Hyaluronate

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 6 months

Study Arms (1)

Orthovisc-T

OTHER

Device: OrthoVisc®-T (OVT)

Interventions

OrthoVisc®-T (OVT) DEVICE

Sodium hyaluronate supplied as a 2 mL (15mg/mL) unit dose in a 3 mL glass syringe.

Orthovisc-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Diagnosis of chronic lateral epicondylosis defined as:
• Pain reproducible on palpation of the lateral epicondyle / common extensor origin, and
• Pain reproducible during resisted wrist extension
• Failed prior treatment for lateral epicondylosis
• Able and willing to provide signed informed consent.
• Subject must be willing to abstain from other peri-articular treatments of the elbow for the duration of the study.
• Subject is willing to discontinue all analgesics including NSAIDs, except acetaminophen/paracetamol, at least seven days before the treatment injection and through the completion of the study.
• Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams per day per the package insert) for the treatment of joint pain for the duration of the study. At least forty-eight hours prior to the Baseline Visit and each follow-up visit, the subject is willing to discontinue use of acetaminophen/paracetamol.

You may not qualify if:

• History of hypersensitivity to any of the ingredients in the hyaluronan
• Infection or skin disease in the area of the injection site or elbow joint
• Subject received a peri-articular injection of Hyaluronic Acid (HA) and/or steroid in either elbow within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either elbow during the course of this study.
• Known inflammatory or autoimmune disorders, or other pre-existing medical conditions that, in the opinion of the investigator, could impact healing or affect the ability of the subject to complete the study and comply with the study requirements.
• Subject is taking medications at the time of signing the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
• Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index elbow only) corticosteroid within 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index elbow is allowed.
• Subject is a woman who is pregnant or breastfeeding at the Screening Visit or a woman of child bearing potential who refuses to use effective contraception during the course of the study.
• Subject was involved in any other research study involving an investigational product, or a new application of an approved product, within 60 days of signing the ICF.
• Subject is receiving or in litigation for worker's compensation.

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

Study Sites (3)

FN Motol (University Hospital Motol) Klinika dětské a dospělé ortopedie a traumatologie 2.LF UK a FN v Motole

Prague, Czechia

Location

MEDICAL Plus

Uherské Hradiště, Czechia

Location

"Krajská zdravotní Masarykova nemocnice, Ústí nad Labem Ortopedické oddělení"

Ústí nad Labem, Czechia

Location

MeSH Terms

Conditions

Tennis Elbow; Elbow Tendinopathy

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 19, 2019
• Study Start: July 19, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 8, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)