Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

OVT for Epicondylosis (Tennis Elbow)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04026191
Recruitment Status : Completed
First Posted : July 19, 2019
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
Anika Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Epicondylitis, Lateral Tendinopathy, Elbow Device: OrthoVisc®-T (OVT) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 19, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020


Arm Intervention/treatment
Orthovisc-T Device: OrthoVisc®-T (OVT)
Sodium hyaluronate supplied as a 2 mL (15mg/mL) unit dose in a 3 mL glass syringe.




Primary Outcome Measures :
  1. The mean change in Elbow Pain from Baseline to 6 Months [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Diagnosis of chronic lateral epicondylosis defined as:

    1. Pain reproducible on palpation of the lateral epicondyle / common extensor origin, and
    2. Pain reproducible during resisted wrist extension
  3. Failed prior treatment for lateral epicondylosis
  4. Able and willing to provide signed informed consent.
  5. Subject must be willing to abstain from other peri-articular treatments of the elbow for the duration of the study.
  6. 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.
  7. 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.

Exclusion Criteria:

  1. History of hypersensitivity to any of the ingredients in the hyaluronan
  2. Infection or skin disease in the area of the injection site or elbow joint
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. Subject is receiving or in litigation for worker's compensation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026191


Locations
Layout table for location information
Czechia
FN Motol (University Hospital Motol) Klinika dětské a dospělé ortopedie a traumatologie 2.LF UK a FN v Motole
Praha, Czechia
MEDICAL Plus
Uherské Hradiště, Czechia
"Krajská zdravotní Masarykova nemocnice, Ústí nad Labem Ortopedické oddělení"
Ústí nad Labem, Czechia
Sponsors and Collaborators
Anika Therapeutics, Inc.
Layout table for additonal information
Responsible Party: Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04026191    
Other Study ID Numbers: OVT 16-03
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anika Therapeutics, Inc.:
Hyaluronic Acid
Sodium Hyaluronate
Additional relevant MeSH terms:
Layout table for MeSH terms
Tendinopathy
Tennis Elbow
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Arm Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents