OVT for Epicondylosis (Tennis Elbow) (NCT04026191) | Clinical Trial Compass
CompletedNot Applicable
OVT for Epicondylosis (Tennis Elbow)
Czechia50 participantsStarted 2019-07-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The mean change in Elbow Pain from Baseline to 6 Months
. 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.