Epicondylitis, LateralNCT04026191
OVT for Epicondylosis (Tennis Elbow)
A study testing OrthoVisc®-T (OVT) in people with Epicondylitis, Lateral and Tendinopathy, Elbow, run by Anika Therapeutics, Inc. at 3 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epicondylitis, Lateral, Tendinopathy, Elbow
- What is being tested?
- OrthoVisc®-T (OVT)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesCzechia
- Study dates
- 19 Jul 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
FN Motol (University Hospital Motol) Klinika dětské a dospělé ortopedie a traumatologie 2.LF UK a FN v Motole
Prague
MEDICAL Plus
Uherské Hradiště
"Krajská zdravotní Masarykova nemocnice, Ústí nad Labem Ortopedické oddělení"
Ústí nad Labem
About this study
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)
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.
Read the 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
- Being tested
- OrthoVisc®-T (OVT)
- Keywords
- Hyaluronic Acid, Sodium Hyaluronate
- Medical subject headings
- Tennis Elbow, Elbow Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoVisc®-T (OVT)Device
Sodium hyaluronate supplied as a 2 mL (15mg/mL) unit dose in a 3 mL glass syringe.
| Study group | Role | What they receive |
|---|---|---|
| Orthovisc-T | Other | Not described Receives: Device: OrthoVisc®-T (OVT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start19 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis, LateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anika Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026191
- Sponsor's protocol ID
- OVT 16-03
- Status last verified
- Dec 2021
- First submitted
- 10 Jul 2019
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04026191
- Acronym / sponsor ID
- OVT 16-03
- Conditions
- Epicondylitis, Lateral, Tendinopathy, Elbow
- Keywords
- Hyaluronic Acid, Sodium Hyaluronate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Anika Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthovisc-T | Other | Device: OrthoVisc®-T (OVT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older
- Diagnosis of chronic lateral epicondylosis defined as:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrthoVisc®-T (OVT)Sodium hyaluronate supplied as a 2 mL (15mg/mL) unit dose in a 3 mL glass syringe. | Device | Orthovisc-T |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OrthoVisc®-T (OVT) in people with Epicondylitis, Lateral and Tendinopathy, Elbow, run by Anika Therapeutics, Inc. at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in Elbow Pain from Baseline to 6 Months (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.