Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-07-19
2020-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Orthovisc-T
OrthoVisc®-T (OVT)
Sodium hyaluronate supplied as a 2 mL (15mg/mL) unit dose in a 3 mL glass syringe.
Interventions
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OrthoVisc®-T (OVT)
Sodium hyaluronate supplied as a 2 mL (15mg/mL) unit dose in a 3 mL glass syringe.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Anika Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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FN Motol (University Hospital Motol) Klinika dětské a dospělé ortopedie a traumatologie 2.LF UK a FN v Motole
Prague, , Czechia
MEDICAL Plus
Uherské Hradiště, , Czechia
"Krajská zdravotní Masarykova nemocnice, Ústí nad Labem Ortopedické oddělení"
Ústí nad Labem, , Czechia
Countries
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Other Identifiers
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OVT 16-03
Identifier Type: -
Identifier Source: org_study_id