Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome
NCT ID: NCT04661111
Last Updated: 2020-12-10
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
31 participants
INTERVENTIONAL
2016-06-13
2018-06-28
Brief Summary
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Detailed Description
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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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Hymovis ONE Arm
Hymovis® ONE (32 mg/4 ml) intra-articular mono injection. Patients will be followed during 12 months including 6 visits.
Hymovis® ONE (32 mg/4 ml)
Hymovis® ONE is a clear hydrogel. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process. Hymovis® ONE is a CE-marked Class III Medical Device intended for intra-articular injection.
Interventions
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Hymovis® ONE (32 mg/4 ml)
Hymovis® ONE is a clear hydrogel. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process. Hymovis® ONE is a CE-marked Class III Medical Device intended for intra-articular injection.
Eligibility Criteria
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Inclusion Criteria
2. an active life-style, professional or regular casual sport player (people who plays sport or trains themselves at least 2-3 times per week).
3. diagnosis of knee osteoarthritis will be based upon a standing weight bearing knee X-ray at Screening or an X-ray performed within 6 months prior to screening. The radiograms must be classified as a Kellgren and Lawrence Grade I-III for osteoarthritis of the knee.
4. a knee VAS pain score, within 48 hours before the visit.
5. patients must have had all analgesic/anti-inflammatory drugs discontinued for 2 weeks prior to Baseline except for acetaminophen.
Exclusion Criteria
2. Surgical procedure of the studied joint within the previous 12 months prior to Screening.
3. Ligament reconstruction in the target knee within 1 year
4. Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis
5. Intra-articular or local peri-articular corticosteroid injections to the study joint/knee within the previous 3 months prior to screening or to any other joint (beside the study joint) or soft tissue area within the previous month prior to Screening.
6. Any corticosteroid within the previous month. Steroid inhalants are permitted if the patient has been on a stable regimen for the past month prior to Screening and remains on this regimen throughout the course of the trial.
7. Intra-articular hyaluronan in the studied joint within the previous 6 months prior to Screening.
8. History of allergic reaction to an intra-articular Hyaluronic acid injection
9. Use of glucosamine- or chondroitin sulfate-containing products unless the patient is on stable doses for at least 4 months prior to Screening and willing to remain on these stable doses throughout the course of the trial.
10. Patients with X-ray findings of acute fractures, severe loss of bone density, avascular necrosis and/or severe deformity.
11. Axial deviation of the lower limbs higher than 20 degrees in valgus or varus on standing X-ray.
12. Symptomatic osteoarthritis of either hip, contralateral knee or spine that may interfere with functional assessment of the signal knee.
13. Clinically significant medio-lateral and/or anterior-posterior instability.
14. Osteonecrosis of either knee.
15. If patients are receiving or performing physical therapy at Screening, this physical therapy regimen has not been stable during the one-month preceding Screening and the patient is not willing to maintain the same regimen throughout the course of the trial.
16. Patients with Kellgren-Lawrence Stage IV osteoarthritis of the knee (i.e.,in grade IV large osteophytes, marked narrowing, severe sclerosis, and definite deformity).
17. Hemiparesis of the lower limbs
18 Years
65 Years
ALL
No
Sponsors
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Fidia Farmaceutici s.p.a.
INDUSTRY
Responsible Party
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Locations
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Università di Roma "La Sapienza", Azienda Policlinico Umberto I, Roma
Roma, , Italy
Countries
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Other Identifiers
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EQL2-15-01
Identifier Type: -
Identifier Source: org_study_id