NCT05422976CompletedNot Applicable
Safety and Tolerability of a Single Intra-articular Highly Concentrated Hyaluronic Acid Injection in the Treatment of Symptomatic Knee Osteoarthritis : Pilot, 6-months, Open-label, Single-arm Investigation
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aptissen SA
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Safety and tolerability
Study Overview
Brief Summary
Prospective, single arm, pilot study to assess the safety and tolerability of a single intra-articular injection of EVI-01 for the treatment of symptomatic knee osteoarthritis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eighteen (18) years old or above;
- •Patient signed informed consent form;
- •Patients with stable symptoms related to knee osteoarthritis for at least 3 months prior to screening;
- •Failure, inadequate response or intolerance to analgesics and/or NSAIDs or low-grade opioids;
- •Kellgren-Lawrence radiographic stage: II-III diagnosed in the previous 12 months;
- •WOMAC average pain index score > 40 mm and < 90 (on a VAS 0-100 mm) on the knee to be treated;
- •Difference ≥ 10 mm between the WOMAC average pain score of the knee to be treated and WOMAC average pain score of the contralateral knee at screening;
- •Body Mass Index (BMI) inferior to 35 kg/m2 (weight/height).
Exclusion Criteria
- •Concomitant inflammatory joint disorder;
- •Had received previous visco-supplementation treatment in the study knee within 6 months or intra articular corticosteroids within 3 months* prior to inclusion;
- •Infection in or around the study knee;
- •Relevant skin disease in the area of injection site;
- •Documented presence of injury or trauma of the study knee at screening, including evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments in the study knee;
- •History of allergy or intolerance to sodium hyaluronate;
- •Documented presence of osteonecrosis in one or both knees;
- •Inability to understand the study procedure;
- •Participation in another clinical trial within 30 days prior to screening;
- •Ongoing therapy with daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment. If dose < 101 mg, it must be maintained during the study;
- •Pregnant or breast-feeding at inclusion.
- •1 month = 30 days
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: 6 months
Primary objective of this study is to assess the safety and tolerability of EVI-01 following single intraarticular administration in the knee joint, assessed with adverse events monitoring throughout the follow up duration of six months.
Secondary Outcomes
- Change in patient-reported pain intensity(7 days)
- Change in WOMAC index(6 months)
- Patient satisfaction for the overall treatment effect(6 months)
- Physician satisfaction for the overall treatment effect(6 months)
Investigators
Study Sites (2)
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