Clinical trial NCT05422976: EVI-01-IT Safety Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: highly concentrated hyaluronic acid
knee osteoarthritis
Lead sponsor: Aptissen SA
Sponsor class: INDUSTRY
Collaborators: name: Donawa Lifescience
First posted: 2022-06-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Change in patient-reported pain intensity
timeFrame: 7 days
measure: Change in WOMAC index
timeFrame: 6 months
measure: Patient satisfaction for the overall treatment effect
timeFrame: 6 months
measure: Physician satisfaction for the overall treatment effect
timeFrame: 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
affiliation: IRCCS Istituto Ortopedico Rizzoli
name: Stefano Zaffagnini, MD
role: PRINCIPAL_INVESTIGATOR
References: