Clinical trial NCT05829798: An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
Official title: An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee Osteoarthritis
Hyaluronic acid
Lead sponsor: Aptissen SA
Sponsor class: INDUSTRY
Collaborators: name: Noblewell
First posted: 2023-04-26
Enrollment: 82
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicentre, independent assessment study on SYNOLIS VA 80/160 and SYNOLIS VA 40/80 over a period of 24 weeks


Eligibility criteria: Inclusion Criteria:

* Patient between 35 and 75 years old
* Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:

  * Knee pain
  * Positive radiography (presence of osteophytes)
  * Morning stiffness \< 30 min and/or crepitus while walking
* Symptoms related to knee osteoarthritis for at least 6 months
* Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids
* Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography)
* WOMAC pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated
* Contralateral knee pain \< 10 mm (VAS) compared to treated knee
* Patient signed inform consent form-

Exclusion Criteria:

* Inability to understand the study or language used to be informed/sign the consent
* Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial
* Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion
* Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion
* Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion
* Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion
* Rheumatoid arthritis, joint condition or any other inflammation and arthritis
* Lupus
* Dermatological disorder or any epidermal conditions that prevent an intraarticular injection
* Visible joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella
* Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee
* Osteonecrosis (1 or both knees)
* Daily dosage \> 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose \< 101 mg, must be maintained during the study
* Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA
* Fibromyalgia
* Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study
* Excessive and repeated consumption of alcohol or illicit substances
* Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)

Primary outcomes:
measure: Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit
timeFrame: 168 days
Secondary outcomes:
measure: Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis index (WOMAC) pain severity index, as compared to D0
timeFrame: up to 168 days
measure: Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) functional severity index, as compared to D0
timeFrame: up to 168 days
measure: Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) stiffness severity index, as compared to D0
timeFrame: up to 168 days
measure: Percentage of subjects using analgesics
timeFrame: up to 168 days
measure: Measurement of relief satisfaction by the patient
timeFrame: 168 days
measure: Measurement of therapeutic efficacy by the investigator (assessor)
timeFrame: 168 days
Other outcomes:
measure: Safety and tolerability of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 assessed with adverse events monitoring throughout the study duration
timeFrame: 168 days
Locations:
city: Warszawa
country: Poland
facility: Klinika Chirurgii Kolana Dr Słynarskiego
city: Warszawa
country: Poland
facility: NZOZ Carolina Medical Center - Sport Medica S.A
city: Łódź
country: Poland
facility: SPORTO Spółka z o.o.
Study officials:
References: