An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis

Aptissen

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: SYNOLIS VA 40/80; Device: SYNOLIS VA 80/160

Study type: Interventional

Funder types: Industry

Identifiers

NCT05829798

PMCF2-4ML single injection

Details and patient eligibility

About

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

Enrollment: 82 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

82 participants in 2 patient groups

SYNOLIS VA 80/160

Experimental group

Description:

SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg) Intra-articular injection

Treatment:

Device: SYNOLIS VA 80/160

SYNOLIS VA 40/80

Experimental group

Description:

SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg) Intra-articular injection

Treatment:

Device: SYNOLIS VA 40/80