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

NCT05829798 | Completed

• 1 other identifier: PMCF2-4ML single injection
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Knee Osteoarthritis; Hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit

  The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)

  168 days

Secondary Outcomes (6)

• Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis index (WOMAC) pain severity index, as compared to D0

  up to 168 days

• Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) functional severity index, as compared to D0

  up to 168 days

• Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) stiffness severity index, as compared to D0

  up to 168 days

• Percentage of subjects using analgesics

  up to 168 days

• Measurement of relief satisfaction by the patient

  168 days

Other Outcomes (1)

• Safety and tolerability of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 assessed with adverse events monitoring throughout the study duration

  168 days

Study Arms (2)

SYNOLIS VA 80/160

EXPERIMENTAL

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

Device: SYNOLIS VA 80/160

SYNOLIS VA 40/80

EXPERIMENTAL

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

Device: SYNOLIS VA 40/80

Interventions

SYNOLIS VA 80/160 DEVICE

Single 4mL intra-articular injection of SYNOLIS VA 80/160

SYNOLIS VA 80/160

SYNOLIS VA 40/80 DEVICE

Single 2mL intra-articular injection of SYNOLIS VA 40/80

SYNOLIS VA 40/80

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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-

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• Aptissen SA: lead
• Noblewell: collaborator

Study Sites (3)

SPORTO Spółka z o.o.

Lodz, 09-038, Poland

Location

Klinika Chirurgii Kolana Dr Słynarskiego

Warsaw, 02-672, Poland

Location

NZOZ Carolina Medical Center - Sport Medica S.A

Warsaw, 02-757, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 26, 2023
• Study Start: January 14, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

PL (3)