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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: SYNOLIS VA 40/80; Device: SYNOLIS VA 80/160

• Registration Number: NCT05829798
• Lead Sponsor: Aptissen SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-14
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Study First Submitted: 2023-03-21
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYNOLIS VA 40/80	SYNOLIS VA 40/80	SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg) Intra-articular injection
SYNOLIS VA 80/160	SYNOLIS VA 80/160	SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg) Intra-articular injection

Primary Outcome Measures

Name	Time	Method
Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit	168 days	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)

Secondary Outcome Measures

Name	Time	Method
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	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)
Percentage of subjects using analgesics	up to 168 days	New NSAID / analgesics drugs usage
Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) functional severity index, as compared to D0	up to 168 days	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)
Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) stiffness severity index, as compared to D0	up to 168 days	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)
Measurement of relief satisfaction by the patient	168 days	7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Measurement of therapeutic efficacy by the investigator (assessor)	168 days	7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)

Trial Locations

Locations (3)

SPORTO Spółka z o.o.; 🇵🇱 Łódź, Poland

Klinika Chirurgii Kolana Dr Słynarskiego; 🇵🇱 Warszawa, Poland

NZOZ Carolina Medical Center - Sport Medica S.A; 🇵🇱 Warszawa, Poland