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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05829798
• Other study ID #: PMCF2-4ML single injection
• Status: Completed
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2023
• Source: Aptissen SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• SYNOLIS VA 80/160
Single 4mL intra-articular injection of SYNOLIS VA 80/160
• SYNOLIS VA 40/80
Single 2mL intra-articular injection of SYNOLIS VA 40/80

Locations

Country	Name	City	State
Poland	SPORTO Spólka z o.o.	Lódz
Poland	Klinika Chirurgii Kolana Dr Slynarskiego	Warszawa
Poland	NZOZ Carolina Medical Center - Sport Medica S.A	Warszawa

Sponsors (2)

Lead Sponsor	Collaborator
Aptissen SA	Noblewell

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 assessed with adverse events monitoring throughout the study duration		168 days
Primary	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	Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis index (WOMAC) pain severity index, as compared to D0	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)	up to 168 days
Secondary	Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) functional severity index, as compared to D0	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)	up to 168 days
Secondary	Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) stiffness severity index, as compared to D0	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)	up to 168 days
Secondary	Percentage of subjects using analgesics	New NSAID / analgesics drugs usage	up to 168 days
Secondary	Measurement of relief satisfaction by the patient	7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)	168 days
Secondary	Measurement of therapeutic efficacy by the investigator (assessor)	7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)	168 days