An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05829850
• Other study ID #: PMCF2ML Multishot
• Status: Completed
• Phase: N/A
• Start date: December 29, 2021
• Est. completion date: January 9, 2023

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 40/80 over a period of 24 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• 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)
• VAS 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 remarkable 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

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• SYNOLIS VA 40/80
Three 2mL injections of SYNOLIS VA 40/80, one week apart

Locations

Country	Name	City	State
Poland	SPORTO oddzial na ulicy Ksiazka (2nd site location)	Lódz
Poland	SPORTO oddzial na ulicy Miedzianej	Lódz
Poland	Carolina Medical Center	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 40/80 assessed with adverse events monitoring throughout the study duration		168 days
Primary	Difference in total 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 (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 (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 (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	Pain at walking on a 100 mm VAS		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