Innovative Tool to Analyse Synovial Fluid of Patients With Knee Ostearthritis After IA Injection of Synvisc-one®

NCT04321668 | Completed

• 1 other identifier: RESYF
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this trial is to assess the clinical pertinence of an innovative analytical tool (SYNODIAG) to analyze the Synovial Fluid (SF) composition and guide the patient treatment in a Proof of Concept (PoC) study using OA patients receiving IA injection of SYNVISC ONE®.

Conditions

Knee Osteoarthritis; Intra-Articular Injection

Keywords

Osteoarthritis; food supplement; SYNVISC; Synovial Fluid analysis

Outcome Measures

Primary Outcomes (1)

• Detection of variation of the composition of Synovial Fluid after hyaluronic acid viscosupplementation in Osteoarthritis patients receiving SYNVISC-ONE® injection

  Tribological properties (i.e. the dried drop surface and the peripheral height profile) of the synovial fluid will be analyzed through optical microscopy (2D morphological examinations) in OA patients receiving SYNVISC-ONE® injection

  6 months (between T0 and T6 visit)

Secondary Outcomes (9)

• Detection of Synovial fluid tribological properties through interferometry

  6 months (between T0 and T6 visit)

• Detection of Synovial fluid molecular structural and chemical changes using a Raman confocal microscope

  6 months (between T0 and T6 visit)

• Detection of dried drops physicochemical index

  6 months (between T0 and T6 visit)

• Variation of Visual Analogue Scale for the mean knee pain at rest and while walking over the last month

  6 months (between T0 and T6 visit)

• Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire

  6 months (between T0 and T6 visit)

Other Outcomes (1)

• Correlation at each timepoint between Synovial fluid composition and osteoarthritis biological markers (optional)

  6 months (between T0 and T6 visit)

Study Arms (1)

Injection of SYNVISC-ONE

OTHER

Patients suffering from symptomatic knee osteoarthritis (OA), receiving intra-articular (IA) injection of SYNVISC-ONE® (Hylan G-F 20; 10 mL single-injection viscosupplement)

Device: Synvisc-One

Interventions

Synvisc-One DEVICE

SYNVISC-ONE® (Hylan G-F 20), 10 mL single-injection viscosupplement Status : CE marked (CE 0086) class III Medical Device The IP is used according to its usual dosage, administration and indication

Also known as: SYNVISC, Hylan G-F 20

Injection of SYNVISC-ONE

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 40 years of age with BMI ≤ 35 kg/m2
• Femorotibial knee OA (Uni- or bilateral):
• Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
• Symptomatic for more than 6 months in the most painful knee
• Eligible for knee viscosupplementation using SYNVISC-ONE®
• Knee swelling justifying SF aspiration at baseline - Able to follow the instructions of the study
• Having signed an informed consent

You may not qualify if:

• Related to the OA pathology
• Recent macro-trauma (\< 6 months) of the knee responsible of the symptomatic knee. Micro-trauma are allowed according the Investigator's discretion
• Concurrent articular disease interfering with the evaluation of OA and/or pain such as but not limited to articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis, infectious arthritis, radiculalgia in the lower limbs, arteritis, chondrocalcinosis x-rays diagnosed and Calcium PyroPhosphate Dihydrate crystal deposition disease (CPPD)
• Hemarthrosis
• Prosthesis in the target knee
• Related to treatment
• Corticosteroids injection in the target knee in the last 3 months before injection (excepted for low dose injection following SF aspiration at V1 as recommended by standard treatment guidelines)
• Hyaluronan injection in the target knee in the last 6 months before injection
• Arthroscopy in the last 3 months before injection
• Oral corticotherapy ≥ 5mg/day (in Prednisolone equivalent) in the last 3 months before injection
• Change in the dosage regimen of symptomatic slow-acting drugs for osteoarthritis (SYSADOA) or dietary supplement, i.e., curcuma extract, chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables in the last 3 months before injection
• An anticipated need for any forbidden OA treatments during the trial
• Contraindications to SYNVISC-ONE®: hypersensitivity or allergy to the product components and infections or skin diseases in the area of the injection site
• Anticoagulant anti-vitamin K (such as coumarinic) before injection
• Related to associated diseases

Sponsors & Collaborators

• Pulsalys: lead
• Artialis: collaborator

Study Sites (3)

Centre Medical Chant d'Oiseau

Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, 1150, Belgium

Location

Hopital Delta, CHIREC

Auderghem, 1160, Belgium

Location

Cliniques Universitaires Saint Luc - UCL

Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jean-Emile Dubuc, MD

  Cliniques Universitaires Saint-Luc UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Proof of Concept (PoC), monocentric, non-comparative, interventional trial

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 25, 2020
• Study Start: February 12, 2020
• Primary Completion: October 1, 2021
• Study Completion: February 15, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)