Intra-articular PVA Hydrogel in Knee Osteoarthritis

NCT04693104 | Completed

• 1 other identifier: PVA-001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This multicentre, prospective, randomized, double-blind, active-controlled, parallel group clinical investigation is aimed to assess the safety and the clinical performance over 6 months of a single intra-articular injection of PVA Hydrogel, novel polyvinyl alcohol preparation, as compared to hyalan G-F20, (Synvisc-One®) one of the most commonly used and best performing hyaluronic acid based products, in patients with symptomatic knee osteoarthitis (OA).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Adverse Events at the injection site (target knee)

  patient reported symptom and/or investigator detected clinical sign

  6 months

• Adverse Device Events

  AEs considered as related to the device and/or to the IA procedure.

  6 months

Secondary Outcomes (10)

• Device Deficiencies

  6 months

• Adverse Events

  6 months

• Physical examination

  6 months

• Blood pressure

  6 months

• Pulse rate

  6 months

Study Arms (2)

PVA Hydrogel

EXPERIMENTAL

PVA Hydrogel (Rottapharm Biotech, Monza): 2 mL prefilled syringe for intra-articular injection

Device: PVA Hydrogel

Synvisc-One®

ACTIVE COMPARATOR

Synvisc-One® (Genzyme Corporation, Ridegield, New Jersey, USA): 6 mL prefilled syringe for intra-articular injection

Device: Synvisk-One®

Interventions

PVA Hydrogel DEVICE

PVA Hydrogel will be supplied in 2 mL sterile and endotoxins-free pre-filled syringes containing a biocompatible polyvinyl alcohol crosslinked (PVA CL, main component) and buffered water for injections.

PVA Hydrogel

Synvisk-One® DEVICE

Synvisc One® (comparator) will be supplied in a 6 mL sterile and non-pyrogenic syringe containing containing Hylan polymers (hylan A + hylan B) (main component), sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and water for injections.

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:

• Signed and dated informed consent obtained before undergoing any clinical-investigation-related procedure.
• Male or female aged between 40 and 80 years.
• Documented diagnosis of primary OA of the knee, based on the clinical and radiological American College of Rheumatology (ACR) criteria for knee OA:
• Knee pain,
• X-ray osteophytes,
• at least one of the following: (a) age \>50 years; (b) morning stiffness \<30 minutes in duration; (c) crepitus on active motion.
• Grade II-III according to the Kellgren and Lawrence classification (X-ray evidence at enrolment or within the previous 12 months).
• Knee OA symptoms for at least six months.
• Failure to respond (i.e. did not respond sufficiently) to analgesics and/or regular NSAIDs, or proven intolerance to regular use of NSAIDs or to weak opioids analgesics.

You may not qualify if:

• Ability and willingness to communicate, participate, and comply with the requirements and scheduled procedures of the clinical investigation.
• (a) Medical history and Concomitant Diseases related criteria
• Presence of isolated or predominantly symptomatic patellofemoral OA of the knee (i.e. pain when climbing stairs or forcing the patient to extend his leg when sitting on a low sit).
• Presence of secondary osteoarthritis and/or other rheumatic diseases. In particular, history or presence of the following diseases should be excluded: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone, articular fracture, ochronosis, acromegaly, haemocromatosis, Wilson's disease, primary osteochondromatosis.
• Contralateral (i.e. non-target) knee pain \>3 on the NRS
• Any knee OA treatment for both knees (other than the clinical investigation viscosupplementation of the target knee) anticipated within the next 6 months.
• Presence of pain (any severity) in the ipsilateral and/or contralateral hip.
• Presence of disease of the spine or other lower extremity joints of sufficient severity to affect the clinical investigation assessments.
• Anterior cruciate ligament repair, reconstruction or injury in the target knee within the previous 3 years.
• Cartilage repair/surgery in the target knee within the previous 3 years.
• Any surgery in the lower limbs within the previous 12 months
• Any planned surgery of the lower limbs during the clinical investigation period.
• Significant articular deformities of the lower limbs, i.e. major dysplasia and congenital abnormalities.
• Presence of varus or valgus knee deformity ≥ 8°.
• History or presence of osteonecrosis in the lower limbs.

Sponsors & Collaborators

• Rottapharm Biotech: lead

Study Sites (1)

Lubelskie Centrum Diagnostyczne

Świdnik, 21-040, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tomaz Blicharski

  Lubelskie Centrum Diagnostyczne, Swidnik, Poland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Given the impossibility of obtaining identical presentations of the compared interventions, double-blind conditions will be ensured by appointing at each site one "injector investigator" in charge only of the administration of the treatments and one "clinical assessor investigator" as Outcome Assessor, in charge of all safety and efficacy assessments, who will remain always blinded to the treatment. Patient blinding will be ensured by avoiding visual access to the injection field by the use of a screen between the patient and his/her knee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: January 5, 2021
• Study Start: October 1, 2019
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)