NCT03679208

sAfety PerfoRmance chitOsan osteOarthritis ViscosupplEmentation

Safety and Performance of the Intra-articular Injection of Animal-free Chitosan Biomaterial (Viscosupplementation) in Patients With Symptomatic Knee Osteoarthritis: a Pre-market Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kiomed Pharma · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

KIO014 is an innovative chitosan-based biomaterial intended for synovial fluid viscosupplementation indicated for the symptomatic treatment of knee osteoarthritis (OA). The study KIO014-APROOVE is aimed to evaluate the safety and performance of KIO014 in patients with symptomatic knee OA. A total of 100 patients will be enrolled. The study is divided in two stages. The Stage 1 cohort is the safety cohort where 10 patients will be enrolled. Stage 1 patients receiving two injections of KIO014 at day 0 and at month 3, and will be followed for 12 months post initial injection. The Stage 2 cohort is the performance cohort for 90 patients, and this stage will be randomized controlled and single-blind for the patient. In stage 2, 60 patients will receive an intra-articular injection of KIO014 (test group) and 30 patients will receive an intra-articular injection of Durolane® (control group). Patients will be followed for 6 months.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Investigational device coded KIO014	Innovative chitosan-based biomaterial intended for intraarticular injection.
DEVICE	Durolane(r) as control device	Crosslinked hyaluronic acid-based biomaterial intended for intraarticular injection.

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-05-15
• Completion: 2019-12-15
• First posted: 2018-09-20
• Last updated: 2018-09-21