Clinical Trials Logo
  1. Home
  2. Knee Osteoarthritis
  3. NCT03679208

sAfety PerfoRmance chitOsan osteOarthritis ViscosupplEmentation — APROOVE  

Knee Osteoarthritis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03679208
Study type Interventional
Source Kiomed Pharma
Contact
Status Not yet recruiting
Phase N/A
Start date October 15, 2018
Completion date December 15, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04651673 - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed NCT05677399 - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise. N/A
Active, not recruiting NCT04043819 - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis Phase 1
Recruiting NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee Phase 3
Completed NCT05014542 - Needling Techniques for Knee Osteoarthritis N/A
Recruiting NCT05892133 - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty N/A
Recruiting NCT05528965 - Parallel Versus Perpendicular Technique for Genicular Radiofrequency N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting NCT02003976 - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone N/A
Active, not recruiting NCT04017533 - Stability of Uncemented Medially Stabilized TKA N/A
Completed NCT04779164 - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis N/A
Recruiting NCT04006314 - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis N/A
Recruiting NCT05423587 - Genicular Artery Embolisation for Knee Osteoarthritis II N/A
Enrolling by invitation NCT04145401 - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting NCT03781843 - Effects of Genicular Nerve Block in Knee Osteoarthritis N/A
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05324163 - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis Phase 3
Completed NCT05529914 - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis N/A
Recruiting NCT05693493 - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA? N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A