Osteoarthritis, Knee Clinical Trial
Official title:
Safety and Performance of an Intra-articular Injection of KiOmedine CM-Chitosan in Patients With Advanced Symptomatic Knee Osteoarthritis: Single-blind Randomized Controlled Trial With a 12-month Follow-up Period.
A single-blind randomized controlled design intended for the assessment of safety and performance of a single intra-articular injection of the IMD. In the study, 92 patients meeting eligibility criteria will be randomly assigned to two groups respectively of 46 subjects receiving a single injection of the IMD and 46 subjects receiving a single injection of Synvisc-One® (Hylan G-F 20) which is selected as comparator. Each patient will be blinded for the treatment he/she receives at the injection visit (single blinding). The patients will be followed for 12 months post-injection to understand long-term safety and performance effects. The study aims to evaluate the safety and performance of a single injection of KiOmedine® CM-Chitosan compared to the comparator device (Synvisc-One®) in patients with advanced symptomatic knee osteoarthritis. The non-inferiority hypothesis for the primary performance objective is that the percentage mean reduction in pain from baseline at 6 months in the KiOmedine® CM-Chitosan group is non-inferior to that of the comparator group considering a non-inferiority margin. If the hypothesis of non-inferiority is met, then superiority testing will be performed.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03895489 -
Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses
|
N/A | |
Completed |
NCT03660943 -
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
|
Phase 3 | |
Completed |
NCT04531969 -
Comparison of Outpatient and Inpatient Spa Therapy
|
N/A | |
Completed |
NCT02848027 -
Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
|
Phase 3 | |
Completed |
NCT05160246 -
The Instant Effect of Kinesiology Taping in Patients With Knee OA
|
N/A | |
Recruiting |
NCT06080763 -
Biomechanics and Clinical Outcomes in Responders and Non-Responders
|
||
Completed |
NCT03643588 -
The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
|
N/A | |
Active, not recruiting |
NCT05100225 -
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
|
Phase 2 | |
Active, not recruiting |
NCT04061733 -
New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
|
N/A | |
Completed |
NCT04051489 -
A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
|
||
Recruiting |
NCT05546541 -
Epidemiology and Nutrition
|
||
Recruiting |
NCT05447767 -
Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg
|
Phase 2 | |
Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
Not yet recruiting |
NCT03225911 -
Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis
|
N/A | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Completed |
NCT05703087 -
Positive Cueing in Knee Arthroplasty.
|
N/A | |
Not yet recruiting |
NCT06042426 -
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
|
Phase 4 | |
Completed |
NCT02901964 -
Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial
|
N/A | |
Completed |
NCT03037489 -
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
|
Phase 2 | |
Terminated |
NCT02615522 -
Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration
|