CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
Hyaluronic Acid +2 moredrug
Likely dose
Hyaluronic Acid 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03825133
NCT03825133Phase 4Completed
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The Comparison of Knee Osteoarthritis Treatment With Single-dose of Bone Marrow Aspirate Concentrate, Single-dose of Leukocyte Rich Platelet Rich Plasma and 3 Injection of High Molecular Weight Hyaluronic Acid-A Randomized Clinical Trial

Clinical Center of Vojvodina·interventional·Posted Jan 31, 2019·Updated Feb 7, 2019

In Brief

A Phase 4 clinical trial evaluating Bone Marrow Aspirate Concentrate, Leukocyte Rich Platelet Rich Plasma, and 1 other intervention for Knee Osteoarthritis. Completed, enrolled 180 participants across 1 site.

Detailed Summary

The aim of this study is to compare therapeutic and clinical effects of intra-articular injection of Bone Marrow Aspirate Concentrate (BMAC), inta-articular injection of Leukocyte Rich Platelet Rich plasma (LR-PRP) and 3 weekly doses of high molecular weight of Hyaluronic acid for the treatment of osteoarthritis (OA) of the knee ( KL scale II-IV).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
CountriesSerbia
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 31, 2019
Enrollment StartApr 1, 2016
Primary CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.4 years ago

Interventions

Bone Marrow Aspirate Concentrateprocedure

Bone marrow ( 100 ml) is aspirated from proximal tibia, concentrated in Arthrex Angel Centrifuge, and after concentration 6 ml of BMAC is injected in the knee

Leukocyte Rich Platelet Rich Plasmaprocedure

Blood sample is taken ( 100 ml), centrifuged in Arthrex Angel Centrifuge and after double spinning process about 6 ml of PRP is injected in the knee

Hyaluronic Aciddrug

Three injections of Cartinorm (1% Sodium Hyaluronat (20mg/2 ml) by Goodwill Pharma) is injected in the knee weekly