Trial | NCT03211650  Report issue

Title

Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis
Efficacy of Intra-articular Injection of Combined Hyaluronic Acid and Platelet-rich Plasma in Knee Degenerative Joint Disease

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    174
The purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.
Study Started
Oct 14
2016
Primary Completion
Nov 30
2018
Study Completion
Mar 27
2021
Last Update
Jun 14
2021

Drug hyaluronic Acid + platelet-rich plasma [platelet-rich plasma, hyaluronic acid]

Intra-articular injections of hyaluronic acid combined with platelet-rich plasma

  • Other names: Cellular Matrix/A-CP HA Kit

Drug hyaluronic acid

Intra-articular injections of hyaluronic acid

  • Other names: ArthroVisc40

Drug platelet-rich plasma

Intra-articular injections of platelet-rich plasma

  • Other names: RegenKit-BCT-1

hyaluronic acid + platelet-rich plasma Experimental

Intra-articular injections of hyaluronic acid combined with platelet-rich plasma

platelet-rich plasma Active Comparator

Intra-articular injections of platelet-rich plasma

hyaluronic acid Active Comparator

Intra-articular injections of hyaluronic acid

Criteria 

Inclusion criteria:

Knee pain for 4 months;
Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3;
Patients able to understand the study conditions and willing to participate for its entire duration;
Patients who signed written informed consent.

Exclusion criteria:

Severe knee osteoarthritis of grade 4;
Diabetes mellitus;
Rheumatoid arthritis;
Ongoing malignancies;
Certified allergic reactions towards the administered drugs ;
Malalignment of mechanical axis of the lower limb (varus > 10 °, valgus > 10 °);
Coagulopathies;
Severe cardiovascular diseases;
Ongoing infections;
Immunodepression;
Anticoagulants or anti-platelet agents;
Haemoglobin < 11 g/dl;
Platelet count < 150,000/mm^3
Drug addiction;
Alcoholism;
Psychiatric disease;
Pregnancy or breastfeeding.
No Results Posted