Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis

University of Milan

Status and phase: Completed; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: hyaluronic acid; Drug: hyaluronic Acid + platelet-rich plasma; Drug: platelet-rich plasma

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03211650

ACP-HA

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 3 patient groups

hyaluronic acid + platelet-rich plasma

Experimental group

Description:

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

Treatment:

Drug: hyaluronic Acid + platelet-rich plasma

platelet-rich plasma

Active Comparator group

Description:

Intra-articular injections of platelet-rich plasma

Treatment:

Drug: platelet-rich plasma

hyaluronic acid

Active Comparator group

Description:

Intra-articular injections of hyaluronic acid

Treatment:

Drug: hyaluronic acid