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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211650
• Other study ID #: ACP-HA
• Status: Completed
• Phase: Phase 4
• Start date: October 14, 2016
• Est. completion date: March 27, 2021

Study information

• Verified date: June 2021
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 27, 2021
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• hyaluronic Acid + platelet-rich plasma
Intra-articular injections of hyaluronic acid combined with platelet-rich plasma
• hyaluronic acid
Intra-articular injections of hyaluronic acid
• platelet-rich plasma
Intra-articular injections of platelet-rich plasma

Locations

Country	Name	City	State
Italy	U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO	Milano	Milan
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milan

Sponsors (2)

Lead Sponsor	Collaborator
University of Milan	Regen Lab SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC score	Comparison of WOMAC total score among three treatment arms	6 months after the first intra-articular injection