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

June 10, 2021 updated by: Pietro Randelli, MD, University of Milan

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Milano, Milan, Italy, 20122
        • U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
      • San Donato Milanese, Milan, Italy, 20097
        • IRCCS Policlinico San Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hyaluronic acid + platelet-rich plasma
Intra-articular injections of hyaluronic acid combined with platelet-rich plasma
Drug: hyaluronic Acid + platelet-rich plasma
Intra-articular injections of hyaluronic acid combined with platelet-rich plasma
Other Names:
  • Cellular Matrix/A-CP HA Kit
Active Comparator: platelet-rich plasma
Intra-articular injections of platelet-rich plasma
Drug: platelet-rich plasma
Intra-articular injections of platelet-rich plasma
Other Names:
  • RegenKit-BCT-1
Active Comparator: hyaluronic acid
Intra-articular injections of hyaluronic acid
Drug: hyaluronic acid
Intra-articular injections of hyaluronic acid
Other Names:
  • ArthroVisc40

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC score
Time Frame: 6 months after the first intra-articular injection
Comparison of WOMAC total score among three treatment arms
6 months after the first intra-articular injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Collaborators

Regen Lab SA

Investigators

  • Principal Investigator: Pietro Randelli, Professor, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2016

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

March 27, 2021

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACP-HA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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