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

Sponsor
University of Milan (Other)
Overall Status
Completed
CT.gov ID
NCT03211650
Collaborator
Regen Lab SA (Industry)
174
Enrollment
2
Locations
3
Arms
53.4
Actual Duration (Months)
87
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: hyaluronic Acid + platelet-rich plasma
  • Drug: hyaluronic acid
  • Drug: platelet-rich plasma
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
174 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Intra-articular Injection of Combined Hyaluronic Acid and Platelet-rich Plasma in Knee Degenerative Joint Disease
Actual Study Start Date :
Oct 14, 2016
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Mar 27, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. WOMAC score [6 months after the first intra-articular injection]

      Comparison of WOMAC total score among three treatment arms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO Milano Milan Italy 20122
    2 IRCCS Policlinico San Donato San Donato Milanese Milan Italy 20097

    Sponsors and Collaborators

    • University of Milan
    • Regen Lab SA

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pietro Randelli, MD, Full Professor, University of Milan
    ClinicalTrials.gov Identifier:
    NCT03211650
    Other Study ID Numbers:
    • ACP-HA
    First Posted:
    Jul 7, 2017
    Last Update Posted:
    Jun 14, 2021
    Last Verified:
    Jun 1, 2021
    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
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Hyaluronic Acid

    Study Results

    No Results Posted as of Jun 14, 2021