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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211650
Recruitment Status : Active, not recruiting
First Posted : July 7, 2017
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Regen Lab SA
Information provided by (Responsible Party):
Pietro Randelli, MD, University of Milan

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
Knee Osteoarthritis Drug: hyaluronic Acid + platelet-rich plasma Drug: hyaluronic acid Drug: platelet-rich plasma Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 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 : October 14, 2016
Actual Primary Completion Date : November 30, 2018
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: RegenKit-BCT-1

Active Comparator: hyaluronic acid
Intra-articular injections of hyaluronic acid
Drug: hyaluronic acid
Intra-articular injections of hyaluronic acid
Other Name: ArthroVisc40




Primary Outcome Measures :
  1. WOMAC score [ Time Frame: 6 months after the first intra-articular injection ]
    Comparison of WOMAC total score among three treatment arms



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211650


Locations
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Italy
U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milano, Milan, Italy, 20122
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy, 20097
Sponsors and Collaborators
University of Milan
Regen Lab SA
Investigators
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Principal Investigator: Pietro Randelli, Professor Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

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Responsible Party: Pietro Randelli, MD, Full Professor, University of Milan
ClinicalTrials.gov Identifier: NCT03211650    
Other Study ID Numbers: ACP-HA
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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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:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents