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

This study is currently recruiting participants.

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Contacts and Locations

Verified July 2017 by Pietro Randelli, MD, University of Milan

Sponsor:

Collaborator:

Regen Lab SA

Information provided by (Responsible Party):

Pietro Randelli, MD, University of Milan

ClinicalTrials.gov Identifier:

NCT03211650

First received: July 6, 2017

Last updated: July 7, 2017

Last verified: July 2017

History of Changes

Purpose

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Joint Disorders Osteoarthritis

Drug Information available for: Hyaluronic Acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Pietro Randelli, MD, University of Milan:

Primary Outcome Measures:

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


Estimated Enrollment:	175
Actual Study Start Date:	October 14, 2016
Estimated Study Completion Date:	May 30, 2019
Estimated Primary Completion Date:	November 30, 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	30 Years to 80 Years (Adult, Senior)
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211650

Contacts


Contact: Pietro Randelli, Professor	0258296413	ale.menon@me.com

Locations


Italy
U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO	Recruiting
Milano, Milan, Italy, 20122
Contact: Pietro Randelli, MD pietro.randelli@unimi.it
Contact: Alessandra Menon, PhD ale.menon@me.com
IRCCS Policlinico San Donato	Recruiting
San Donato Milanese, Milan, Italy, 20097
Contact: Filippo Randelli, MD 02-52774554 filippo.randelli@fastwebnet.it
Contact: Alessandra Menon, PhD 349-8694424 ale.menon@me.com

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

More Information


Responsible Party:	Pietro Randelli, MD, Full Professor, University of Milan
ClinicalTrials.gov Identifier:	NCT03211650 History of Changes
Other Study ID Numbers:	ACP-HA
Study First Received:	July 6, 2017
Last Updated:	July 7, 2017


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

ClinicalTrials.gov processed this record on July 11, 2017

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