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OpenTrials
Completed

NCT Number: NCT03211650

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hyaluronic Acid + platelet-rich plasma

Drug

Intra-articular injections of hyaluronic acid combined with platelet-rich plasma

Other names: Cellular Matrix/A-CP HA Kit

Hyaluronic acid

Drug

Intra-articular injections of hyaluronic acid

Other names: ArthroVisc40

platelet-rich plasma

Drug

Intra-articular injections of platelet-rich plasma

Other names: RegenKit-BCT-1

Primary outcomes

  1. WOMAC score

    Time frame: 6 months after the first intra-articular injection

    Comparison of WOMAC total score among three treatment arms

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

  • Regen Lab SA

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Jul 7, 2017
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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