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Completed

NCT Number: NCT02958761

Treatment of Knee Arthrosis With Platelet-derived Growth Factors vs. Hyaluronic Acid.

Primary aim of this trial was to assess efficacy three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales and of number of adverse events.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Intra-articular injections of hyaluronic acid are effective in improving symptoms and slow disease progression, but are not able to revert the damage mechanism and trigger cartilage healing.

Growth factors included in PRP could stimulate cartilage repair, normalize synovial fluid viscoelasticity, induce a correction in tissue damage, improve articular function, control pain and ameliorate quality of life.

Primary aim of this trial was to assess, among patients with grade II/III osteoarthrosis of the knee, efficacy (as determined by improvement at MRI 6 months after the first injection) of three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales (WOMAC, Lysholm, Tegner Knee, Scale, AKS, Lequesne, VAS) and of number of adverse events.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • grade II/III OA of the knee demonstrated at MRI17,18, according to Shahriaree Classification System - modified
  • no previous OA treatment with local hyaluronic acid or steroid injections
  • ife expectancy >1 year
  • no ongoing pregnancy
  • ability to understand and complete clinical and functional scales Lysholm, WOMAC, AKS, VAS
  • written consent.

Treatment and study plan

intraarticular injections of platelet lysate

Biological

Hyaluronic acid

Drug

intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals

Primary outcomes

  1. Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate

    Time frame: Six months after the last infiltration

    Each knee was improvement, from baseline, by at least one degree the maximum MRI score (Shahriaree Classification System - modified) at 6 month

Secondary outcomes

  1. WOMAC functional scale

    Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year

    multilevel generalized linear models (for panel-data) with interaction between time and treatment group

  2. Lysholm functional scale

    Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year

    multilevel generalized linear models (for panel-data) with interaction between time and treatment group

  3. Tegner Knee functional scale

    Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year

    multilevel generalized linear models (for panel-data) with interaction between time and treatment group

  4. AKS functional scale

    Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year

    multilevel generalized linear models (for panel-data) with interaction between time and treatment group

  5. Lequesne functional scale

    Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year

    multilevel generalized linear models (for panel-data) with interaction between time and treatment group

  6. VAS for pain

    Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year

    multilevel generalized linear models (for panel-data) with interaction between time and treatment group

  7. Adverse event

    Time frame: 1 year

    number of patients and knees with adverse event (any); anticipated potential adverse events were infection, anaphylaxis, hematoma

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

Treatment of Knee Arthrosis: Platelet-derived Growth Factors vs. Hyaluronic Acid. A Phase II-III Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2016
Registry last updated
Nov 9, 2016

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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