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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals
Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate
Each knee was improvement, from baseline, by at least one degree the maximum MRI score (Shahriaree Classification System - modified) at 6 month
Time frame: Six months after the last infiltration
WOMAC functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Lysholm functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Tegner Knee functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
AKS functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Lequesne functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
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VAS for pain
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Adverse event
number of patients and knees with adverse event (any); anticipated potential adverse events were infection, anaphylaxis, hematoma
Time frame: 1 year