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

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

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.

Patients in the intervention group will receive three autologous PRP plus calcium gluconate (as activator) intraarticular injections at 4-week intervals. Briefly, at the Immunohaematology and Transfusion Service, on each scheduled visit 20 ml of autologous whole blood will be sampled from each patient, 2 ml ACD-A will be added directly the syringe as anticoagulant; finally the vial will be gently centrifuged at 900rpm for 7 minutes. Platelet-rich plasma was collected. The PRP vials plus activator will be immediately shipped to the rehabilitation unit, where intraarticular injection will be performed by an experienced physiatrist.

Patients in the control group will receive three intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals, by the same study staff.

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

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

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

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

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

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

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

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

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

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.