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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Knee Osteoarthrosis

Intervention / Treatment
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* Biological: intraarticular injections of platelet lysate
* Drug: hyaluronic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-rich plasma<br>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. | Biological: intraarticular injections of platelet lysate<br> <br> |
| Active Comparator: hyaluronic acid<br>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. | Drug: hyaluronic acid<br>* intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Six months after the last infiltration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC functional scale | 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 | 
| Lysholm functional scale | 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 | 
| Tegner Knee functional scale | 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 | 
| AKS functional scale | 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 | 
| Lequesne functional scale | 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 | 
| VAS for pain | 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 | 
| Adverse event | number of patients and knees with adverse event (any); anticipated potential adverse events were infection, anaphylaxis, hematoma | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee arthrosis, platelet-derived growth factors