Treatment of Knee Arthrosis With Platelet-derived Growth Factors vs. Hyaluronic Acid.
- Conditions
- Knee Osteoarthrosis
- Interventions
- Biological: intraarticular injections of platelet lysate
- Registration Number
- NCT02958761
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Platelet-rich plasma intraarticular injections of platelet lysate 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. hyaluronic acid hyaluronic acid 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.
- Primary Outcome Measures
Name Time Method Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate 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 Outcome Measures
Name Time Method Adverse event 1 year number of patients and knees with adverse event (any); anticipated potential adverse events were infection, anaphylaxis, hematoma
Lysholm functional scale 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
Lequesne functional scale 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
VAS for pain 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
AKS functional scale 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
WOMAC functional scale 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
Tegner Knee functional scale 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