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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich plasma | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraarticular injections of platelet lysate | Biological |
| ||
| hyaluronic acid |
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Lisi, MD | Fondazione IRCCS Policlinico San Matteo di Pavia | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 6, 2016 | |
| Reset | Jan 31, 2017 | |
| Release | Mar 28, 2017 | |
| Reset | May 8, 2017 | |
| Release | Mar 6, 2018 | |
| Reset | Apr 4, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 6, 2016 | Jan 31, 2017 | |||
| Mar 28, 2017 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Drug |
intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals |
|
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 |
| May 8, 2017 |
| Mar 6, 2018 | Apr 4, 2018 |
| D012216 |
| Rheumatic Diseases |