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

IRCCS Policlinico S. Matteo

Status and phase: Completed; Phase 2

Conditions: Knee Osteoarthrosis

Treatments: Drug: hyaluronic acid; Biological: intraarticular injections of platelet lysate

Study type: Interventional

Funder types: Other

Identifiers

NCT02958761

28914/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Platelet-rich plasma

Experimental group

Description:

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.

Treatment:

Biological: intraarticular injections of platelet lysate

hyaluronic acid

Active Comparator group

Description:

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.

Treatment:

Drug: hyaluronic acid