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

NCT ID: NCT02958761

Last Updated: 2016-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-07-31

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.

Conditions

Knee Osteoarthrosis

Keywords

knee arthrosis; platelet-derived growth factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet-rich plasma

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.

Group Type: EXPERIMENTAL

intraarticular injections of platelet lysate

Intervention Type: BIOLOGICAL

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.

Group Type: ACTIVE_COMPARATOR

hyaluronic acid

Intervention Type: DRUG

intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals

Interventions

intraarticular injections of platelet lysate

Intervention Type: BIOLOGICAL

hyaluronic acid

intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Claudio Lisi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudio Lisi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Policlinico San Matteo di Pavia

Other Identifiers

28914/2009

Identifier Type: -

Identifier Source: org_study_id