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

NCT02958761 | Completed Phase 2

• 1 other identifier: 28914/2009
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthrosis

Keywords

knee arthrosis; platelet-derived growth factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

Biological: intraarticular injections of platelet lysate

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.

Drug: hyaluronic acid

Interventions

intraarticular injections of platelet lysate BIOLOGICAL

Platelet-rich plasma

hyaluronic acid DRUG

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

hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Claudio Lisi, MD

  Fondazione IRCCS Policlinico San Matteo di Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 29, 2016
• First Posted: November 8, 2016
• Study Start: August 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 9, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share