Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-27 @ 8:36 AM
Study NCT ID:
NCT02958761
Status:
COMPLETED
Last Update Posted:
2016-11-09
First Post:
2016-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Knee Arthrosis With Platelet-derived Growth Factors vs. Hyaluronic Acid.
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Study Overview
Official Title:
Treatment of Knee Arthrosis: Platelet-derived Growth Factors vs. Hyaluronic Acid. A Phase II-III Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: