Clinical trial NCT02958761: Treatment of Knee Arthrosis With Platelet-derived Growth Factors vs. Hyaluronic Acid.
Official title: Treatment of Knee Arthrosis: Platelet-derived Growth Factors vs. Hyaluronic Acid. A Phase II-III Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthrosis
Keywords: knee arthrosis
platelet-derived growth factors
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate
timeFrame: Six months after the last infiltration
Secondary outcomes:
measure: WOMAC functional scale
timeFrame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
measure: Lysholm functional scale
timeFrame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
measure: Tegner Knee functional scale
timeFrame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
measure: AKS functional scale
timeFrame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
measure: Lequesne functional scale
timeFrame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
measure: VAS for pain
timeFrame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
measure: Adverse event
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Claudio Lisi, MD
role: PRINCIPAL_INVESTIGATOR
References: