Knee Osteoarthrosis
Conditions
Keywords
knee arthrosis, platelet-derived growth factors
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.
Interventions
BIOLOGICALintraarticular injections of platelet lysate
DRUGhyaluronic acid
intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate | Six months after the last infiltration | Each knee was improvement, from baseline, by at least one degree the maximum MRI score (Shahriaree Classification System - modified) at 6 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | multilevel generalized linear models (for panel-data) with interaction between time and treatment group |
| 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 | multilevel generalized linear models (for panel-data) with interaction between time and treatment group |
| 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 | multilevel generalized linear models (for panel-data) with interaction between time and treatment group |
| 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 | multilevel generalized linear models (for panel-data) with interaction between time and treatment group |
| VAS for pain | At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year | multilevel generalized linear models (for panel-data) with interaction between time and treatment group |
| Adverse event | 1 year | number of patients and knees with adverse event (any); anticipated potential adverse events were infection, anaphylaxis, hematoma |
| 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 | multilevel generalized linear models (for panel-data) with interaction between time and treatment group |
Outcome results
None listed