Treatment of Knee Arthrosis With Platelet-derived Growth Factors vs. Hyaluronic Acid.
November 8, 2016 updated by: Claudio Lisi, IRCCS Policlinico S. Matteo
Treatment of Knee Arthrosis: Platelet-derived Growth Factors vs. Hyaluronic Acid. A Phase II-III Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 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.
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ACTIVE_COMPARATOR: 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.
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intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate
Time Frame: 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
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Six months after the last infiltration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WOMAC functional scale
Time Frame: 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
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At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
|
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Lysholm functional scale
Time Frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
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multilevel generalized linear models (for panel-data) with interaction between time and treatment group
|
At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
|
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Tegner Knee functional scale
Time Frame: 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
|
At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
|
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AKS functional scale
Time Frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
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multilevel generalized linear models (for panel-data) with interaction between time and treatment group
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At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
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Lequesne functional scale
Time Frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
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multilevel generalized linear models (for panel-data) with interaction between time and treatment group
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At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
|
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VAS for pain
Time Frame: 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
|
At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
|
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Adverse event
Time Frame: 1 year
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number of patients and knees with adverse event (any); anticipated potential adverse events were infection, anaphylaxis, hematoma
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Claudio Lisi, MD, IRCCS Policlinico S. Matteo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (ACTUAL)
January 1, 2014
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
October 29, 2016
First Submitted That Met QC Criteria
November 7, 2016
First Posted (ESTIMATE)
November 8, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
November 9, 2016
Last Update Submitted That Met QC Criteria
November 8, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28914/2009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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