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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 August 2021 |
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Main ID: |
NCT02923700 |
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Date of registration:
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30/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
PRP014 |
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Scientific title:
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Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial |
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Date of first enrolment:
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September 26, 2016 |
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Target sample size:
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192 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02923700 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Elizaveta Kon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy |
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Name:
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Alessandro Di Martino, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy |
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Name:
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Alice Roffi, BA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rizzoli Orthopaedic Institute, Bologna, Italy |
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Name:
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Berardo Di Matteo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy |
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Name:
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Francesco Tentoni, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. patients affected by mono-lateral symptomatic knee articular degenerative pathology
with history of chronic (for at least 4 months) pain or swelling;
2. imaging findings of degenerative changes of the joint (osteoarthritis or chondropathy
with Kellgren Lawrence Score from 0 to 3 at X-ray evaluation).
Exclusion Criteria:
- age > 80 years;
- Kellgren-Lawrence score at X-ray evaluation > 3;
- major axial deviation (varus >5° , valgus > 5°),
- systemic disorders such as diabetes, rheumatoid arthritis, haematological diseases
(coagulopathy), severe cardiovascular diseases, infections, immunodepression;
- patients in therapy with anticoagulants or antiaggregants;
- use of NSAIDs in the 5 days before blood donation;
- patients with Hb values < 11 g/dl and platelet values < 150,000/mmc.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Biological: Leukocyte-rich PRP intra-articular injections
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Biological: Leukocyte-poor PRP intra-articular injections
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Primary Outcome(s)
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IKDC (International knee documentation committee) score trend over time
[Time Frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment]
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Secondary Outcome(s)
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KOOS (Knee Outcome Osteoarthritis Score) trend over time
[Time Frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment]
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VAS (Visual Analogue Scale) for Pain trend over time
[Time Frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment]
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Tegner Score trend over time
[Time Frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment]
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Adverse events report during follow-up period
[Time Frame: ba1 month, 2 months, 6 months and 12 months after treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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