- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04852380
Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis
Clinical Results Of Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis (KOA), Our Experience At Midterm Follow Up
It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bari, Italy, 70124
- AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 40 and 81;
- Body mass index (BMI) between 21.5 and 29.3;
- Chronic history (for at least 4 months) of knee joint pain;
- Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)
Exclusion Criteria:
- Radiographically severe documented knee osteoarthritis of grade 4 (K-L radiographic classification scale);
- Previous femur and tibia fractures;
- Knee previous surgical treatment (e.g., arthroscopy);
- Hyaluronic acid infiltration within the previous six months;
- Hemoglobin levels <10 g/dL;
- History of oncohematological disease, infections, or immunodepression
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients treated by PRP injection
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The 5 mL PRP concentrate was injected every week for three times, starting from recruitment.
The patient was placed supine whit a knee flexion of 90°.All the procedures were carried out in an aseptic condition, injected in the knee soft spot through an anterior approach, using a 21-gauge needle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Analogic Scale
Time Frame: Day 0; Month 1; Month 3; Month 6 (after the injection)
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The knee pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
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Day 0; Month 1; Month 3; Month 6 (after the injection)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRP-Knee Osteoarthritis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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