Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis
Recruiting · NCT06685120 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
HA injectionPRP + HA injectionPRP injection
What this trial is about
"PRP+HA-23" is a double-blind randomized controlled clinical trial with 1:1:1 allocation. The objective of the study is to evaluate by a randomized controlled, double-blind clinical trial the efficacy and safety of viscosupplementation-associated PRP infiltration compared with PRP-only or HA-only infiltration for the treatment of patients with knee osteoarthritis.
Who can take part
Age range
40 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female patients, aged 40 to 75 years;
- Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8);
- Unilateral involvement of symptomatology;
- Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
- Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
- Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);
- Ability and consent of patients to actively participate in clinical follow-up;
- Signature of informed consent.
Exclusion criteria
- Patients unable to express consent;
- Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
- Patients undergoing knee surgery in the previous 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with uncontrolled diabetes;
- Patients with hematological diseases (coagulopathies);
- Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection;
- Patients with uncompensated thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
- Body Mass Index \> 35;
- Patients who have taken NSAIDs in the 3 days prior to blood draw;
- Patients with cardiovascular disease for whom blood sampling 30 to 60 ml would be contraindicated;
- Patients with recently performed CBC examination with Hb\< 11 g/dl and Platelet values \< 150,000 plt/mm3.
- Pregnant and/or fertile women.
Where it is running
2 locations listed.
- IRCCS Istituto Ortopedico Rizzoli - Bologna, Italy
- Istituto Ortopedico Rizzoli - Bologna, Italy