BridgeMD
New treatment option for Osteo Arthritis Knee
Official title Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06685120
What this study is testing
What is PRP + HA injection?
PRP + HA injection is an investigational medicine, being studied as a potential treatment for osteo arthritis knee.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- "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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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...
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.