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Compares treatment options for Patellofemoral Osteoarthritis
Official title PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT
ClinicalTrials.gov ID: NCT04937998
What this study is testing
- What it's testing
- The aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 65
You may be able to join if
- Age between 30 and 65;
- Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees;
- Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI)...
- Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC exam);
- No clinically significant electrocardiographic alterations (Recently performed ECG).
You likely can't join if
- Patients unable to express consent;
- Patients who have undergone intra-articular infiltration of another substance within the previous 6 months;
- Patients undergoing knee surgery within the previous 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with diabetes;
See the full eligibility criteria
- Age between 30 and 65;
- Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees;
- Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤ 2. [PMID: 2302884 - PMID...
- Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC exam);
- No clinically significant electrocardiographic alterations (Recently performed ECG).
- Ability and consent of patients to actively participate in clinical follow-up;
- Signature of informed consent.
- Patients unable to express consent;
- Patients who have undergone intra-articular infiltration of another substance within the previous 6 months;
- Patients undergoing knee surgery within the previous 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with hematologic diseases (coagulopathies);
- Patients on anticoagulant-antiaggregant therapy;
- Patients with 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 which a 60 mL blood draw would be contraindicated;
- Patients with a recently performed blood test with Hb\< 11 g/dl and Platelets \< 150,000 plt/mm3.
- Previous treatment of patellar dislocation
- Iwano score of grade 4.
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 30 years to 65 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.