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New treatment option for Hip Osteoarthritis
Official title Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis
ClinicalTrials.gov ID: NCT05497349
What this study is testing
- What it's testing
- The aim of the study is to compare the efficacy up to 12 months of two different types of PRP (PRP with leukocytes vs PRP depleted of leukocytes) in the echo-guided infiltrative treatment of hip OA by including 230 patients in the study and evaluating them through subjective (using the WOMAC score as the primary outcome) and objective clinical scores.
- 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 35 to 70
You may be able to join if
- Signs and symptoms of hip OA (pain intensity of at least 4 points and not more than 8 of VAS pain - 0-10 scale in the previous week);
- Radiographic signs of hip OA (Grade 1-2 according to Tonnis classification) or MRI signs (chondropathy or minimal labrum degeneration without acute...
- Unilateral involvement; Hemoglobin \> 11 g/dl;
- Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);
- Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
You likely can't join if
- Patients unable to express consent;
- Patients undergoing infiltration of other substance in the previous 6 months;
- Patients undergoing lower limb surgery to be treated 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 for at least 3 days prior to blood collection;
See the full eligibility criteria
- Signs and symptoms of hip OA (pain intensity of at least 4 points and not more than 8 of VAS pain - 0-10 scale in the previous week);
- Radiographic signs of hip OA (Grade 1-2 according to Tonnis classification) or MRI signs (chondropathy or minimal labrum degeneration without acute lesions) even if Grade 0.
- Unilateral involvement; Hemoglobin \> 11 g/dl;
- Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);
- Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- No clinically significant electrocardiographic changes (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 undergoing infiltration of other substance in the previous 6 months;
- Patients undergoing lower limb surgery to be treated 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 for at least 3 days prior to blood collection;
- Patients with uncontrolled thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
- Body Mass Index \> 30;
- Patients who have taken NSAIDs in the 3 days prior to blood draw;
- Patients with cardiovascular disease for whom 300 ml blood draw would be contraindicated;
- Patients with recently performed CBC examination with Hb\< 11 g/dl and Platelet values \< 150,000 plt/mm3.
- Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- Pregnant and/or fertile women.
- Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale.
- Patients with other hip pathologies: acetabular protrusion, concentric migration of the femoral head, presence of excessive deformity resulting from acetabular or femoral head dysplasia, collapse deformity, and deformed...
- Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).
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, 35 years to 70 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.