Comparing two types of PRP injections for hip osteoarthritis treatment

Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis. Double-blind Controlled Randomized Clinical Trial

This study is testing whether two different types of PRP injections can help people with hip osteoarthritis feel better over a year.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 35 Years to 70 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Locations: 1 site (Bologna)
• Trial ID: NCT05497349 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of leukocyte-rich platelet-rich plasma (LR-PRP) versus leukocyte-free platelet-rich plasma (LP-PRP) in treating hip osteoarthritis over a 12-month period. A total of 230 patients with hip OA will be randomly assigned to receive either LR-PRP or LP-PRP injections, with three infiltrations administered. The primary outcome will be assessed using the WOMAC score, along with other clinical evaluations conducted at 2, 6, and 12 months post-treatment. The study will help clarify the role of leukocytes in PRP efficacy for joint health.

Who should consider this trial

Good fit: Ideal candidates are individuals with unilateral hip osteoarthritis showing specific pain and radiographic signs.

Not a fit: Patients with significant comorbidities or those who have undergone recent joint surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from hip osteoarthritis.

How similar studies have performed: Previous studies have shown varying results regarding the efficacy of different PRP preparations, making this approach both relevant and necessary for further investigation.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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 femoral head sequelae of Perthes disease or osteonecrosis of the femoral head.
* Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).

Where this trial is running

Bologna

• Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)

Study contacts

• Principal investigator: Dante Dallari, MD — Istituto Ortopedico Rizzoli
• Study coordinator: Dante Dallari, MD

Conditions Hip Osteoarthritis; PRP; LR-PRP; LP-PRP; Platelet rich plasma; PRP injection; Leukocyte Rich-PRP; Leukocyte Poor-PRP