Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis

Official title

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

Overview

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.

Detailed description

Platelet-rich plasma (PRP) has recently emerged as an attractive biological approach to address joint degeneration. It has gained increasing attention because of the high concentration of growth factors, cytokines, and bioactive molecules stored in platelet-rich α-granules, which have been shown to participate in joint tissue homeostasis, being involved in both healing processes and immunoregulation and modulation of inflammation. Several preparation methods are available for PRP, which can give products with different compositions and characteristics.The presence of leukocytes is one of the most debated aspects of PRP efficacy, and is used as one of the main discriminators to distinguish different PRPs.

Patients with OA of the hip will be included in a randomized controlled, double-blind trial, in which one group of patients will be treated with 3 infiltrations of PRP with leukocytes and one group will be treated instead with 3 infiltrations of PRP without leukocytes. A total of 230 patients will be included and will undergo infiltrative treatment after collecting informed consent for study participation. Patients will be clinically evaluated before the injection procedure and at 2-6-12 months after treatment by the medical staff.

Interventions

• Other Leukocyte Rich- PRP injection
  Autologous Leukocyte Rich-Platelet Rich Plasma will be injected in the hip joint
• Other Leukocyte Poor- PRP injection
  Autologous Leukocyte Poor-Platelet Rich Plasma will be injected in the hip joint

Primary outcome measures

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: 6 months follow-up]

Secondary outcome measures (5)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: baseline, 2 month and 12 months]
• Visual Analogue Scale (VAS) [Time frame: baseline, 2 months, 6 months and 12 months follow-up]
• Harris Hip Scale (HHS) [Time frame: baseline, 2 months, 6 months and 12 months follow-up]
• EQ-5D (EuroQoL) Current Health Assessment [Time frame: baseline, 2 months, 6 months and 12 months follow-up]
• Patient Acceptable Symptom State (PASS) [Time frame: baseline, 2 months, 6 months and 12 months follow-up]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Istituto Ortopedico Rizzoli — Bologna

Publications

• Mobasheri A, Batt M. An update on the pathophysiology of osteoarthritis. Ann Phys Rehabil Med. 2016 Dec;59(5-6):333-339. doi: 10.1016/j.rehab.2016.07.004. Epub 2016 Aug 18. PMID 27546496
• Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19. PMID 24553908
• Fu M, Zhou H, Li Y, Jin H, Liu X. Global, regional, and national burdens of hip osteoarthritis from 1990 to 2019: estimates from the 2019 Global Burden of Disease Study. Arthritis Res Ther. 2022 Jan 3;24(1):8. doi: 10.1186/s13075-021-02705-6. PMID 34980239
• Boffa A, Salerno M, Merli G, De Girolamo L, Laver L, Magalon J, Sanchez M, Tischer T, Filardo G. Platelet-rich plasma injections induce disease-modifying effects in the treatment of osteoarthritis in animal models. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4100-4121. doi: 10.1007/s00167-021-06659-9. Epub 2021 Aug 2. PMID 34341845
• Dallari D, Stagni C, Rani N, Sabbioni G, Pelotti P, Torricelli P, Tschon M, Giavaresi G. Ultrasound-Guided Injection of Platelet-Rich Plasma and Hyaluronic Acid, Separately and in Combination, for Hip Osteoarthritis: A Randomized Controlled Study. Am J Sports Med. 2016 Mar;44(3):664-71. doi: 10.1177/0363546515620383. Epub 2016 Jan 21. PMID 26797697
• Kon E, Mandelbaum B, Buda R, Filardo G, Delcogliano M, Timoncini A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular injection versus hyaluronic acid viscosupplementation as treatments for cartilage pathology: from early degeneration to osteoarthritis. Arthroscopy. 2011 Nov;27(11):1490-501. doi: 10.1016/j.arthro.2011.05.011. Epub 2011 Aug 10. PMID 21831567
• Ornetti P, Nourissat G, Berenbaum F, Sellam J, Richette P, Chevalier X; under the aegis of the Osteoarthritis Section of the French Society for Rheumatology (Societe Francaise de Rhumatologie, SFR). Does platelet-rich plasma have a role in the treatment of osteoarthritis? Joint Bone Spine. 2016 Jan;83(1):31-6. doi: 10.1016/j.jbspin.2015.05.002. Epub 2015 Jul 7. PMID 26162636
• Battaglia M, Guaraldi F, Vannini F, Rossi G, Timoncini A, Buda R, Giannini S. Efficacy of ultrasound-guided intra-articular injections of platelet-rich plasma versus hyaluronic acid for hip osteoarthritis. Orthopedics. 2013 Dec;36(12):e1501-8. doi: 10.3928/01477447-20131120-13. PMID 24579221

Identifiers

NCT: NCT05497349 · PRP22-Hip

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗