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

NCT05497349 | Recruiting

• 1 other identifier: PRP22-Hip
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Osteoarthritis

Keywords

PRP; LR-PRP; LP-PRP; Platelet rich plasma; PRP injection; Leukocyte Rich-PRP; Leukocyte Poor-PRP; Hip-OA; Hip Osteoarthritis; Randomized controlled trial; Injection treatment

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome

  6 months follow-up

Secondary Outcomes (5)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  baseline, 2 month and 12 months

• Visual Analogue Scale (VAS)

  baseline, 2 months, 6 months and 12 months follow-up

• Harris Hip Scale (HHS)

  baseline, 2 months, 6 months and 12 months follow-up

• EQ-5D (EuroQoL) Current Health Assessment

  baseline, 2 months, 6 months and 12 months follow-up

• Patient Acceptable Symptom State (PASS)

  baseline, 2 months, 6 months and 12 months follow-up

Study Arms (2)

Leukocyte Rich-PRP Injection

EXPERIMENTAL

Three infiltrations of Leukocyte Rich Platelet Rich Plasma 1 infiltration weekly, for 3 weeks

Other: Leukocyte Rich- PRP injection

Leukocyte Poor- PRP Injection

ACTIVE COMPARATOR

Three infiltrations of Leukocyte Poor-Platelet Rich Plasma 1 infiltration weekly, for 3 weeks.

Other: Leukocyte Poor- PRP injection

Interventions

Leukocyte Rich- PRP injection OTHER

Autologous Leukocyte Rich-Platelet Rich Plasma will be injected in the hip joint

Leukocyte Rich-PRP Injection

Leukocyte Poor- PRP injection OTHER

Autologous Leukocyte Poor-Platelet Rich Plasma will be injected in the hip joint

Leukocyte Poor- PRP Injection

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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;
• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Di Sante L, Villani C, Santilli V, Valeo M, Bologna E, Imparato L, Paoloni M, Iagnocco A. Intra-articular hyaluronic acid vs platelet-rich plasma in the treatment of hip osteoarthritis. Med Ultrason. 2016 Dec 5;18(4):463-468. doi: 10.11152/mu-874.

  PMID: 27981279 BACKGROUND

• Ye Y, Zhou X, Mao S, Zhang J, Lin B. Platelet rich plasma versus hyaluronic acid in patients with hip osteoarthritis: A meta-analysis of randomized controlled trials. Int J Surg. 2018 May;53:279-287. doi: 10.1016/j.ijsu.2018.03.078. Epub 2018 Apr 5.

  PMID: 29626641 BACKGROUND

• Di Martino A, Boffa A, Andriolo L, Romandini I, Altamura SA, Cenacchi A, Roverini V, Zaffagnini S, Filardo G. Leukocyte-Rich versus Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Trial. Am J Sports Med. 2022 Mar;50(3):609-617. doi: 10.1177/03635465211064303. Epub 2022 Feb 1.

  PMID: 35103547 BACKGROUND

• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

  PMID: 3068365 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dante Dallari, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dante Dallari, MD

CONTACT

6366318; dante.dallari@ior.it

Roberta Licciardi, MSc

CONTACT

6366567; roberta.licciardi@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind randomized controlled trial with allocation 1:1. Patient blinding will be provided during the injection treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a double-blinded RCT in which one group of patients will be treated with 3 intra-articular injection of Leukocyte Rich-PRP, and one group will be treated with 3 intra-articular injection of Leukocyte Poor- PRP

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: October 5, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

IT (1)