Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis

NCT06685120 | Recruiting

• 1 other identifier: PRP+HA-23
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

Brief Summary

"PRP+HA-23" is a double-blind randomized controlled clinical trial with 1:1:1 allocation. The objective of the study is to evaluate by a randomized controlled, double-blind clinical trial the efficacy and safety of viscosupplementation-associated PRP infiltration compared with PRP-only or HA-only infiltration for the treatment of patients with knee osteoarthritis.

Conditions

Osteo Arthritis Knee

Keywords

PRP; Platelet rich plasma; HA; Hyaluronic acid; PRP injection; PRP + HA injection; HA injection; Double-blind randomized controlled clinical trial

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

  12 months

Secondary Outcomes (14)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  baseline, 1,3,6 and 24 months

• IKDC-Subjective Score (Subjective International Knee Documentation Committee)

  baseline, 1,3,6, 12 and 24 months

• Objective parameters- Range of Motion

  baseline, 1,3,6, 12 and 24 months

• Objective parameters - Circumferences

  baseline, 1,3,6, 12 and 24 months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  baseline, 1,3,6, 12 and 24 months

Study Arms (3)

PRP+HA injection

EXPERIMENTAL

This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP+HA

Combination Product: PRP + HA injection

PRP injection

ACTIVE COMPARATOR

This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP

Biological: PRP injection

HA injection

ACTIVE COMPARATOR

This group of patients randomized into the treatment group, will undergo single intra-articular injection of HA

Device: HA injection

Interventions

PRP + HA injection COMBINATION_PRODUCT

Following autologous PRP harvesting and production, 5 mL of PRP and 40 mg/2 mL of HA will be infiltrated into the knee joint affected by gonarthrosis. The combined procedure will be performed by first infiltrating the hyaluronic acid, and next, leaving the needle inserted into the joint to avoid a second needle insertion, the PRP will be infiltrated, respecting the conditions of sterility. In this way, the two products will not be mixed in the same syringe.

PRP+HA injection

PRP injection BIOLOGICAL

Following autologous PRP harvesting and production, patients randomized into control group 1 will undergo single intra-articular PRP infiltration. Five mL of PRP will be infiltrated into the knee joint affected by gonarthrosis.

PRP injection

HA injection DEVICE

Patients randomized into control group 2, will undergo similar blood sampling as the PRP+ HA group and the PRP group to maintain blinding. They will then undergo intra-articular infiltration of 40 mg/ 2 ml HA into the knee with gonarthrosis.

HA injection

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, aged 40 to 75 years;
• Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8);
• Unilateral involvement of symptomatology;
• Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
• Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
• Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);
• 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 intra-articular infiltration of other substance in the previous 6 months;
• Patients undergoing knee surgery 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 at the time of blood collection;
• Patients with uncompensated 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 whom blood sampling 30 to 60 ml would be contraindicated;
• Patients with recently performed CBC examination with Hb\< 11 g/dl and Platelet values \< 150,000 plt/mm3.
• Pregnant and/or fertile women.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• University Hospital of Ferrara: collaborator

Study Sites (2)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

NOT YET RECRUITING

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (6)

• 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

• Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19.

  PMID: 32551947 BACKGROUND

• Chen WH, Lo WC, Hsu WC, Wei HJ, Liu HY, Lee CH, Tina Chen SY, Shieh YH, Williams DF, Deng WP. Synergistic anabolic actions of hyaluronic acid and platelet-rich plasma on cartilage regeneration in osteoarthritis therapy. Biomaterials. 2014 Dec;35(36):9599-607. doi: 10.1016/j.biomaterials.2014.07.058. Epub 2014 Aug 28.

  PMID: 25176059 BACKGROUND

• Chiou CS, Wu CM, Dubey NK, Lo WC, Tsai FC, Tung TDX, Hung WC, Hsu WC, Chen WH, Deng WP. Mechanistic insight into hyaluronic acid and platelet-rich plasma-mediated anti-inflammatory and anti-apoptotic activities in osteoarthritic mice. Aging (Albany NY). 2018 Dec 23;10(12):4152-4165. doi: 10.18632/aging.101713.

  PMID: 30582743 BACKGROUND

• Zhang Q, Liu T, Gu Y, Gao Y, Ni J. Efficacy and safety of platelet-rich plasma combined with hyaluronic acid versus platelet-rich plasma alone for knee osteoarthritis: a systematic review and meta-analysis. J Orthop Surg Res. 2022 Nov 19;17(1):499. doi: 10.1186/s13018-022-03398-6.

  PMID: 36403041 BACKGROUND

• Lana JF, Weglein A, Sampson SE, Vicente EF, Huber SC, Souza CV, Ambach MA, Vincent H, Urban-Paffaro A, Onodera CM, Annichino-Bizzacchi JM, Santana MH, Belangero WD. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee. J Stem Cells Regen Med. 2016 Nov 29;12(2):69-78. doi: 10.46582/jsrm.1202011. eCollection 2016.

  PMID: 28096631 BACKGROUND

Study Officials

• Davide Reale, MD

  Istituto Ortopedico Rizzoli - Argenta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide Reale, MD

CONTACT

0516366567; davide.reale@ior.it

Roberta Licciardi, MSc

CONTACT

0516366567; roberta.licciardi@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: They will be "blinded" patients, health care professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind randomized controlled clinical trial with 1:1:1 allocation

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: December 11, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

IT (2)