Clinical trial NCT06685120: Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis
Official title: Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis - Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 288
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind randomized controlled clinical trial with 1:1:1 allocation
Primary purpose: TREATMENT

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.

Detailed description: Patients with osteoarthritis of the knee will be included in a randomized controlled, double-blind study, in which one group of patients will be treated with an infiltration of PRP combined with HA (PRP + HA group), one group of patients will be treated with an infiltration of PRP alone (PRP group), and another group of patients will be treated with an infiltration of HA alone (HA group). They will be "blinded" patients, health care professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data.

A total of 288 patients will be included, and they will undergo infiltrative treatment after collecting informed consent for study participation and biographical data.

All enrolled patients undergo transfusion evaluation and venous whole blood sampling from 30 to 60 mL depending on the patient's hematocrit. From the withdrawn blood, which will be collected in tubes of 9 mL each, fresh autologous PRP (PRP) will subsequently be obtained. To maintain study blinding, all patients will have their blood drawn but PRP will not be produced for patients randomized into the HA group.Following autologous PRP harvesting and production, patients randomized into the treatment group will undergo single intra-articular infiltration of PRP + HA; patients randomized into the control group 1, will undergo single intra-articular infiltration of PRP; and patients randomized into the control group 2, will undergo similar blood sampling as the PRP+ HA group and the PRP group to maintain blindness. They will then undergo an intra-articular infiltration of HA .Patients will be clinically evaluated before the infiltration procedure and at 1-3-6- 12 and 24 months after treatment by medical personnel. Questionnaires will be administered for clinical evaluations before treatment and at the above-mentioned clinical checks during follow-up

Eligibility criteria: Inclusion Criteria:

1. Male or female patients, aged 40 to 75 years;
2. Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8);
3. Unilateral involvement of symptomatology;
4. Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
5. Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
6. Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);
7. Ability and consent of patients to actively participate in clinical follow-up;
8. Signature of informed consent.

Exclusion Criteria:

1. Patients unable to express consent;
2. Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
3. Patients undergoing knee surgery in the previous 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with uncontrolled diabetes;
7. Patients with hematological diseases (coagulopathies);
8. Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection;
9. Patients with uncompensated thyroid metabolic disorders;
10. Patients abusing alcoholic beverages, drugs or medications;
11. Body Mass Index \> 35;
12. Patients who have taken NSAIDs in the 3 days prior to blood draw;
13. Patients with cardiovascular disease for whom blood sampling 30 to 60 ml would be contraindicated;
14. Patients with recently performed CBC examination with Hb\< 11 g/dl and Platelet values \< 150,000 plt/mm3.
15. Pregnant and/or fertile women.

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 12 months
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline, 1,3,6 and 24 months
measure: IKDC-Subjective Score (Subjective International Knee Documentation Committee)
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: Objective parameters- Range of Motion
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: Objective parameters - Circumferences
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: Visual Analogue Scale (VAS) (rest)
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: Visual Analogue Scale (VAS) (exercise activity)
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: EuroQol Visual Analogue Scale (EQ-VAS)
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: Tegner Activity Level Scale
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: baseline, 1,3,6, 12 and 24 months
measure: Final treatment opinion
timeFrame: 1,3,6, 12 and 24 months
measure: Effectiveness of the blinding procedure
timeFrame: baseline
measure: Expectations of treatment efficacy
timeFrame: baseline
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli - Argenta
name: Davide Reale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.