PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

NCT04937998 | Recruiting

• 1 other identifier: PRP-21
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA

Conditions

Patellofemoral Osteoarthritis

Keywords

PRP; HA; Osteoarthritis; Autologous PRP; PRP injection; HA injection; injection treatment; Randomized controlled trial; Hyaluronic Acid; Platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• KOOS-Pain Score

  KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain".

  12 months

Secondary Outcomes (10)

• IKDC-Subjective Score

  baseline, 2 month, 6 months, 12 months , 24 months follow-up

• KOOS-Pain Score

  baseline, 2 month, 6 months , 24 months follow-up

• Visual Analogue Scale (VAS)

  baseline, 2 month, 6 months, 12 months , 24 months follow-up

• EQ-VAS

  baseline, 2 month, 6 months, 12 months , 24 months follow-up

• EQ-5D (EuroQoL) Current Health Assessment

  baseline, 2 month, 6 months, 12 months , 24 months follow-up

Study Arms (2)

Autologous PRP injection

EXPERIMENTAL

This group of patients will be treated with single intra-articular injection of Autologous PRP.

Procedure: Autologous PRP injection

HA injection

ACTIVE COMPARATOR

This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA)

Procedure: HA injection

Interventions

Autologous PRP injection PROCEDURE

Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis

Autologous PRP injection

HA injection PROCEDURE

Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis

HA injection

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 30 and 65;
• Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees;
• Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤ 2. \[PMID: 2302884 - PMID: 27979409\] ;
• Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC exam);
• No clinically significant electrocardiographic alterations (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 who have undergone intra-articular infiltration of another substance within the previous 6 months;
• Patients undergoing knee surgery within the previous 12 months;
• Patients with malignant neoplasms;
• Patients with rheumatic diseases;
• Patients with diabetes;
• Patients with hematologic diseases (coagulopathies);
• Patients on anticoagulant-antiaggregant therapy;
• Patients with 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 which a 60 mL blood draw would be contraindicated;
• Patients with a recently performed blood test with Hb\< 11 g/dl and Platelets \< 150,000 plt/mm3.
• Previous treatment of patellar dislocation

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

Related Publications (5)

• Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.

  PMID: 30545242 BACKGROUND

• Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87.

  PMID: 16921694 BACKGROUND

• Cavallo C, Filardo G, Mariani E, Kon E, Marcacci M, Pereira Ruiz MT, Facchini A, Grigolo B. Comparison of platelet-rich plasma formulations for cartilage healing: an in vitro study. J Bone Joint Surg Am. 2014 Mar 5;96(5):423-9. doi: 10.2106/JBJS.M.00726.

  PMID: 24599205 BACKGROUND

• deDeugd CM, Pareek A, Krych AJ, Cummings NM, Dahm DL. Outcomes of Patellofemoral Arthroplasty Based on Radiographic Severity. J Arthroplasty. 2017 Apr;32(4):1137-1142. doi: 10.1016/j.arth.2016.11.006. Epub 2016 Nov 15.

  PMID: 27979409 BACKGROUND

• Assirelli E, Filardo G, Mariani E, Kon E, Roffi A, Vaccaro F, Marcacci M, Facchini A, Pulsatelli L. Effect of two different preparations of platelet-rich plasma on synoviocytes. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2690-703. doi: 10.1007/s00167-014-3113-3. Epub 2014 Jun 19.

  PMID: 24942296 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alessandro Di Martino, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Licciardi, MSc

CONTACT

0516366567; roberta.licciardi@ior.it

Alessandro Di Martino, MD

CONTACT

alessandro.dimartino@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-blinded randomized controlled trial with 1:1 allocation.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 1 intra-articular injection of fresh PRP, and one group will be treated with 1 intra-articular injection of HA.

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 24, 2021
• Study Start: October 26, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)