PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

Official title

THE USE OF FRESH PRP VS HA IN THE TREATMENT OF OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT Randomized Controlled Clinical Trial

Overview

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

Detailed description

166 patients affected by patellofemoral osteoarthritis will be included in a double-blinded RCT. In this study one group of patients will be treated with 1 intra-articular injection of PRP (treatment arm) and one group will be treated with 1 intra-articular injection of HA (control arm). Patients will be followed-up with clinical evaluation at baseline and at 2.6.12 and 24 months. Questionnaires will be administered for clinical evaluations during the follow-up visits.

Interventions

• Procedure Autologous PRP injection
  Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis
• Procedure HA injection
  Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis

Primary outcome measures

• KOOS-Pain Score [Time frame: 12 months]

Secondary outcome measures (10)

• IKDC-Subjective Score [Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up]
• KOOS-Pain Score [Time frame: baseline, 2 month, 6 months , 24 months follow-up]
• Visual Analogue Scale (VAS) [Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up]
• EQ-VAS [Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up]
• EQ-5D (EuroQoL) Current Health Assessment [Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up]
• Tegner Activity Level Scale [Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up]
• Objective parameters- Range of Motion [Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up]
• Objective parameters - Circumferences [Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up]
• Patient Acceptable Symptom State (PASS) [Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up]
• The Kujala Anterior Knee Pain Scale (AKPS) [Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Iwano score of grade 4.

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

• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT04937998 · PRP-21

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗