Clinical trial NCT04937998: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellofemoral Osteoarthritis
Keywords: PRP
HA
Osteoarthritis
Autologous PRP
PRP injection
HA injection
injection treatment
Randomized controlled trial
Hyaluronic Acid
Platelet rich plasma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 166
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

1. Age between 30 and 65;
2. Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees;
3. 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. \[PMID: 2302884 - PMID: 27979409\] ;
4. Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC exam);
5. No clinically significant electrocardiographic alterations (Recently performed ECG).
6. Ability and consent of patients to actively participate in clinical follow-up;
7. Signature of informed consent.

Exclusion Criteria:

1. Patients unable to express consent;
2. Patients who have undergone intra-articular infiltration of another substance within the previous 6 months;
3. Patients undergoing knee surgery within the previous 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with diabetes;
7. Patients with hematologic diseases (coagulopathies);
8. Patients on anticoagulant-antiaggregant therapy;
9. Patients with 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 which a 60 mL blood draw would be contraindicated;
14. Patients with a recently performed blood test with Hb\< 11 g/dl and Platelets \< 150,000 plt/mm3.
15. Previous treatment of patellar dislocation
16. Iwano score of grade 4.

Primary outcomes:
measure: KOOS-Pain Score
timeFrame: 12 months
Secondary outcomes:
measure: IKDC-Subjective Score
timeFrame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
measure: KOOS-Pain Score
timeFrame: baseline, 2 month, 6 months , 24 months follow-up
measure: Visual Analogue Scale (VAS)
timeFrame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
measure: EQ-VAS
timeFrame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
measure: Tegner Activity Level Scale
timeFrame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
measure: Objective parameters- Range of Motion
timeFrame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
measure: Objective parameters - Circumferences
timeFrame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
measure: Patient Acceptable Symptom State (PASS)
timeFrame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
measure: The Kujala Anterior Knee Pain Scale (AKPS)
timeFrame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Alessandro Di Martino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.