PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

Patellofemoral Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937998
• Other study ID #: PRP-21
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Roberta Licciardi, MSc
• Phone: 0516366567
• Email: roberta.licciardi[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Patellofemoral Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IKDC-Subjective Score	This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function.	baseline, 2 month, 6 months, 12 months , 24 months follow-up
Secondary	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".	baseline, 2 month, 6 months , 24 months follow-up
Secondary	Visual Analogue Scale (VAS)	VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable".	baseline, 2 month, 6 months, 12 months , 24 months follow-up
Secondary	EQ-VAS	EQ-VAS Is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).	baseline, 2 month, 6 months, 12 months , 24 months follow-up
Secondary	EQ-5D (EuroQoL) Current Health Assessment	EQ-5D is useful to evaluate the quality life of the patients	baseline, 2 month, 6 months, 12 months , 24 months follow-up
Secondary	Tegner Activity Level Scale	Tegner activity level scale allows to know the level of physical activity carried out by the patients. All patients will indicate the type of sporting activity performed and its frequency.	baseline, 2 month, 6 months, 12 months , 24 months follow-up
Secondary	Objective parameters- Range of Motion	Evaluation of the Range of Motion for comparative analysis.	baseline, 2 month, 6 months, 12 months , 24 months follow-up
Secondary	Objective parameters - Circumferences	Bilateral trans- and supra- patellar circumferences measurement for comparative analysis	baseline, 2 month, 6 months, 12 months , 24 months follow-up
Secondary	Patient Acceptable Symptom State (PASS)	A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.	baseline, 2 month, 6 months, 12 months , 24 months follow-up
Secondary	The Kujala Anterior Knee Pain Scale (AKPS)	It's a 100-point scale consisting of 13 items with a score ranging from 5 to 10 points per item. A score of 0 points indicates the most severe limitation, while a score of 100 points indicates a normal situation.	baseline, 2 month, 6 months, 12 months , 24 months follow-up