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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04937998
Other study ID # PRP-21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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