PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

Not Applicable

Recruiting

• Conditions: Patellofemoral Osteoarthritis
• Interventions: Procedure: HA injection; Procedure: Autologous PRP injection

• Registration Number: NCT04937998
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-24
• Study Start: 2022-10-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 166

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA injection	HA injection	This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA)
Autologous PRP injection	Autologous PRP injection	This group of patients will be treated with single intra-articular injection of Autologous PRP.

Primary Outcome Measures

Name	Time	Method
KOOS-Pain Score	12 months	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".

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	baseline, 2 month, 6 months, 12 months , 24 months follow-up	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".
EQ-VAS	baseline, 2 month, 6 months, 12 months , 24 months follow-up	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).
KOOS-Pain Score	baseline, 2 month, 6 months , 24 months follow-up	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".
EQ-5D (EuroQoL) Current Health Assessment	baseline, 2 month, 6 months, 12 months , 24 months follow-up	EQ-5D is useful to evaluate the quality life of the patients
Tegner Activity Level Scale	baseline, 2 month, 6 months, 12 months , 24 months follow-up	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.
Objective parameters- Range of Motion	baseline, 2 month, 6 months, 12 months , 24 months follow-up	Evaluation of the Range of Motion for comparative analysis.
Objective parameters - Circumferences	baseline, 2 month, 6 months, 12 months , 24 months follow-up	Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
IKDC-Subjective Score	baseline, 2 month, 6 months, 12 months , 24 months follow-up	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.
Patient Acceptable Symptom State (PASS)	baseline, 2 month, 6 months, 12 months , 24 months follow-up	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.
The Kujala Anterior Knee Pain Scale (AKPS)	baseline, 2 month, 6 months, 12 months , 24 months follow-up	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy