PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04937998

Collaborator

(none)

166

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Patellofemoral Osteoarthritis	Procedure: Autologous PRP injection Procedure: HA injection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

This is a double-blinded randomized controlled trial with 1:1 allocation.Patient blinding will be provided during the injection treatment.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Autologous PRP injection This group of patients will be treated with single intra-articular injection of Autologous PRP.	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
Active Comparator: HA injection This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA)	Procedure: HA injection Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis

Arm

Intervention/Treatment

Experimental: Autologous PRP injection

This group of patients will be treated with single intra-articular injection of Autologous PRP.

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

Active Comparator: HA injection

This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA)

Procedure: HA injection

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

Outcome Measures

Primary Outcome Measures

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

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.
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".
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).
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.