About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

166 Participants

are divided into 2 treatment groups

Group A: Autologous PRP injectionExperimental treatment 1 intervention

Group B: HA injectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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".

Time frame

12 months

Secondary outcomes

1

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.

Time frame

baseline, 2 month, 6 months, 12 months , 24 months follow-up

2

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".

Time frame

baseline, 2 month, 6 months , 24 months follow-up

3

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".

Time frame

baseline, 2 month, 6 months, 12 months , 24 months follow-up

4

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).

Time frame

baseline, 2 month, 6 months, 12 months , 24 months follow-up

PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts