Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04937998

PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Patellofemoral Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous PRP injection

Procedure

Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis

HA injection

Procedure

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

Primary outcomes

  1. KOOS-Pain Score

    Time frame: 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 outcomes

  1. IKDC-Subjective Score

    Time frame: 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.

  2. KOOS-Pain Score

    Time frame: 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".

  3. Visual Analogue Scale (VAS)

    Time frame: 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".

  4. EQ-VAS

    Time frame: 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).

  5. EQ-5D (EuroQoL) Current Health Assessment

    Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up

    EQ-5D is useful to evaluate the quality life of the patients

  6. Tegner Activity Level Scale

    Time frame: 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.

  7. Objective parameters- Range of Motion

    Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up

    Evaluation of the Range of Motion for comparative analysis.

  8. Objective parameters - Circumferences

    Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up

    Bilateral trans- and supra- patellar circumferences measurement for comparative analysis

  9. Patient Acceptable Symptom State (PASS)

    Time frame: 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.

  10. The Kujala Anterior Knee Pain Scale (AKPS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Di Martino, MD

CONTACT

[email protected]

Roberta Licciardi, MSc

CONTACT

[email protected]

0516366567

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2021
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.