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RecruitingNot ApplicableNCT04937998

PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

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

Sponsor

Istituto Ortopedico Rizzoli

Enrollment

166 participants

Start Date

Oct 26, 2022

Study Type

INTERVENTIONAL

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

Eligibility

Min Age: 30 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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 Criteria16

  • 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.

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Interventions

PROCEDUREAutologous PRP injection

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

PROCEDUREHA injection

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

Locations(1)

Istituto Ortopedico Rizzoli

Bologna, Italy

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NCT04937998