RecruitingNot ApplicableNCT04901273

Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients

Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

204 participants

Start Date

Dec 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.


Eligibility

Min Age: 65 Years

Inclusion Criteria5

  • Unilateral involvement;
  • Signs and symptoms of degenerative pathology of the knee cartilage;
  • Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
  • Ability and consent of patients to actively participate in clinical follow-up;
  • Signature of informed consent

Exclusion Criteria8

  • 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 with metabolic disorders of the thyroid gland;
  • Patients abusing alcoholic beverages, drugs or medications
  • Body Mass Index > 35

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Interventions

PROCEDUREHomologous PRP injections

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

PROCEDUREPlacebo injection (saline solution)

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


Locations(1)

Istituto Ortopedico Rizzoli

Bologna, Italy

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NCT04901273


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