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Clinical Trials in Italy / NCT04901273
Recruiting Not applicable

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

NCT04901273 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Not applicable
Started
2021-12-15
Last updated
2025-08-03

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

Homologous PRP injectionsPlacebo injection (saline solution)

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

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

Study 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Unilateral involvement; 2. Signs and symptoms of degenerative pathology of the knee cartilage; 3. Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades); 4. Ability and consent of patients to actively participate in clinical follow-up; 5. Signature of informed consent Exclusion Criteria: 1. Patients undergoing knee surgery within the previous 12 months; 2. Patients with malignant neoplasms; 3. Patients with rheumatic diseases; 4. Patients with diabetes; 5. Patients with hematologic diseases (coagulopathies); 6. Patients with metabolic disorders of the thyroid gland; 7. Patients abusing alcoholic beverages, drugs or medications 8. Body Mass Index \> 35

Primary outcome measure(s)

  • KOOS-Pain Score — 6 months FU
    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".

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italy Recruiting

More Istituto Ortopedico Rizzoli trials in Italy

Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement Recruiting
Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design Recruiting
Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis Recruiting
Identification of Circulating Biomarkers Associated With Extracellular Vesicles in Sarcomas Recruiting
Prospective Observational Cohort Study of Cardiac Structure and Function in Children and Adults With Osteogenesis Imperfecta Recruiting

Other trials for the same condition

Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement Recruiting
Crosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System Recruiting
Long Term Evaluation of Clinical and Radiologic Results on Femoro-patellar Joint After High Tibial Osteotomy Recruiting
Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis Recruiting
An Artificial Intelligence-based Approach in Total Knee Arthroplasty: From Inflammatory Responses to Personalized Medicine Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04901273 on ClinicalTrials.gov ↗ ← All trials in Italy