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Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients

I

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Knee Osteoarthritis

Treatments

Procedure: PRP infiltration

Study type

Interventional

Funder types

Other

Identifiers

NCT06483269
PRP-Sport Pilot

Details and patient eligibility

About

The study consists of 3 phases (enrollment, infiltrative procedure, and controls):

  • Identification by specialized orthopedic medical staff belonging to the SC Orthopedic and Trauma Clinic II of the Rizzoli Orthopedic Institute of subjects who meet the study inclusion criteria. Signing of informed consent form and completion of evaluation questionnaires.
  • infiltrative procedure
  • Patients will be clinically evaluated before the infiltration procedure and at 1, 3, 6, and 12 months after treatment by trained medical personnel (outcome assessors). Questionnaires will be administered for clinical evaluations before treatment and at these clinical checkups during follow-up. Any adverse events to treatment will also be assessed during follow-up visits. The duration and extent of joint swelling and pain following infiltration will be reported, and any drug therapies taken by the patient will be recorded.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients, both sexes, with symptomatic knee osteoarthritis with:
  • Age: 18-40 years;
  • Unilateral involvement;
  • Signs and symptoms of knee osteoarthritis;
  • Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
  • Ability and consent of patients to actively participate in clinical follow-up;
  • Signature of informed consent;
  • Pain ≥ 4 on VAS s

Exclusion criteria

  • Patients unable to express consent;
  • Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
  • Patients undergoing knee surgery in the previous 12 months;
  • Patients with malignant neoplasms;
  • Patients with rheumatic diseases;
  • Patients with uncontrolled metabolic diseases;
  • Patients with hematological diseases (coagulopathies);
  • Patients abusing alcoholic beverages, drugs or medications;
  • Knee trauma treated in the previous 6 months.
  • Other conditions that may interfere with the evaluation of OA treatment.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

infiltrative procedure
Other group
Treatment:
Procedure: PRP infiltration

Trial contacts and locations

1

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Central trial contact

Mirco Lo Presti, MD

Data sourced from clinicaltrials.gov

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