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

NCT06483269 | Recruiting

• 1 other identifier: PRP-Sport Pilot
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• International Knee Documentation Committee score

  This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function.

  6 months

Secondary Outcomes (8)

• International Knee Documentation Committee score

  baseline, 1, 3, 6, 12 months

• Tegner Activity Level Scale

  baseline, 1, 3, 6, 12 months

• Knee Injury and Osteoarthritis Outcome Score

  baseline, 1, 3, 6, 12 months

• Visual Analogue Scale

  baseline, 1, 3, 6, 12 months

• objective parameter

  baseline, 1, 3, 6, 12 months

Other Outcomes (2)

• Tolerability assessment parameters:

  baseline, 1, 3, 6, 12 months

• Platelet-rich plasma-Homologous (PRP-O) evaluation parameters

  baseline, 1, 3, 6, 12 months

Study Arms (1)

infiltrative procedure

OTHER

Procedure: PRP infiltration

Interventions

PRP infiltration PROCEDURE

a single intra-articular infiltration of 5 mL of PRP-O will be performed by the infiltrating physician. It is specified that the PRP-O used within the study will be produced following the guidelines and standards for the production of blood products for non-transfusion use as already in place at the Unified Metropolitan Transfusion Service IOR site. PRP (Platelet Rich Plasma) is produced from platelet pool from donor buffy coat. PRP contains 1,000,000 PLT/mml +/- 20%, as required by current regulations.

infiltrative procedure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS - Istituto ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (2)

• Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87.

  PMID: 16921694 RESULT

• Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma the perfect enhancement factor? A current review. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):93-103.

  PMID: 12608674 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Mirco Lo Presti, MD

CONTACT

0516366; mirco.lopresti@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 3, 2024
• Study Start: October 10, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

IT (1)