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

NCT ID: NCT06483269

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

infiltrative procedure

Group Type: OTHER

PRP infiltration

Intervention Type: 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.

Interventions

PRP infiltration

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS - Istituto ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mirco Lo Presti, MD

Role: CONTACT

mirco.lopresti@ior.it

0516366 ext. 084

Facility Contacts

Mirco Lo Presti, MD

Role: primary

mirco.lopresti@ior.it

0516366 ext. 084

References

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.

Reference Type: RESULT

PMID: 16921694 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12608674 (View on PubMed)

Other Identifiers

PRP-Sport Pilot

Identifier Type: -

Identifier Source: org_study_id