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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: PRP infiltration

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mirco Lo Presti, MD; Phone Number: 084 0516366; Email: mirco.lopresti@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • IRCCS - Istituto Ortopedico Rizzoli
    • Contact: Mirco Lo Presti, MD; Phone Number: 084 0516366; Email: mirco.lopresti@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: infiltrative procedure

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 1, 3, 6, 12 months
Tegner Activity Level Scale	It is a questionnaire to find out the patient's level of physical activity	baseline, 1, 3, 6, 12 months
Knee Injury and Osteoarthritis Outcome Score	The full questionnaire consists of five subscales and they cover: pain (9 items), symptoms (7 items of which two relate to stiffness), functions and activities of daily living (17 items) physical function, sports activities and leisure (5 items) and quality of life in relation to the knee (4 items). All items in the relevant subscales have the same response mode, use a 5-point Likert scale, and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "a severe difficulty). Score range 0-100 for each subscale.	baseline, 1, 3, 6, 12 months
Visual Analogue Scale	visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable"	baseline, 1, 3, 6, 12 months
objective parameter	range of motion and bilateral trans patellar and supra patellar circumferences for comparative analysis.	baseline, 1, 3, 6, 12 months
Patient Acceptable Symptom State	Valuable tool for assessing patient satisfaction considering the patient's current degree of pain, function, and daily activity.	baseline, 1, 3, 6, 12 months
Expectations of treatment efficacy	The patient should indicate at baseline what benefits he or she expects from the treatment.	baseline
Overall judgment on treatment	The patient should indicate the degree of satisfaction related to the treatment performed at each follow-up.	baseline, 1, 3, 6, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability assessment parameters:	All adverse events will be reported by filling out "Adverse event report forms" that will be kept with each patient's CRF (Case Report Form). The latter will document all medications taken additionally by the patient for pain control, indicating brand name, generic name, start and end of intake, and daily dose. Serious adverse events will be reported as per company procedure and the Ethics Committee will be informed, which will rule on whether patient enrollment should be discontinued.	baseline, 1, 3, 6, 12 months
Platelet-rich plasma-Homologous (PRP-O) evaluation parameters	The quality of the administered Platelet-rich plasma- Homologous (PRP-O) will be assested by using standard blood parameters data as hematological control.	baseline, 1, 3, 6, 12 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PRP-Sport Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No