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NCT Number: NCT06483269

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS - Istituto ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Mirco Lo Presti, MD

CONTACT

[email protected]

0516366 ext. 084

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. International Knee Documentation Committee score

    Time frame: 6 months

    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.

Secondary outcomes

  1. International Knee Documentation Committee score

    Time frame: baseline, 1, 3, 6, 12 months

    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.

  2. Tegner Activity Level Scale

    Time frame: baseline, 1, 3, 6, 12 months

    It is a questionnaire to find out the patient's level of physical activity

  3. Knee Injury and Osteoarthritis Outcome Score

    Time frame: baseline, 1, 3, 6, 12 months

    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.

  4. Visual Analogue Scale

    Time frame: baseline, 1, 3, 6, 12 months

    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"

  5. objective parameter

    Time frame: baseline, 1, 3, 6, 12 months

    range of motion and bilateral trans patellar and supra patellar circumferences for comparative analysis.

  6. Patient Acceptable Symptom State

    Time frame: baseline, 1, 3, 6, 12 months

    Valuable tool for assessing patient satisfaction considering the patient's current degree of pain, function, and daily activity.

  7. Expectations of treatment efficacy

    Time frame: baseline

    The patient should indicate at baseline what benefits he or she expects from the treatment.

  8. Overall judgment on treatment

    Time frame: baseline, 1, 3, 6, 12 months

    The patient should indicate the degree of satisfaction related to the treatment performed at each follow-up.

Other outcomes

  1. Tolerability assessment parameters:

    Time frame: baseline, 1, 3, 6, 12 months

    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.

  2. Platelet-rich plasma-Homologous (PRP-O) evaluation parameters

    Time frame: baseline, 1, 3, 6, 12 months

    The quality of the administered Platelet-rich plasma- Homologous (PRP-O) will be assested by using standard blood parameters data as hematological control.

Study contacts

Contact information is provided by the study sponsor or research team.

Mirco Lo Presti, MD

CONTACT

[email protected]

0516366 ext. 084

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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