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Recruiting NCT06483269

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

No phase Interventional Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRP infiltration.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 r

Primary outcome measures

  • International Knee Documentation Committee score [Time frame: 6 months]
Secondary outcome measures (8)
  • International Knee Documentation Committee score [Time frame: baseline, 1, 3, 6, 12 months]
  • Tegner Activity Level Scale [Time frame: baseline, 1, 3, 6, 12 months]
  • Knee Injury and Osteoarthritis Outcome Score [Time frame: baseline, 1, 3, 6, 12 months]
  • Visual Analogue Scale [Time frame: baseline, 1, 3, 6, 12 months]
  • objective parameter [Time frame: baseline, 1, 3, 6, 12 months]
  • Patient Acceptable Symptom State [Time frame: baseline, 1, 3, 6, 12 months]
  • Expectations of treatment efficacy [Time frame: baseline]
  • Overall judgment on treatment [Time frame: baseline, 1, 3, 6, 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • IRCCS - Istituto ortopedico Rizzoli — Bologna

Publications

  • 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
  • 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

Identifiers

NCT: NCT06483269 · PRP-Sport Pilot

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗