Clinical trial NCT06483269: Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients
Official title: Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: International Knee Documentation Committee score
timeFrame: 6 months
Secondary outcomes:
measure: International Knee Documentation Committee score
timeFrame: baseline, 1, 3, 6, 12 months
measure: Tegner Activity Level Scale
timeFrame: baseline, 1, 3, 6, 12 months
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: baseline, 1, 3, 6, 12 months
measure: Visual Analogue Scale
timeFrame: baseline, 1, 3, 6, 12 months
measure: objective parameter
timeFrame: baseline, 1, 3, 6, 12 months
measure: Patient Acceptable Symptom State
timeFrame: baseline, 1, 3, 6, 12 months
measure: Expectations of treatment efficacy
timeFrame: baseline
measure: Overall judgment on treatment
timeFrame: baseline, 1, 3, 6, 12 months
Other outcomes:
measure: Tolerability assessment parameters:
timeFrame: baseline, 1, 3, 6, 12 months
measure: Platelet-rich plasma-Homologous (PRP-O) evaluation parameters
timeFrame: baseline, 1, 3, 6, 12 months
Locations:
city: Bologna
country: Italy
facility: IRCCS - Istituto ortopedico Rizzoli
Study officials:
References:
citation: 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.
citation: 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.