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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: PRP infiltration

• Registration Number: NCT06483269
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-10
• Study First Submitted: 2024-06-21
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
infiltrative procedure	PRP infiltration	-

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee score	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 Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score	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.
objective parameter	baseline, 1, 3, 6, 12 months	range of motion and bilateral trans patellar and supra patellar circumferences for comparative analysis.
Tegner Activity Level Scale	baseline, 1, 3, 6, 12 months	It is a questionnaire to find out the patient's level of physical activity
Patient Acceptable Symptom State	baseline, 1, 3, 6, 12 months	Valuable tool for assessing patient satisfaction considering the patient's current degree of pain, function, and daily activity.
Expectations of treatment efficacy	baseline	The patient should indicate at baseline what benefits he or she expects from the treatment.
International Knee Documentation Committee score	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.
Visual Analogue Scale	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"
Overall judgment on treatment	baseline, 1, 3, 6, 12 months	The patient should indicate the degree of satisfaction related to the treatment performed at each follow-up.

Trial Locations

Locations (1)

IRCCS - Istituto ortopedico Rizzoli; 🇮🇹 Bologna, Italy