NCT06483269RecruitingNot Applicable
Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients
Istituto Ortopedico Rizzoli1 site in 1 country30 target enrollmentStarted: October 10, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- International Knee Documentation Committee score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
infiltrative procedure
Other
Intervention: PRP infiltration (Procedure)
Outcomes
Primary Outcomes
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
- Knee Injury and Osteoarthritis Outcome Score(baseline, 1, 3, 6, 12 months)
- objective parameter(baseline, 1, 3, 6, 12 months)
- Tegner Activity Level Scale(baseline, 1, 3, 6, 12 months)
- Patient Acceptable Symptom State(baseline, 1, 3, 6, 12 months)
- Expectations of treatment efficacy(baseline)
- International Knee Documentation Committee score(baseline, 1, 3, 6, 12 months)
- Visual Analogue Scale(baseline, 1, 3, 6, 12 months)
- Overall judgment on treatment(baseline, 1, 3, 6, 12 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 3
Efficacy and Safety on Prouk for STEMI Patients in ChinaSTEMINCT02367976Suzhou RxD Biopharmaceutical Co., Ltd450
Recruiting
Not Applicable
Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old PatientsKnee OsteoarthritisNCT04901273Istituto Ortopedico Rizzoli204
Completed
Early Phase 1
Intraosseous With Intra-articular Injection of Platelet Rich Plasma in Treatment of Knee OsteoarthritisOsteoarthritis, KneeNCT03329235Cangzhou Central Hospital86
Unknown
Not Applicable
Evaluating the Role of Intra-articular Injections of Platelet Rich Plasma (PRP) in Patients With Rheumatoid Arthritis.RA - Rheumatoid ArthritisNCT04264494Dalia Salah Saif100
Withdrawn
Phase 2
INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701Metastatic Gastric CancerMetastatic Lung CancerMetastatic Breast CancerNCT05703555Erasmus Medical Center