Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis

Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis: Randomized Control Trial

Evaluation of intra-articular injections in knee osteoarthritis using frozen-stored PRP. Compared with intra-articular injections of PRP applied at the time of collection.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthristis
• Intervention / Treatment: Other: Platelet Rich Plasma; Other: Platelet Rich Plasma

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Araba/Álava
    • Vitoria-Gasteiz, Araba/Álava, Spain, 01010
      • Recruiting
      • Arthroscopic Surgery Unit, MiKS Hosptial
      • Contact: Diego Delgado; Phone Number: 0034 945 25 20 77; Email: diego.delgado@hospitalmiks.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients of both sexes.
• Aged between 40 and 85 years old.
• Diagnosed with osteoarthritis through clinical radiological examination.
• Joint pain equal to or less than 75 points on the KOOS (pain).
• Radiological severity grades 1, 2, and 3 according to the Ahlbäck scale.
• Indication for intra-articular PRP infiltration.
• Body Mass Index values between 20 and 35.
• Negative serological tests for syphilis, HIV, HBV, and HCV.
• Possibility of observation during the follow-up period.
• Signature of informed consent.

Exclusion Criteria:

• Body mass index >35
• Diagnosed polyarticular disease.
• Previous arthroscopy in the last year.
• Severe mechanical deformity.
• Intra-articular hyaluronic acid injection in the last 12 months.
• Intra-articular corticosteroid or PRP injection in the last 6 months.
• Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
• Anemia or other hematological disorders.
• Positive serological tests for SYPHILIS, HIV, HBV, and HCV.
• Undergoing immunosuppressive treatments.
• Poorly controlled diabetes mellitus.
• Patients allergic to paracetamol.
• Pregnancy or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frozen Platelet-Rich Plasma	Other: Platelet Rich Plasma; Platelet-rich plasma stored by freezing; Other: Platelet Rich Plasma; Fresh Platelet-Rich Plasma
Active Comparator: Platelet-Rich Plasma	Other: Platelet Rich Plasma; Platelet-rich plasma stored by freezing; Other: Platelet Rich Plasma; Fresh Platelet-Rich Plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS - Knee Injury and Osteoarthritis Outcome Score	From 0 (worst outcome) to 100 (best outcome)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS - Knee Injury and Osteoarthritis Outcome Score	From 0 (worst outcome) to 100 (best outcome)	2 months
VAS - Visual Analog Scale	From 0 (best outcome) to 10 (worst outcome)	2 months
VAS - Visual Analog Scale	From 0 (best outcome) to 10 (worst outcome)	6 months
Lequesne Index	A patient-completed questionnaire used to measure the severity of osteoarthritis assessing pain and function. From 0 (best outcome) to 24 (worst outcome)	2 months
Lequesne Index	A patient-completed questionnaire used to measure the severity of osteoarthritis assessing pain and function. From 0 (best outcome) to 24 (worst outcome)	6 months

Collaborators and Investigators

• Sponsor: MiKS Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 26, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: UCA-17/EC/25/CON

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No