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

NCT07329361 | Recruiting

• 1 other identifier: UCA-17/EC/25/CON
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthristis

Outcome Measures

Primary Outcomes (1)

• KOOS - Knee Injury and Osteoarthritis Outcome Score

  From 0 (worst outcome) to 100 (best outcome)

  6 months

Secondary Outcomes (5)

• KOOS - Knee Injury and Osteoarthritis Outcome Score

  2 months

• VAS - Visual Analog Scale

  2 months

• VAS - Visual Analog Scale

  6 months

• Lequesne Index

  2 months

• Lequesne Index

  6 months

Study Arms (2)

Frozen Platelet-Rich Plasma

EXPERIMENTAL

Other: Platelet Rich Plasma

Platelet-Rich Plasma

ACTIVE COMPARATOR

Other: Platelet Rich Plasma

Interventions

Platelet Rich Plasma OTHER

Platelet-rich plasma stored by freezing

Frozen Platelet-Rich Plasma

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiKS Hospital: lead

Study Sites (1)

Arthroscopic Surgery Unit, MiKS Hosptial

Vitoria-Gasteiz, Araba/Álava, 01010, Spain

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 9, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

ES (1)