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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07329361

Enrollment

Registered

2026-01-09

Start date

2025-12-16

Completion date

2027-12-31

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthristis

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.

Interventions

OTHERPlatelet Rich Plasma

Platelet-rich plasma stored by freezing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026