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

NCT ID: NCT07329361

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthristis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Frozen Platelet-Rich Plasma

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type OTHER

Platelet-rich plasma stored by freezing

Platelet-Rich Plasma

Group Type ACTIVE_COMPARATOR

Platelet Rich Plasma

Intervention Type OTHER

Fresh Platelet-Rich Plasma

Interventions

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Platelet Rich Plasma

Platelet-rich plasma stored by freezing

Intervention Type OTHER

Platelet Rich Plasma

Fresh Platelet-Rich Plasma

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MiKS Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arthroscopic Surgery Unit, MiKS Hosptial

Vitoria-Gasteiz, Araba/Álava, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Diego Delgado

Role: primary

0034 945 25 20 77

Other Identifiers

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UCA-17/EC/25/CON

Identifier Type: -

Identifier Source: org_study_id

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