Efficacy and Safety of Intra-articular Injections of Froz... | NCT07329361

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

NCT07329361

Sponsor

MiKS Hospital

Status

Recruiting

Last Update Posted

Jan 9, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Knee Osteoarthristis

Interventions

Platelet Rich Plasma
Platelet Rich Plasma

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 16, 2025Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Dec 10, 2025

First Submission Date that Met QC Criteria

Dec 26, 2025

First Posted Date

Jan 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2025

Last Update Posted Date

Jan 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Frozen Platelet-Rich Plasma	Experimental		Other: Platelet Rich Plasma
Platelet-Rich Plasma	Active Comparator		Other: Platelet Rich Plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet Rich Plasma	Other	Platelet-rich plasma stored by freezing	Frozen Platelet-Rich Plasma

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided