Knee OsteoarthristisNCT07329361
Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis
A study testing Platelet Rich Plasma in people with Knee Osteoarthristis, run by MiKS Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Platelet Rich Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 16 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Arthroscopic Surgery Unit, MiKS Hosptial
Vitoria-Gasteiz, Araba/Álava, 01010
Diego Delgado, 0034 945 25 20 77, diego.delgado@hospitalmiks.com
About this study
Official title: 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.
- Conditions
- Knee Osteoarthristis
- Being tested
- Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaOther
Platelet-rich plasma stored by freezing
Platelet Rich PlasmaOther
Fresh Platelet-Rich Plasma
| Study group | Role | What they receive |
|---|---|---|
| Frozen Platelet-Rich Plasma | Experimental | Not described Receives: Other: Platelet Rich Plasma |
| Platelet-Rich Plasma | Active comparator | Not described Receives: Other: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS - Knee Injury and Osteoarthritis Outcome Score
From 0 (worst outcome) to 100 (best outcome)
Measured: 6 months
Secondary outcomes (5)
KOOS - Knee Injury and Osteoarthritis Outcome Score
From 0 (worst outcome) to 100 (best outcome)
Measured: 2 months
VAS - Visual Analog Scale
From 0 (best outcome) to 10 (worst outcome)
Measured: 2 months
VAS - Visual Analog Scale
From 0 (best outcome) to 10 (worst outcome)
Measured: 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)
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start16 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiKS Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329361
- Sponsor's protocol ID
- UCA-17/EC/25/CON
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07329361
- Acronym / sponsor ID
- UCA-17/EC/25/CON
- Conditions
- Knee Osteoarthristis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MiKS HospitalUniversity, hospital or other
- Study start
- 16 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frozen Platelet-Rich Plasma | Experimental | Other: Platelet Rich Plasma |
| Platelet-Rich Plasma | Active comparator | Other: Platelet Rich Plasma |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich PlasmaPlatelet-rich plasma stored by freezing | Other | Frozen Platelet-Rich Plasma |
| Platelet Rich PlasmaFresh Platelet-Rich Plasma | Other | Platelet-Rich Plasma |
Primary outcome
KOOS - Knee Injury and Osteoarthritis Outcome Score
Time frame: 6 months
From 0 (worst outcome) to 100 (best outcome)
5 secondary outcomes
KOOS - Knee Injury and Osteoarthritis Outcome Score
Time frame: 2 months
VAS - Visual Analog Scale
Time frame: 2 months
VAS - Visual Analog Scale
Time frame: 6 months
Lequesne Index
Time frame: 2 months
Lequesne Index
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arthroscopic Surgery Unit, MiKS Hosptial
Vitoria-Gasteiz, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma in people with Knee Osteoarthristis, run by MiKS Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS - Knee Injury and Osteoarthritis Outcome Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.