Knee Arthritis, OsteoarthritisNCT07558980
Platelet-Rich Plasma Composition and Clinical Effects in Knee Osteoarthritis
A study testing intra-articular administration of plasma rich in platelets (PRP) in people with Knee Arthritis, Osteoarthritis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
This is a prospective, observational cohort study involving 40 patients with primary knee osteoarthritis hospitalized in a rehabilitation hospital in Cluj-Napoca. All participants will receive intra-articular platelet-rich plasma (PRP) injections. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Arthritis, Osteoarthritis
- What is being tested?
- intra-articular administration of plasma rich in platelets (PRP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRomania
- Study dates
- 15 Oct 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 80 years
- Diagnosis of unilateral or bilateral gonarthrosis radiological grade 2-3 Kellgren-Lawrence
- Knee joint pain greater than 4 on the VAS scale
- History of knee joint pain for at least 6 months
- Patients who are to receive an inpatient PRP injection
Who cannot join
- Diagnosis of secondary gonarthrosis
- History of inflammatory rheumatological disease or gout
- History of recent minor (1 month) or major (2 years) trauma to the knee joint
- History of knee surgery or arthroscopy
- Infiltrations, physiotherapy or other knee treatments in the last 3 months
- Diagnosis of neoplasia, hematological or immunological diseases
- Clinical or biological signs of acute infection
- Coagulation disorders
Trial locations and contacts
1 site in 1 country.
Romania1 site
" Iuliu Hatieganu" University of medicine and Pharmacy
Cluj-Napoca, Cluj, 400347
About this study
Official title: Study of the Composition of Platelet-rich Plasma and Its Clinical and Molecular Effect in the Biological Treatment of Knee Arthrosis
This is a prospective, observational cohort study involving 40 patients with primary knee osteoarthritis hospitalized in a rehabilitation hospital in Cluj-Napoca. All participants will receive intra-articular platelet-rich plasma (PRP) injections. The study aims to analyze PRP composition and inflammatory biomarkers to better understand disease mechanisms and evaluate treatment effectiveness.
Read the detailed description
The study is designed as an observational, longitudinal, prospective cohort investigation focused on patients with primary degenerative pathology of the knee joint, specifically primary gonarthrosis. The target population includes individuals diagnosed with knee osteoarthritis, while the accessible population consists of patients admitted to the Clinical Rehabilitation Hospital in Cluj-Napoca.
A total of 40 consecutive patients meeting inclusion criteria will be enrolled. Each participant will undergo treatment consisting of an intra-articular injection of platelet-rich plasma (PRP) at the knee level. The consecutive inclusion approach reduces selection bias and reflects routine clinical practice.
A central component of the study is the biological characterization of PRP. The investigators will analyze its composition, particularly focusing on growth factors such as platelet-derived growth factor (PDGF), transforming growth factor beta 1 (TGF-β1), and insulin-like growth factor 1 (IGF-1). This analysis is intended to contribute to the standardization of PRP therapy in knee osteoarthritis.
In parallel, the study will assess systemic inflammatory status by measuring circulating biomarkers, including interleukins (IL-1β, IL-8, IL-18) and tumor necrosis factor alpha (TNF-α). Monitoring these biomarkers allows evaluation of the inflammatory response and provides insight into the biological effects of PRP on the intra-articular environment.
Overall, the study seeks to clarify both the pathophysiological mechanisms underlying knee osteoarthritis and the therapeutic mechanisms of PRP, while also assessing its clinical effectiveness through changes in inflammatory markers.
- Conditions
- Knee Arthritis, Osteoarthritis
- Being tested
- intra-articular administration of plasma rich in platelets (PRP)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular administration of plasma rich in platelets (PRP)Procedure or surgery
intraarticular injection
| Study group | Role | What they receive |
|---|---|---|
| 40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets | Other | intra-articular administration of plasma rich in platelets (PRP) Receives: Procedure: intra-articular administration of plasma rich in platelets (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity assessed using the Visual Analogue Scale (VAS)
Measured: Baseline and at 4 weeks
Functional status and symptom severity
Functional status and symptom severity measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire Health-related quality of life evaluated with the SF-36 questionnaire
Measured: Basline and at 4 weeks
Systemic inflammatory markers
Systemic inflammatory markers: IL-1β, IL-8, IL-18, TNF-α
Measured: Baseline and at 4 weeks
General inflammatory indicators
General inflammatory indicators: erythrocyte sedimentation rate (ESR)
Measured: Baseline and at 4 weeks
General inflammatory indicators 2
General inflammatory indicators: C-reactive protein (CRP)
Measured: Baseline and at 4 weeks
Growth factor profile of PRP
transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), insulin-like growth factor 1 (IGF-1), and vascular endothelial growth factor (VEGF)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start15 Oct 2025
- Primary completion20 Nov 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis, OsteoarthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viorela Mihaela Ciortea, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558980
- Sponsor's protocol ID
- IuliuHatieganuUniversity
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Composition of Platelet-rich Plasma and Its Clinical and Molecular Effect in the Biological Treatment of Knee Arthrosis
- ClinicalTrials.gov ID
- NCT07558980
- Acronym / sponsor ID
- IuliuHatieganuUniversity
- Conditions
- Knee Arthritis, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 30 Apr 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.
This is a prospective, observational cohort study involving 40 patients with primary knee osteoarthritis hospitalized in a rehabilitation hospital in Cluj-Napoca. All participants will receive intra-articular platelet-rich plasma (PRP) injections. The study aims to analyze PRP composition and inflammatory biomarkers to better understand disease mechanisms and evaluate treatment effectiveness.
Detailed description
The study is designed as an observational, longitudinal, prospective cohort investigation focused on patients with primary degenerative pathology of the knee joint, specifically primary gonarthrosis. The target population includes individuals diagnosed with knee osteoarthritis, while the accessible population consists of patients admitted to the Clinical Rehabilitation Hospital in Cluj-Napoca.
A total of 40 consecutive patients meeting inclusion criteria will be enrolled. Each participant will undergo treatment consisting of an intra-articular injection of platelet-rich plasma (PRP) at the knee level. The consecutive inclusion approach reduces selection bias and reflects routine clinical practice.
A central component of the study is the biological characterization of PRP. The investigators will analyze its composition, particularly focusing on growth factors such as platelet-derived growth factor (PDGF), transforming growth factor beta 1 (TGF-β1), and insulin-like growth factor 1 (IGF-1). This analysis is intended to contribute to the standardization of PRP therapy in knee osteoarthritis.
In parallel, the study will assess systemic inflammatory status by measuring circulating biomarkers, including interleukins (IL-1β, IL-8, IL-18) and tumor necrosis factor alpha (TNF-α). Monitoring these biomarkers allows evaluation of the inflammatory response and provides insight into the biological effects of PRP on the intra-articular environment.
Overall, the study seeks to clarify both the pathophysiological mechanisms underlying knee osteoarthritis and the therapeutic mechanisms of PRP, while also assessing its clinical effectiveness through changes in inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets | Other | Procedure: intra-articular administration of plasma rich in platelets (PRP)intra-articular administration of plasma rich in platelets (PRP) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 and 80 years
- Diagnosis of unilateral or bilateral gonarthrosis radiological grade 2-3 Kellgren-Lawrence
- Knee joint pain greater than 4 on the VAS scale
- History of knee joint pain for at least 6 months
- Patients who are to receive an inpatient PRP injection
Key exclusion criteria (8 listed)
- Diagnosis of secondary gonarthrosis
- History of inflammatory rheumatological disease or gout
- History of recent minor (1 month) or major (2 years) trauma to the knee joint
- History of knee surgery or arthroscopy
- Infiltrations, physiotherapy or other knee treatments in the last 3 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 |
|---|---|---|
| intra-articular administration of plasma rich in platelets (PRP)intraarticular injection | Procedure or surgery | 40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets |
Primary outcome
Pain intensity
Time frame: Baseline and at 4 weeks
Pain intensity assessed using the Visual Analogue Scale (VAS)
Functional status and symptom severity
Time frame: Basline and at 4 weeks
Functional status and symptom severity measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire Health-related quality of life evaluated with the SF-36 questionnaire
Systemic inflammatory markers
Time frame: Baseline and at 4 weeks
Systemic inflammatory markers: IL-1β, IL-8, IL-18, TNF-α
General inflammatory indicators
Time frame: Baseline and at 4 weeks
General inflammatory indicators: erythrocyte sedimentation rate (ESR)
General inflammatory indicators 2
Time frame: Baseline and at 4 weeks
General inflammatory indicators: C-reactive protein (CRP)
Growth factor profile of PRP
Time frame: Baseline
transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), insulin-like growth factor 1 (IGF-1), and vascular endothelial growth factor (VEGF)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-articular administration of plasma rich in platelets (PRP) in people with Knee Arthritis, Osteoarthritis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 30 Apr 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 Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline and at 4 weeks). The study lists 6 primary outcomes in all. 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 30 Apr 2026.