Knee OsteoarthritisPRPNCT04807270

PRP Effectiveness in Knee Osteoarthritis

A study testing Intra-articular T-LAB / Next PRP Syringe, Intra-articular T-LAB / PRP KIT injection and Intra-articular SALINE injection in people with Knee Osteoarthritis, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of our study is to determine the effects of intra-articular Platelet-Rich Plasma (PRP) prepared with two different techniques on pain intensity, functional status, quality of life, functional balance and femoral cartilage thickness in patients with knee osteoarthritis. Read more about this study

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Intra-articular T-LAB / Next PRP Syringe, Intra-articular T-LAB / PRP KIT injection and Intra-articular SALINE injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 20 May 2021to 1 Jan 2023
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 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with chronic symptomatic knee pain between the ages of 30 and 75 years
Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
The ability to walk independently

Who cannot join

Previous treatment with an autologous blood product or stem cell preparation
Severe knee effusion
Concomitant severe meniscus or ligament injury
Recent cancer or other tumors
History of knee surgery
Previous diagnosis of a neuromuscular, infectious, or inflammatory disease

Show all 9Show fewer

Bleeding disorders and/or use of warfarin
Body mass index above 40 kg/m²
Cardiac or systemic diseases that could affect participation in the exercise program

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatıh, 34034

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Efficacy of Two Platelet-Rich Plasma Treatments For Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial

Read the detailed description

Osteoarthritis (OA) is the most common form of chronic joint disease. Platelet-Rich Plasma (PRP) is an injection therapy used to treat chronic, painful musculoskeletal conditions, including knee OA. In this prospective, randomized controlled, double blind, interventional study, out of 154 patients who applied to the physical medicine and rehabilitation department, 96 patients who met the eligibility criteria were divided into the pure PRP group without anticoagulant (n=32), amber PRP group (n=32), and saline group (n=32). A home exercise program for knee osteoarthritis will be provided to all three groups, and the program will be followed by weekly phone calls. During the follow-up period, patients will be asked to continue their current medical treatments and not to changes to their activities of daily living. Participants are going to be evaluated using visual analog scale (VAS) scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and a numeric rating scale for quality of life (NRS) baseline and at 1, 3, and 6-month follow-up periods, time Up and Go (TUG) test at the baseline and at 3 and 6 months after treatment, and changes in femoral cartilage thickness by ultrasound measurement at the baseline and at 6 months after treatment

Conditions: Knee Osteoarthritis
Being tested: Intra-articular T-LAB / Next PRP Syringe, Intra-articular T-LAB / PRP KIT injection, Intra-articular SALINE injection
Keywords: knee osteoarthritis, platelet rich plasma
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intra-articular T-LAB / Next PRP SyringeOther
Anticoagulant-free pure PRP will be prepared using T-LAB / Next PRP Syringe. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
Intra-articular T-LAB / PRP KIT injectionOther
PRP containing anticoagulant will be prepared using T-LAB / PRP KIT. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
Intra-articular SALINE injectionOther
Similar to the PRP protocol, 4 mL of 0.9% sodium chloride will be injected intra-articularly. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

Study groups in NCT04807270
Study group	Role	What they receive
T-LAB / NEXT PRP SYRINGE	Active comparator	In the first group (PRP1 group; non-anticoagulant pure PRP), prepared with Next PRP Syringe in 3 sessions will be applied. Receives: Other: Intra-articular T-LAB / Next PRP Syringe
T-LAB / PRP KIT	Active comparator	In the second group (PRP2 group; amber PRP) prepared with T-LAB / PRP KIT in 3 sessions will be applied. Receives: Other: Intra-articular T-LAB / PRP KIT injection
SALINE	Sham comparator	In the third group (saline group), prepared with SALINE in 3 sessions will be applied. Receives: Other: Intra-articular SALINE injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline activity pain score at 1-months, 3-months and 6-months
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month, 6-month

Secondary outcomes (5)

Change from baseline activity pain score at 1-months, 3-months and 6-months
Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed, with possible ranges of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The sum of the scores for the three subscales gives a total WOMAC score. High scores are associated with more pain, stiffness, and poor function, while low scores indicate well-being.
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline quality of life and global assessment at 1-months, 3-months and 6-months
Quality of life and global assessment evaluate using a numeric rating scale (NRS) ranging from 0 to 10. Higher scores mean a worse outcome..
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline functional balance at 3-months and 6-months
The Timed Up and Go test requires the person to stand up from a standard chair in which they are sitting, walk 3 meters at a comfortable speed to the marked place on the floor, turn around, walk backwards to the starting point, and return to the sitting position in the chair. The time taken for the person to complete the test is measured in seconds. The timing of the test is related to the function.
Measured: Baseline, 3-month, 6-month
Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months
Distal femoral cartilage thickness will be evaluated by the same clinician. We will use the MyLab60 model ultrasonography device and a high-resolution 7-12 MHz linear probe available in our clinic. During measurement, patients will be prone with knees in full flexion and ankles in neutral. The probe will be placed axially in the suprapatellar area at the outer edge of the patella. The distal femoral cartilage will be imaged anechogenically between the hyperechogenic bony cortex and suprapatellar fat. Next, we will measure the distance between the thin hyperechoic line of the synovial cavity on the stratified face and the hyperechoic sharp line on the bony face of the cartilage. This will be recorded as the thickness of the cartilage. For each intervention knee, cartilage thickness will be determined by recording three measurements from the midpoint: lateral condyle, intercondylar area, and medial condyle.
Measured: Baseline, 6-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 20211 Jan 2023

First posted19 Mar 2021
Study start20 May 2021
Primary completion20 Nov 2022
Study completion1 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
More trials run by Istanbul UniversityThe sponsor's other registered studies.
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: Participant, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04807270
Sponsor's protocol ID: Istanbul Universty PRP
Acronym: PRP
Status last verified: Mar 2023
First submitted: 17 Mar 2021
Last updated: 22 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Boosting Exercise Adherence in Knee Osteoarthritis
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Tempo-controlled Low-load Resistance Training in Patients With Knee Osteoarthritis.
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Efficacy of Two Platelet-Rich Plasma Treatments For Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04807270
Acronym / sponsor ID: PRP / Istanbul Universty PRP
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis, platelet rich plasma
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Istanbul UniversityUniversity, hospital or other
Study start: 20 May 2021 (actual)
Primary completion: 20 Nov 2022 (actual)
Study completion: 1 Jan 2023 (actual)
First posted: 19 Mar 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
T-LAB / NEXT PRP SYRINGE	Active comparator	Other: Intra-articular T-LAB / Next PRP SyringeIn the first group (PRP1 group; non-anticoagulant pure PRP), prepared with Next PRP Syringe in 3 sessions will be applied.
T-LAB / PRP KIT	Active comparator	Other: Intra-articular T-LAB / PRP KIT injectionIn the second group (PRP2 group; amber PRP) prepared with T-LAB / PRP KIT in 3 sessions will be applied.
SALINE	Sham comparator	Other: Intra-articular SALINE injectionIn the third group (saline group), prepared with SALINE in 3 sessions will be applied.

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with chronic symptomatic knee pain between the ages of 30 and 75 years
Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
The ability to walk independently

Key exclusion criteria (9 listed)

Previous treatment with an autologous blood product or stem cell preparation
Severe knee effusion
Concomitant severe meniscus or ligament injury
Recent cancer or other tumors
History of knee surgery

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 T-LAB / Next PRP SyringeAnticoagulant-free pure PRP will be prepared using T-LAB / Next PRP Syringe. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.	Other	T-LAB / NEXT PRP SYRINGE
Intra-articular T-LAB / PRP KIT injectionPRP containing anticoagulant will be prepared using T-LAB / PRP KIT. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.	Other	T-LAB / PRP KIT
Intra-articular SALINE injectionSimilar to the PRP protocol, 4 mL of 0.9% sodium chloride will be injected intra-articularly. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.	Other	SALINE

Primary outcome

Change from baseline activity pain score at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome

5 secondary outcomes

Change from baseline activity pain score at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline quality of life and global assessment at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline functional balance at 3-months and 6-months
Time frame: Baseline, 3-month, 6-month
Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months
Time frame: Baseline, 6-month

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 22 May 2026.

Related trials for Knee Osteoarthritis

Not yet recruitingPhase 2
PPV-06 Vaccine in Inflammatory Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Boosting Exercise Adherence in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Tempo-controlled Low-load Resistance Training in Patients With Knee Osteoarthritis.
Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases

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.

Demirhan Diracoglu, Prof. study director

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Ekin I Sen, Asst. Prof. principal investigator

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 9 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 22 May 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?

Change from baseline activity pain score at 1-months, 3-months and 6-months (time frame: Baseline, 1-month, 3-month, 6-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04807270.

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 22 May 2026.