Platelets-rich PlasmaNCT06082531
Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis
A study testing Sodium hyaluronate injection in people with Platelets-rich Plasma and Osteoarthritis Knees Both, run by Xijing Hospital at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of PRP injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Platelets-rich Plasma, Osteoarthritis Knees Both, Meniscus Disorder
- What is being tested?
- Sodium hyaluronate injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2026
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The age range of the participants was 20 to 60 years old. Through a comprehensive clinical and imaging examination, it was conclusively determined that the individuals had knee osteoarthritis or experienced injuries to the cart, and meniscus surrounding the knee joint.
- The preoperative routine tests and examinations revealed no contraindications.
- Revised sentence: "Informed consent of the patient
Who cannot join
- The platelet count or function exhibits significant abnormalities、Systemic infection transmitted through the bloodstream.
- Prolonged usage of anti-inflammatory drugs and systemic corticoid administration.
- In injection site or damage to the skin.
- Patients with tumors or undergoing radiotherapy and chemotherapy.
- Pregnant or breastfeeding women.
- Individuals with mental illnesses who are unable to cooperate with follow-up procedures.
- Contraindications for MRI、Patients or their families do consent to participate in the study.
- Other circumstances that render participation in the study unsuitable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shannxi, 710034
Yanyan Jia, +862984771794, xiyyllwyh@163.com
About this study
Official title: Therapeutic Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis and Periarticular Tissue Injury
To evaluate the safety and effectiveness of PRP injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury.
- Being tested
- Sodium hyaluronate injection
- Keywords
- platelets-rich plasma, Osteoarthritis, Cartilage Injury, Meniscus Injury
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hyaluronate injectionDrug
The control group was injected into the joint cavity with sodium hyaluronate injection..
| Study group | Role | What they receive |
|---|---|---|
| Preoperative | No intervention | Not described |
| postoperative (6 weeks) | Experimental | The patients were injected with PRP. Receives: Drug: Sodium hyaluronate injection |
| postoperative (3 months) | Experimental | The patients were injected with PRP. Receives: Drug: Sodium hyaluronate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray
The postoperative plain X-ray film was utilized for the assessment of knee joint deformity, stenosis of the joint space, and hyperplasia of osteophytes.
Measured: pre-operation,3 weeks after treatment, 6 months after treatment
CT
The application of three-dimensional CT scan for the assessment of articular cartilage defects.
Measured: pre-operation,3 weeks after treatment, 6 months after treatment
MRI
The injury of ligaments, meniscus, and the knee joint was assessed using MRI.
Measured: pre-operation,3 weeks after treatment, 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Platelets-rich PlasmaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082531
- Sponsor's protocol ID
- KY20232210
- Status last verified
- Jul 2026
- First submitted
- 9 Oct 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramos-Gonzalez G, Salazar L, Wittig O, Diaz-Solano D, Cardier JE. The effects of mesenchymal stromal cells and platelet-rich plasma treatments on cutaneous wound healing. Arch Dermatol Res. 2023 May;315(4):815-823. doi: 10.1007/s00403-022-02451-y. Epub 2022 Nov 3.
PubMed 36326886Zhang Y, Xing F, Luo R, Duan X. Platelet-Rich Plasma for Bone Fracture Treatment: A Systematic Review of Current Evidence in Preclinical and Clinical Studies. Front Med (Lausanne). 2021 Aug 3;8:676033. doi: 10.3389/fmed.2021.676033. eCollection 2021.
PubMed 34414200
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis and Periarticular Tissue Injury
- ClinicalTrials.gov ID
- NCT06082531
- Acronym / sponsor ID
- KY20232210
- Keywords
- platelets-rich plasma, Osteoarthritis, Cartilage Injury, Meniscus Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Oct 2023 (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.
To evaluate the safety and effectiveness of PRP injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preoperative | No intervention | – |
| postoperative (6 weeks) | Experimental | Drug: Sodium hyaluronate injectionThe patients were injected with PRP. |
| postoperative (3 months) | Experimental | Drug: Sodium hyaluronate injectionThe patients were injected with PRP. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The age range of the participants was 20 to 60 years old. Through a comprehensive clinical and imaging examination, it was conclusively determined that the individuals had knee osteoarthritis or experienced injuries to the cart, and meniscus surrounding the knee joint.
- The preoperative routine tests and examinations revealed no contraindications.
- Revised sentence: "Informed consent of the patient
Key exclusion criteria (8 listed)
- The platelet count or function exhibits significant abnormalities、Systemic infection transmitted through the bloodstream.
- Prolonged usage of anti-inflammatory drugs and systemic corticoid administration.
- In injection site or damage to the skin.
- Patients with tumors or undergoing radiotherapy and chemotherapy.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Sodium hyaluronate injectionThe control group was injected into the joint cavity with sodium hyaluronate injection.. | Drug | postoperative (3 months), postoperative (6 weeks) |
Primary outcome
X-ray
Time frame: pre-operation,3 weeks after treatment, 6 months after treatment
The postoperative plain X-ray film was utilized for the assessment of knee joint deformity, stenosis of the joint space, and hyperplasia of osteophytes.
CT
Time frame: pre-operation,3 weeks after treatment, 6 months after treatment
The application of three-dimensional CT scan for the assessment of articular cartilage defects.
MRI
Time frame: pre-operation,3 weeks after treatment, 6 months after treatment
The injury of ligaments, meniscus, and the knee joint was assessed using MRI.
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 30 Jul 2026.
- Background: PubMed 36326886Ramos-Gonzalez G, Salazar L, Wittig O, Diaz-Solano D, Cardier JE. The effects of mesenchymal stromal cells and platelet-rich plasma treatments on cutaneous wound healing. Arch Dermatol Res. 2023 May;315(4):815-823. doi: 10.1007/s00403-022-02451-y. Epub 2022 Nov 3.
- Background: PubMed 34414200Zhang Y, Xing F, Luo R, Duan X. Platelet-Rich Plasma for Bone Fracture Treatment: A Systematic Review of Current Evidence in Preclinical and Clinical Studies. Front Med (Lausanne). 2021 Aug 3;8:676033. doi: 10.3389/fmed.2021.676033. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hyaluronate injection in people with Platelets-rich Plasma and Osteoarthritis Knees Both, run by Xijing Hospital at 1 site in China.
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 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: looking for participants now, as of the sponsor's last update on 30 Jul 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 China. 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?
Contact Yanyan Jia (+862984771794, xiyyllwyh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
X-ray (time frame: pre-operation,3 weeks after treatment, 6 months after treatment). The study lists 3 primary outcomes in all. 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 NCT06082531, which also lists 2 linked publications.
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 Jul 2026.