Knee OsteoarthritisNCT07828561
Clinical Outcomes of Intraarticular Platelet-Rich Plasma Injection in Knee Osteoarthritis
A study testing Platelet-Rich Plasma (PRP) in people with Knee Osteoarthritis and Osteoarthritis (OA), run by KIST Medical and Teaching Hospital at 1 site in Nepal.
Trial summary
This prospective single-arm interventional study was designed to assess the short-term clinical outcomes of intra-articular platelet-rich plasma (PRP) injections in patients with Kellgren-Lawrence grade II and III knee osteoarthritis. A total of 59 patients (61 knees) were enrolled and followed for six months. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis, Osteoarthritis (OA), Degenerative Joint Disease of Knee
- What is being tested?
- Platelet-Rich Plasma (PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteNepal
- Study dates
- 5 Nov 2022to 5 Nov 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >50 years
- Persistent knee pain >4 weeks (In the case of patients presenting with bilateral knee pain, the knee with more severe symptoms was selected for study purposes.)
- Patient must have undergone conservative treatment for at least 4 weeks.
- Radiologically diagnosed as knee osteoarthritis with Kellgren-Lawrence grading scale, grades 2 and 3
- Primary osteoarthritis of the knee
Who cannot join
- Immunosuppressed patients (Examples: uncontrolled diabetes, HIV, under corticosteroid medication, etc.)
- History of surgery around the knee joint
- History of significant knee injury
- Patients diagnosed with connective tissue disorders, inflammatory disorders of joints, congenital anomalies of the lower extremity, tumors, and metabolic diseases of bone
- Patients who had received intra-articular steroid injections within the past 6 months
- Patient who has not attempted conservative treatment.
Show all 14Show fewer
- Presence or suspected of infection or ulceration at the injection site.
- Patients with a platelet count less than 1.5 lakhs/microliters
- Congenital anomalies of the lower extremity
- Patients on NSAIDs 2 days before and 2 days after PRP injection.
- Patients with coexisting backache, hip pain
- Pregnant or lactating females.
- Cases where the diagnosis is uncertain.
- Patients not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Interventional Study on Intraarticular Platelet-Rich Plasma Injection in Patients With Kellgren-Lawrence Grade II and III Knee Osteoarthritis
This prospective single-arm interventional study was designed to assess the short-term clinical outcomes of intra-articular platelet-rich plasma (PRP) injections in patients with Kellgren-Lawrence grade II and III knee osteoarthritis. A total of 59 patients (61 knees) were enrolled and followed for six months. Pain and function were measured using the Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Safety monitoring included documentation of injection-site pain and other adverse events.
Read the detailed description
Osteoarthritis of the knee is a leading cause of disability worldwide. Platelet-rich plasma (PRP) therapy has emerged as a biologic intervention to enhance cartilage repair and reduce inflammation. This study was conducted at KIST Medical College and Teaching Hospital, Lalitpur, Nepal, between November 2022 and November 2023. Patients aged ≥50 years with KL grade II or III knee OA were enrolled. PRP was prepared using a double-spin centrifugation protocol to yield leukocyte-poor PRP, and 5 ml was injected intraarticularly via an inferolateral approach. Outcomes were assessed at baseline, 2, 4, and 6 months using validated instruments (VAS and WOMAC). Adverse events were monitored throughout the follow-up period.
- Being tested
- Platelet-Rich Plasma (PRP)
- Keywords
- Osteoarthritis, knee pain, Platelet rich plasma, PRP, Regenerative Therapy, WOMAC, VAS
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma (PRP)Biological
Autologous PRP prepared from 16 ml of venous blood using a double-spin centrifugation protocol (first spin ~700 g for 12 minutes, second spin ~1700 g for 7 minutes). The final product was leukocyte-poor PRP with a mean 4.2-fold increase in platelet concentration. A single 5 ml dose was injected intraarticularly via an inferolateral approach using an 18G needle under aseptic precautions.
| Study group | Role | What they receive |
|---|---|---|
| PRP Injection | Experimental | All participants received a single intraarticular injection of 5 ml leukocyte-poor platelet-rich plasma (PRP). The PRP was prepared using a double-spin centrifugation protocol and injected via an inferolateral approach with the knee flexed to 70°. Post-injection care included ice fomentation and range of motion exercises. NSAIDs were avoided for 2 days before and after injection; paracetamol was permitted for pain relief. Receives: Biological: Platelet-Rich Plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Unabbreviated scale title: Visual Analogue Scale (VAS) for pain
Range: 0 to 10
Interpretation: Higher scores indicate worse pain intensity (0 = no pain, 10 = worst imaginable pain).
Measured: Baseline to 6 months
Functional outcome
Unabbreviated scale title: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Range: 0 to 96 (total score)
Interpretation: Higher scores indicate worse pain, stiffness, and functional limitation (0 = no symptoms, 96 = extreme symptoms).
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start5 Nov 2022
- Primary completion5 Nov 2023
- Study completion5 Nov 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.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- KIST Medical and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaurav Bir Bajracharya, KIST Medical and Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828561
- Sponsor's protocol ID
- KIST-PRP-OA-079/80/38
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including baseline demographics and outcome measures, will be shared for secondary analyses.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Interventional Study on Intraarticular Platelet-Rich Plasma Injection in Patients With Kellgren-Lawrence Grade II and III Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07828561
- Acronym / sponsor ID
- KIST-PRP-OA-079/80/38
- Keywords
- Osteoarthritis, knee pain, Platelet rich plasma, PRP, Regenerative Therapy, WOMAC, VAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- KIST Medical and Teaching HospitalUniversity, hospital or other
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 5 Nov 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 18 Sep 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 prospective single-arm interventional study was designed to assess the short-term clinical outcomes of intra-articular platelet-rich plasma (PRP) injections in patients with Kellgren-Lawrence grade II and III knee osteoarthritis. A total of 59 patients (61 knees) were enrolled and followed for six months. Pain and function were measured using the Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Safety monitoring included documentation of injection-site pain and other adverse events.
Detailed description
Osteoarthritis of the knee is a leading cause of disability worldwide. Platelet-rich plasma (PRP) therapy has emerged as a biologic intervention to enhance cartilage repair and reduce inflammation. This study was conducted at KIST Medical College and Teaching Hospital, Lalitpur, Nepal, between November 2022 and November 2023. Patients aged ≥50 years with KL grade II or III knee OA were enrolled. PRP was prepared using a double-spin centrifugation protocol to yield leukocyte-poor PRP, and 5 ml was injected intraarticularly via an inferolateral approach. Outcomes were assessed at baseline, 2, 4, and 6 months using validated instruments (VAS and WOMAC). Adverse events were monitored throughout the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP Injection | Experimental | Biological: Platelet-Rich Plasma (PRP)All participants received a single intraarticular injection of 5 ml leukocyte-poor platelet-rich plasma (PRP). The PRP was prepared using a double-spin centrifugation protocol and injected via an inferolateral approach with the knee flexed to 70°. Post-injection care included ice fomentation and range of motion exercises. NSAIDs were avoided for 2 days before and after injection; paracetamol was permitted for pain relief. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >50 years
- Persistent knee pain >4 weeks (In the case of patients presenting with bilateral knee pain, the knee with more severe symptoms was selected for study purposes.)
- Patient must have undergone conservative treatment for at least 4 weeks.
- Radiologically diagnosed as knee osteoarthritis with Kellgren-Lawrence grading scale, grades 2 and 3
- Primary osteoarthritis of the knee
Key exclusion criteria (14 listed)
- Immunosuppressed patients (Examples: uncontrolled diabetes, HIV, under corticosteroid medication, etc.)
- History of surgery around the knee joint
- History of significant knee injury
- Patients diagnosed with connective tissue disorders, inflammatory disorders of joints, congenital anomalies of the lower extremity, tumors, and metabolic diseases of bone
- Patients who had received intra-articular steroid injections within the past 6 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 Plasma (PRP)Autologous PRP prepared from 16 ml of venous blood using a double-spin centrifugation protocol (first spin ~700 g for 12 minutes, second spin ~1700 g for 7 minutes). The final product was leukocyte-poor PRP with a mean 4.2-fold increase in platelet concentration. A single 5 ml dose was injected intraarticularly via an inferolateral approach using an 18G needle under aseptic precautions. | Biological | PRP Injection |
Primary outcome
Pain intensity
Time frame: Baseline to 6 months
Unabbreviated scale title: Visual Analogue Scale (VAS) for pain Range: 0 to 10 Interpretation: Higher scores indicate worse pain intensity (0 = no pain, 10 = worst imaginable pain).
Functional outcome
Time frame: Baseline to 6 months
Unabbreviated scale title: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Range: 0 to 96 (total score) Interpretation: Higher scores indicate worse pain, stiffness, and functional limitation (0 = no symptoms, 96 = extreme symptoms).
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 18 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including baseline demographics and outcome measures, will be shared for secondary analyses.
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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 Platelet-Rich Plasma (PRP) in people with Knee Osteoarthritis and Osteoarthritis (OA), run by KIST Medical and Teaching Hospital at 1 site in Nepal.
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 14 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 18 Sep 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 Nepal. 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 to 6 months). The study lists 2 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 18 Sep 2026.