Osteoarthritis KneeEarly Phase 1NCT05742061
Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients
A Early Phase 1 study testing Corticosteroid and Platelet Rich Plasma in people with Osteoarthritis Knee and Corticosteroid, run by Benha University.
Trial summary
Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis Knee, Corticosteroid, Platelet Rich Plasma
- What is being tested?
- Corticosteroid and Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Dec 2023
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs.
- Patients diagnosed according to ACR classification criteria.
Who cannot join
- Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies.
- Those receiving treatment with anticoagulant , anti_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs.
- Pregnant and breast feeding females.
- Patients have hemoglobin values <10 g/dl or platelet values<150,000/ml.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis
Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Intra-articular corticosteroids (IACs) are a frequently-used treatment regimen for pain relief from symptomatic knee OA as it inhibits inflammation and reduces prostaglandin synthesis. Platelet-rich plasma (PRP) is an autologous blood product containing a high percentage of various growth factors (GFs), such as fibroblast growth factor, epidermal growth factor, vascular endothelial growth factor, transforming growth factor-β and platelet-derived growth factor. The aim of this study is to compare effect of intra-articular injection of platelet rich plasma versus corticosteroid in treatment of primary knee osteoarthritis.
- Conditions
- Osteoarthritis Knee, Corticosteroid, Platelet Rich Plasma
- Being tested
- Corticosteroid, 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.
CorticosteroidDrug
The injection will be given at a site near the superolateral pole of patella in the suprapatellar pouch under aseptic conditions and the patient will be advised to take one day of rest after injection and apply ice to the area if there are any signs of inflammation.
Platelet Rich PlasmaOther
PRP preparation :- 20 ml of venous blood will be drawn from the antecubital vein using an 18G needle to avoid traumatizing platelets and will be collected in a sterile tube containing 2 ml of Sodium Citrate anticoagulant. Approximately 2 ml of whole blood will be separated for a complete blood count.The blood with anticoagulant will centrifuged at 4000 rpm for 6-10 minutes to separate erythrocytes and then at 4000 rpm for 6-10 min to concentrate platelets.The final product was 4-5 ml of PRP containing leukocytes with platelet concentration of 3-5 times the average normal value.
| Study group | Role | What they receive |
|---|---|---|
| OA group injected by corticosteroid | Active comparator | Group l include 50 patients who will be injected with one intra_articular injection of 2 ml of methylprednisolone acetate 40 mg/ml mixed with 2ml of lidocaine Receives: Drug: Corticosteroid |
| OA group injected by Platelet Rich Plasma | Active comparator | Group lI include 50 patients who will be injected with a single 5 ml intra_articular injection of PRP prepared in our hospital Receives: Other: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of knee pain, stiffness and physical function prior knee injection
Assessment through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The final score for the WOMAC was determined by adding the aggregate scores for pain, stiffness, and function. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
Measured: Assessment will be done just before injection
Assessment of knee pain, stiffness and physical function 2 weeks after injection
Assessment through WOMAC score
Measured: 2 weeks after injection
Assessment of knee pain, stiffness and physical function 6 weeks after injection
Assessment through WOMAC score
Measured: 6 weeks after injection
Assessment of knee pain, stiffness and physical function 12 weeks after injection
Assessment through WOMAC score
Measured: 12 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study startApr 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis KneeStudies of the same condition, open and under way.
- More trials run by Benha 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa El Sayed Abdel Rahman, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742061
- Sponsor's protocol ID
- MS 54-1-2023
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05742061
- Acronym / sponsor ID
- MS 54-1-2023
- Conditions
- Osteoarthritis Knee, Corticosteroid, Platelet Rich Plasma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Feb 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.
Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Intra-articular corticosteroids (IACs) are a frequently-used treatment regimen for pain relief from symptomatic knee OA as it inhibits inflammation and reduces prostaglandin synthesis. Platelet-rich plasma (PRP) is an autologous blood product containing a high percentage of various growth factors (GFs), such as fibroblast growth factor, epidermal growth factor, vascular endothelial growth factor, transforming growth factor-β and platelet-derived growth factor. The aim of this study is to compare effect of intra-articular injection of platelet rich plasma versus corticosteroid in treatment of primary knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OA group injected by corticosteroid | Active comparator | Drug: CorticosteroidGroup l include 50 patients who will be injected with one intra_articular injection of 2 ml of methylprednisolone acetate 40 mg/ml mixed with 2ml of lidocaine |
| OA group injected by Platelet Rich Plasma | Active comparator | Other: Platelet Rich PlasmaGroup lI include 50 patients who will be injected with a single 5 ml intra_articular injection of PRP prepared in our hospital |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs.
- Patients diagnosed according to ACR classification criteria.
Key exclusion criteria (4 listed)
- Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies.
- Those receiving treatment with anticoagulant , anti_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs.
- Pregnant and breast feeding females.
- Patients have hemoglobin values <10 g/dl or platelet values<150,000/ml.
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 |
|---|---|---|
| CorticosteroidThe injection will be given at a site near the superolateral pole of patella in the suprapatellar pouch under aseptic conditions and the patient will be advised to take one day of rest after injection and apply ice to the area if there are any signs of inflammation. | Drug | OA group injected by corticosteroid |
| Platelet Rich PlasmaPRP preparation :- 20 ml of venous blood will be drawn from the antecubital vein using an 18G needle to avoid traumatizing platelets and will be collected in a sterile tube containing 2 ml of Sodium Citrate anticoagulant. Approximately 2 ml of whole blood will be separated for a complete blood count.The blood with anticoagulant will centrifuged at 4000 rpm for 6-10 minutes to separate erythrocytes and then at 4000 rpm for 6-10 min to concentrate platelets.The final product was 4-5 ml of PRP containing leukocytes with platelet concentration of 3-5 times the average normal value. | Other | OA group injected by Platelet Rich Plasma |
Primary outcome
Assessment of knee pain, stiffness and physical function prior knee injection
Time frame: Assessment will be done just before injection
Assessment through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The final score for the WOMAC was determined by adding the aggregate scores for pain, stiffness, and function. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
Assessment of knee pain, stiffness and physical function 2 weeks after injection
Time frame: 2 weeks after injection
Assessment through WOMAC score
Assessment of knee pain, stiffness and physical function 6 weeks after injection
Time frame: 6 weeks after injection
Assessment through WOMAC score
Assessment of knee pain, stiffness and physical function 12 weeks after injection
Time frame: 12 weeks after injection
Assessment through WOMAC score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Corticosteroid and Platelet Rich Plasma in people with Osteoarthritis Knee and Corticosteroid, run by Benha University.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arwa S. Amer, MD (01550465282, arwa.amer@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of knee pain, stiffness and physical function prior knee injection (time frame: Assessment will be done just before injection). The study lists 4 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 23 Feb 2023.