Knee OsteoarthritisEarly Phase 1NCT06797960
Ultrasound Guided Intra Articular Injection of Platelet Rich Fibrin Versus Hyaluronic Acid As Means of Pain Relief in Patients with Moderate Degree Knee Osteoarthritis
A Early Phase 1 study testing Ultra sound guided Injection of PRF intra articularly and Intra articular injection of HA in people with Knee Osteoarthritis, run by Fayoum University.
Trial summary
Randomised controlled trial Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ultra sound guided Injection of PRF intra articularly and Intra articular injection of HA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to Sep 2025
- Phase
- Early Phase 1
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I, II.
- Moderate knee osteoarthritis
Who cannot join
- Neurological patients.
- Patients with uncontrolled co morbidities
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Islam Shaban Shaban contact
About this study
Official title: ANALGESIC EFFECT of ULTRASOUND GUIDED INTRA- ARTICULAR INJECTION of PLATELET RICH FIBRIN VERSUS INJECTION of HYALURONIC ACID in PATIENTS with MODERATE KNEE OSTEOARTHRITIS. a RANDOMIZED CONTROLLED STUDY
Randomised controlled trial
- Conditions
- Knee Osteoarthritis
- Being tested
- Ultra sound guided Injection of PRF intra articularly, Intra articular injection of HA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra sound guided Injection of PRF intra articularlyDevice
Intra articular injection of PRF
Intra articular injection of HADrug
Intra articular injection of HA
| Study group | Role | What they receive |
|---|---|---|
| PRF group | Active comparator | Not described Receives: Device: Ultra sound guided Injection of PRF intra articularly |
| Hyaluronic acid group | Active comparator | Not described Receives: Drug: Intra articular injection of HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief as measured by VAS score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completionSep 2025 (estimated)
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 Fayoum 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Shaban Shaban, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797960
- Sponsor's protocol ID
- M757
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANALGESIC EFFECT of ULTRASOUND GUIDED INTRA- ARTICULAR INJECTION of PLATELET RICH FIBRIN VERSUS INJECTION of HYALURONIC ACID in PATIENTS with MODERATE KNEE OSTEOARTHRITIS. a RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT06797960
- Acronym / sponsor ID
- M757
- Conditions
- Knee Osteoarthritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 29 Jan 2025 (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.
Randomised controlled trial
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF group | Active comparator | Device: Ultra sound guided Injection of PRF intra articularly |
| Hyaluronic acid group | Active comparator | Drug: Intra articular injection of HA |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I, II.
- Moderate knee osteoarthritis
Key exclusion criteria (2 listed)
- Neurological patients.
- Patients with uncontrolled co morbidities
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 |
|---|---|---|
| Ultra sound guided Injection of PRF intra articularlyIntra articular injection of PRF | Device | PRF group |
| Intra articular injection of HAIntra articular injection of HA | Drug | Hyaluronic acid group |
Primary outcome
Pain relief as measured by VAS score
Time frame: 3 months
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 29 Jan 2025.
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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.
Islam Shaban Shaban contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ultra sound guided Injection of PRF intra articularly and Intra articular injection of HA in people with Knee Osteoarthritis, run by Fayoum 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 2 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: opening soon, as of the sponsor's last update on 29 Jan 2025. 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?
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 Islam Shaban Shaban (00201008757498), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief as measured by VAS score (time frame: 3 months). 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 29 Jan 2025.