Osteoarthritis, KneePhase 3NCT04980105
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis
A Phase 3 study testing Platelet-rich plasma, Hyaluronic acid and Methylprednisolone acetate injectable suspension (DEPO-MEDROL®) in people with Osteoarthritis, Knee, run by University of Wasit at 1 site in Iraq.
Trial summary
To assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Platelet-rich plasma, Hyaluronic acid and Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIraq
- Study dates
- 2 Mar 2020to 1 Oct 2021
- Phase
- Phase 3
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 35-65 years old
- Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inflammatory medications and that deteriorated with weight-bearing
- Knee osteoarthritis that classified as mild-moderate or moderate-severe (Kellgren-Lawrence Grade 2, 3, or 4)
Who cannot join
- Age > 65 years
- The recent history of knee trauma
- Autoimmune rheumatic diseases
- Accompanying severe hip OA
- Thrombocytopenia or other blood diseases
- Immunosuppressive or anticoagulant treatment
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- The invasive procedure applied to the knee
- Intra-articular steroid injection to the knee within the previous 12 months
- Previous joint infection
- Uncontrolled systemic diseases such as diabetes or hypertension, and cancer
- Excessive varus/valgus knee deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population
To assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Platelet-rich plasma, Hyaluronic acid, Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaBiological
Two intra-articular injections of autologous platelets-rich plasma (PRP) in two weeks intervals between the first and the second injection.
Hyaluronic acidDrug
Two intraarticular injections of hyaluronic acid (60 mg) in two weeks intervals between the first and the second injection
Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)Drug
Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration)
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich plasma arm | Experimental | Not described Receives: Biological: Platelet-rich plasma |
| Hyaluronic acid arm | Active comparator | Not described Receives: Drug: Hyaluronic acid |
| Methylprednisolone acetate arm | Active comparator | Not described Receives: Drug: Methylprednisolone acetate injectable suspension (DEPO-MEDROL®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go test (TUG)
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees
Measured: 18th months
Visual Analogue Scale (VAS)
The VAS uses a straight 10 centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level
Measured: 18th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start2 Mar 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 150 participants fulfilling the inclusion criteria, patients were randomly assigned into three groups by a computer-based protocol. The patients were separated into three groups according to the type of treatment administered.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wasit
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usama Al-Sari, University of Wasit
- Investigators
- Usama A Al-Sari, PhD, Principal investigator, UOW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980105
- Sponsor's protocol ID
- UOW/MS102
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population
- ClinicalTrials.gov ID
- NCT04980105
- Acronym / sponsor ID
- UOW/MS102
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of WasitUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 28 Jul 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.
To assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A total of 150 participants fulfilling the inclusion criteria, patients were randomly assigned into three groups by a computer-based protocol. The patients were separated into three groups according to the type of treatment administered.
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma arm | Experimental | Biological: Platelet-rich plasma |
| Hyaluronic acid arm | Active comparator | Drug: Hyaluronic acid |
| Methylprednisolone acetate arm | Active comparator | Drug: Methylprednisolone acetate injectable suspension (DEPO-MEDROL®) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 35-65 years old
- Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inflammatory medications and that deteriorated with weight-bearing
- Knee osteoarthritis that classified as mild-moderate or moderate-severe (Kellgren-Lawrence Grade 2, 3, or 4)
Key exclusion criteria (11 listed)
- Age > 65 years
- The recent history of knee trauma
- Autoimmune rheumatic diseases
- Accompanying severe hip OA
- Thrombocytopenia or other blood diseases
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 plasmaTwo intra-articular injections of autologous platelets-rich plasma (PRP) in two weeks intervals between the first and the second injection. | Biological | Platelet-rich plasma arm |
| Hyaluronic acidTwo intraarticular injections of hyaluronic acid (60 mg) in two weeks intervals between the first and the second injection | Drug | Hyaluronic acid arm |
| Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration) | Drug | Methylprednisolone acetate arm |
Primary outcome
Timed Up and Go test (TUG)
Time frame: 18th months
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees
Visual Analogue Scale (VAS)
Time frame: 18th months
The VAS uses a straight 10 centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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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.
Usama A Al-Sari, PhD principal investigator
UOW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet-rich plasma, Hyaluronic acid and Methylprednisolone acetate injectable suspension (DEPO-MEDROL®) in people with Osteoarthritis, Knee, run by University of Wasit at 1 site in Iraq.
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 11 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 28 Jul 2021. 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 Iraq. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Timed Up and Go test (TUG) (time frame: 18th 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 28 Jul 2021.