Knee OsteoarthritisNCT03761472
Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections
A study testing Hyaluronic acid injection and Platelet-rich plasma injection in people with Knee Osteoarthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma injection in terms of pain, physical function and femoral cartilage thickness in short term treatment in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hyaluronic acid injection and Platelet-rich plasma injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 13 Jan 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to consent
- Subject meets Osteoarthritis Research Society International (OARSI) criteria for knee osteoarthritis
- Subject has radiographic Kellgren-Lawrence grade 2-3 osteoarthritis
- Unilateral osteoarthritis/complaint
Who cannot join
- Past or actual knee infection
- History of surgery, fracture on knee
- Collagen tissue disease
- Systemic inflammatory disease (rheumatoid arthritis, spondyloarthritis etc.)
- Systemic diseases (diabetes, hematologic diseases, endocrinopathies, renal failure, liver failure)
- Knee injection in past 6 months
Show all 9Show fewer
- Immunodeficiency
- Pregnant/breastfeeding
- Malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: Comparison of Hyaluronic Acid and Platelet-rich Plasma Injection on Pain, Physical Function and Femoral Cartilage Thickness in Patients With Osteoarthritis
This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma injection in terms of pain, physical function and femoral cartilage thickness in short term treatment in patients with knee osteoarthritis.
Read the detailed description
Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly used for treatment of knee osteoarthritis. Even though there are many studies investigating the effectiveness of these treatments, the results are mostly qualitative. Also there are a few studies comparing these two treatment modalities. In this study the investigators aim to compare these modalities both for self-reported data (pain, physical function) and objective measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be controls for each group.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hyaluronic acid injection, Platelet-rich plasma injection
- Keywords
- Osteoarthritis, Hyaluronic acid, Platelet-rich plasma, Injection
- 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.
Hyaluronic acid injectionBiological
Also called Reviscon Mono
Hyaluronic acid 48 mg 2.0% in 2.4 ml solution
Platelet-rich plasma injectionBiological
Platelet-rich plasma injection 5ml
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid injection | Active comparator | Hyaluronic acid 48 mg 2.0% in 2 ml solution, once initially. Receives: Biological: Hyaluronic acid injection |
| Platelet-rich plasma injection | Active comparator | Platelet-rich plasma 5 ml, once initially Receives: Biological: Platelet-rich plasma injection |
| Unaffected side Hyaluronic acid | No intervention | Unaffected sides of the patients will be controls for hyaluronic acid group, no intervention. |
| Unaffected side Platelet-rich plasma | No intervention | Unaffected sides of the patients will be controls for Platelet-rich plasma group, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of numeric rating scale (rest, movement)
Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
Measured: 0, 1st, 6th, months
Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)
Self reported questionnaire investigating 24 daily living activities. Each item is scored 0-5 (0:none 5:worst). Yielding a total between 0-100. Higher scores represent a worse outcome.
Measured: 0, 1st, 6th months
Change of femoral cartilage thickness via ultrasonography.
Transverse plane femoral cartilage thickness from three landmarks (from articular cartilage pothole,from midpoint of medial border and pothole of cartilage, from midpoint of lateral border and pothole of cartilage). Measured in millimeters. The sum of three points indicate a total thickness. A higher measurement indicates a thicker cartilage representing a better outcome.
Measured: 0, 1st, 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Jan 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
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 Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teoman Aydın, Prof, MD, Study director, Bezmialem Vakif UniversityOzan Volkan Yurdakul, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761472
- Sponsor's protocol ID
- 71306642-050.01.04-
- Status last verified
- Jan 2020
- First submitted
- 23 Nov 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.
PubMed 28146403Keen HI, Hensor EM, Wakefield RJ, Mease PJ, Bingham CO 3rd, Conaghan PG. Ultrasound assessment of response to intra-articular therapy in osteoarthritis of the knee. Rheumatology (Oxford). 2015 Aug;54(8):1385-91. doi: 10.1093/rheumatology/keu529. Epub 2015 Feb 16.
PubMed 25691769
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hyaluronic Acid and Platelet-rich Plasma Injection on Pain, Physical Function and Femoral Cartilage Thickness in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT03761472
- Acronym / sponsor ID
- 71306642-050.01.04-
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Hyaluronic acid, Platelet-rich plasma, Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 3 Dec 2018 (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 study aims to compare the effects of hyaluronic acid injection and platelet rich plasma injection in terms of pain, physical function and femoral cartilage thickness in short term treatment in patients with knee osteoarthritis.
Detailed description
Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly used for treatment of knee osteoarthritis. Even though there are many studies investigating the effectiveness of these treatments, the results are mostly qualitative. Also there are a few studies comparing these two treatment modalities. In this study the investigators aim to compare these modalities both for self-reported data (pain, physical function) and objective measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be controls for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid injection | Active comparator | Biological: Hyaluronic acid injectionHyaluronic acid 48 mg 2.0% in 2 ml solution, once initially. |
| Platelet-rich plasma injection | Active comparator | Biological: Platelet-rich plasma injectionPlatelet-rich plasma 5 ml, once initially |
| Unaffected side Hyaluronic acid | No intervention | –Unaffected sides of the patients will be controls for hyaluronic acid group, no intervention. |
| Unaffected side Platelet-rich plasma | No intervention | –Unaffected sides of the patients will be controls for Platelet-rich plasma group, no intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is able to consent
- Subject meets Osteoarthritis Research Society International (OARSI) criteria for knee osteoarthritis
- Subject has radiographic Kellgren-Lawrence grade 2-3 osteoarthritis
- Unilateral osteoarthritis/complaint
Key exclusion criteria (9 listed)
- Past or actual knee infection
- History of surgery, fracture on knee
- Collagen tissue disease
- Systemic inflammatory disease (rheumatoid arthritis, spondyloarthritis etc.)
- Systemic diseases (diabetes, hematologic diseases, endocrinopathies, renal failure, liver failure)
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 |
|---|---|---|
| Hyaluronic acid injectionAlso: Reviscon MonoHyaluronic acid 48 mg 2.0% in 2.4 ml solution | Biological | Hyaluronic acid injection |
| Platelet-rich plasma injectionPlatelet-rich plasma injection 5ml | Biological | Platelet-rich plasma injection |
Primary outcome
Change of numeric rating scale (rest, movement)
Time frame: 0, 1st, 6th, months
Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)
Time frame: 0, 1st, 6th months
Self reported questionnaire investigating 24 daily living activities. Each item is scored 0-5 (0:none 5:worst). Yielding a total between 0-100. Higher scores represent a worse outcome.
Change of femoral cartilage thickness via ultrasonography.
Time frame: 0, 1st, 6th months
Transverse plane femoral cartilage thickness from three landmarks (from articular cartilage pothole,from midpoint of medial border and pothole of cartilage, from midpoint of lateral border and pothole of cartilage). Measured in millimeters. The sum of three points indicate a total thickness. A higher measurement indicates a thicker cartilage representing a better outcome.
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 Jan 2020.
- Background: PubMed 28146403Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.
- Background: PubMed 25691769Keen HI, Hensor EM, Wakefield RJ, Mease PJ, Bingham CO 3rd, Conaghan PG. Ultrasound assessment of response to intra-articular therapy in osteoarthritis of the knee. Rheumatology (Oxford). 2015 Aug;54(8):1385-91. doi: 10.1093/rheumatology/keu529. Epub 2015 Feb 16.
- 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.
Teoman Aydın, Prof, MD study director
Bezmialem Vakif University
Ozan Volkan Yurdakul, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid injection and Platelet-rich plasma injection in people with Knee Osteoarthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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 Jan 2020. 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 Turkey (Türkiye). 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?
Change of numeric rating scale (rest, movement) (time frame: 0, 1st, 6th, months). 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 NCT03761472, 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 18 Jan 2020.