OsteoarthritisPhase 3NCT03477630
Treatment of Osteoarthrosis of the Knee With Platelet Rich Plasma, Comparative Study With Hyaluronic Acid
A Phase 3 study testing Platelet Rich Plasma and Hyaluronic Acid in people with Osteoarthritis, run by Karla Andrea Arias Varela at 1 site in Costa Rica.
Trial summary
To compare changes in functionality and pain level using questionnaires EVA, Lequesne and WOMAC in patients treated with 4 doses of 8 ml of autologous Platelet Rich Plasma every 15 days applied through intra-articular infiltration and patients treated with an intra-articular infiltration of 1 dose of SYNVISC-ONE ® 6… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Platelet Rich Plasma and Hyaluronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCosta Rica
- Study dates
- 14 Feb 2019to 16 Sep 2020
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthrosis grade II, III and IV of Kellgren and Lawrence
- Chronic painful knee of mechanical characteristics.
- Absence of local or systemic septic process.
- Hematological and biochemical blood analysis without alterations that contraindicate the treatment.
- Informed consent in writing from the patient.
- Patient able to understand the nature of the study
Who cannot join
- Allergic to egg
- Alteration in blood tests for platelets count in whole blood (hemogram)
- Patients presenting positive serology for HIV 1 and 2, Hepatitis B [HBsAg, Anti-HBV-Ab], Hepatitis C [Anti-HCV-Ab] and VDRL ).
- Participant who presents platelets in the peripheral blood outside the range of normality (150.00 to 450,000).
- Patients with positive serology for HIV 1, and 2, VDRL, Hepatitis B [HBsAg, Anti HBs] Hepatitis C (HCV).
- Simultaneous participation in another clinical trial or treatment with another product in the experimental phase in the 30 days prior to inclusion in the study.
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- Neoplastic disease
- Immunosuppressive states.
- Other pathologies or circumstances that compromise participation in the study according to medical criteria.
- The participant who has received intra-articular injection in knee with steroid deposit in the last 3 months. .
- Participant with religious or cultural conflicts due to the use of Platelet Rich Plasma.
- Participant with an activev infectious diseases in blood.
- Patients with anticoagulant treatment (warfarin, heparin) in the last 6 months.
- Participant with a history of skin, muscle or bone cancer in the lower limbs.
- Participant with psychological, emotional, social problems or any other situation that may interfere with the requirements of the study.
- Participant hospitalized for medical or surgical reasons.
- Participants with an arthroscopy in the last 6 months.
- Participants with severe osteoarthritis of the knee (Varo or Valgo)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Treatment for Pain and Inflammation in Knee Osteoarthrosis With Platelet-rich Plasma, Comparative Study With Hyaluronic Acid
To compare changes in functionality and pain level using questionnaires EVA, Lequesne and WOMAC in patients treated with 4 doses of 8 ml of autologous Platelet Rich Plasma every 15 days applied through intra-articular infiltration and patients treated with an intra-articular infiltration of 1 dose of SYNVISC-ONE ® 6 ml pre-filled syringe, placed according to standard protocol, in patients with OA grade II-IV.
Read the detailed description
28 participants with grade II-IV knee OA who met all the inclusion criteria and none of the exclusion criteria were recruited and selected. They were randomized into two groups, one received 4 doses of PRP and the other conventional hyalurinic acid treatment. Each patient underwent an evaluation of their baseline condition and physical examination of the affected knee by applying the functional and pain level questionnaires: WOMAC, VAS and LEQUESNE, after which each of the treatments was applied, respectively. The control group received 1 dose of SYNVISC-ONE, placed according to the standard intra-articular infiltration protocol, and group 2 received 4 intra-articular infiltrations of activated autologous PRP placed every 15 days. The patients were assessed at 3, 6 and 12 months by physical examination and the same surveys were applied to determine the progress and efficacy of the treatments using the same surveys. Finally, a statistical analysis was performed to compare the results between the two treatments.
- Conditions
- Osteoarthritis
- Being tested
- Platelet Rich Plasma, Hyaluronic Acid
- Keywords
- gonarthrosis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Also called PRP
intra-articular infiltration of 8 ml of autologous PRP every 15 days.
Hyaluronic AcidDrug
Also called HA
intra-articular infiltration of a single dose of HA
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma | Experimental | Four intra-articular infiltration of autologous PRP every 15 days. Receives: Biological: Platelet Rich Plasma |
| Hyaluronic Acid | Active comparator | One intra-articular infiltration of SYNVISC-ONE Receives: Drug: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain levels and functionality
Eva scale for the intensity of pain associated with activities of daily living and if sports activities are practiced. Lequesne index for knee osteoarthritis and physical function, pain and stiffness measured by Womac index.Each of the 3 questionnaires was evaluated at four different times: baseline, 3 months, 6 months and 12 months after treatment.
Measured: Baseline, 3 months, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start14 Feb 2019
- Primary completion25 Jul 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open, cohort, prospective controlled, randomized study with one year of follow-up.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karla Andrea Arias Varela
- Responsible party
- Sponsor-investigator, Karla Andrea Arias Varela, Varela, Karla Andrea Arias, M.D.
- Investigators
- Carlos Palavicini, Study director, FIFA MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477630
- Sponsor's protocol ID
- PRP 3.5 - 01 version 1.3
- Status last verified
- Jun 2022
- First submitted
- 12 Mar 2018
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riboh JC, Saltzman BM, Yanke AB, Fortier L, Cole BJ. Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. Am J Sports Med. 2016 Mar;44(3):792-800. doi: 10.1177/0363546515580787. Epub 2015 Apr 29.
PubMed 25925602Carrillo-Mora P, Gonzalez-Villalva A, Macias-Hernandez SI, Villasenor CP. [Platelets-rich plasma: a versatile tool for regenerative medicine?]. Cir Cir. 2013 Jan-Feb;81(1):74-82. Spanish.
PubMed 23461926Shahid M, Kundra R. Platelet-rich plasma (PRP) for knee disorders. EFORT Open Rev. 2017 Mar 13;2(1):28-34. doi: 10.1302/2058-5241.2.160004. eCollection 2017 Jan.
PubMed 28607768Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015.
PubMed 25624776
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Treatment for Pain and Inflammation in Knee Osteoarthrosis With Platelet-rich Plasma, Comparative Study With Hyaluronic Acid
- ClinicalTrials.gov ID
- NCT03477630
- Acronym / sponsor ID
- PRP 3.5 - 01 version 1.3
- Conditions
- Osteoarthritis
- Keywords
- gonarthrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Karla Andrea Arias Varela
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 26 Mar 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.
To compare changes in functionality and pain level using questionnaires EVA, Lequesne and WOMAC in patients treated with 4 doses of 8 ml of autologous Platelet Rich Plasma every 15 days applied through intra-articular infiltration and patients treated with an intra-articular infiltration of 1 dose of SYNVISC-ONE ® 6 ml pre-filled syringe, placed according to standard protocol, in patients with OA grade II-IV.
Detailed description
28 participants with grade II-IV knee OA who met all the inclusion criteria and none of the exclusion criteria were recruited and selected. They were randomized into two groups, one received 4 doses of PRP and the other conventional hyalurinic acid treatment. Each patient underwent an evaluation of their baseline condition and physical examination of the affected knee by applying the functional and pain level questionnaires: WOMAC, VAS and LEQUESNE, after which each of the treatments was applied, respectively. The control group received 1 dose of SYNVISC-ONE, placed according to the standard intra-articular infiltration protocol, and group 2 received 4 intra-articular infiltrations of activated autologous PRP placed every 15 days. The patients were assessed at 3, 6 and 12 months by physical examination and the same surveys were applied to determine the progress and efficacy of the treatments using the same surveys. Finally, a statistical analysis was performed to compare the results between the two treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open, cohort, prospective controlled, randomized study with one year of follow-up.
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma | Experimental | Biological: Platelet Rich PlasmaFour intra-articular infiltration of autologous PRP every 15 days. |
| Hyaluronic Acid | Active comparator | Drug: Hyaluronic AcidOne intra-articular infiltration of SYNVISC-ONE |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Osteoarthrosis grade II, III and IV of Kellgren and Lawrence
- Chronic painful knee of mechanical characteristics.
- Absence of local or systemic septic process.
- Hematological and biochemical blood analysis without alterations that contraindicate the treatment.
- Informed consent in writing from the patient.
Key exclusion criteria (18 listed)
- Allergic to egg
- Alteration in blood tests for platelets count in whole blood (hemogram)
- Patients presenting positive serology for HIV 1 and 2, Hepatitis B [HBsAg, Anti-HBV-Ab], Hepatitis C [Anti-HCV-Ab] and VDRL ).
- Participant who presents platelets in the peripheral blood outside the range of normality (150.00 to 450,000).
- Patients with positive serology for HIV 1, and 2, VDRL, Hepatitis B [HBsAg, Anti HBs] Hepatitis C (HCV).
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 PlasmaAlso: PRPintra-articular infiltration of 8 ml of autologous PRP every 15 days. | Biological | Platelet Rich Plasma |
| Hyaluronic AcidAlso: HAintra-articular infiltration of a single dose of HA | Drug | Hyaluronic Acid |
Primary outcome
Changes in pain levels and functionality
Time frame: Baseline, 3 months, 6 months and 12 months.
Eva scale for the intensity of pain associated with activities of daily living and if sports activities are practiced. Lequesne index for knee osteoarthritis and physical function, pain and stiffness measured by Womac index.Each of the 3 questionnaires was evaluated at four different times: baseline, 3 months, 6 months and 12 months after treatment.
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 16 Jun 2022.
- Background: PubMed 25925602Riboh JC, Saltzman BM, Yanke AB, Fortier L, Cole BJ. Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. Am J Sports Med. 2016 Mar;44(3):792-800. doi: 10.1177/0363546515580787. Epub 2015 Apr 29.
- Background: PubMed 23461926Carrillo-Mora P, Gonzalez-Villalva A, Macias-Hernandez SI, Villasenor CP. [Platelets-rich plasma: a versatile tool for regenerative medicine?]. Cir Cir. 2013 Jan-Feb;81(1):74-82. Spanish.
- Background: PubMed 28607768Shahid M, Kundra R. Platelet-rich plasma (PRP) for knee disorders. EFORT Open Rev. 2017 Mar 13;2(1):28-34. doi: 10.1302/2058-5241.2.160004. eCollection 2017 Jan.
- Results publication: PubMed 25624776Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015.
- 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.
Carlos Palavicini study director
FIFA MD
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 and Hyaluronic Acid in people with Osteoarthritis, run by Karla Andrea Arias Varela at 1 site in Costa Rica.
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 6 inclusion and 18 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 16 Jun 2022. 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 Costa Rica. 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?
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?
Changes in pain levels and functionality (time frame: Baseline, 3 months, 6 months and 12 months.). 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 NCT03477630, which also lists 4 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 16 Jun 2022.