Knee OsteoarthritisPhase 2NCT03491761
Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis
A Phase 2 study testing PRP Treatment and HA Treatment in people with Knee Osteoarthritis, run by Endeavor Health at 1 site in United States.
Trial summary
This is a single-center, prospective, randomized, single-blind, comparator therapy, parallel group study for symptomatic patients diagnosed with knee osteoarthritis. The aim is to demonstrate superior efficacy of platelet-rich plasma (PRP) as compared to hyaluronic acid (HA) in treating knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PRP Treatment and HA Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to Dec 2027
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent
- Chronic pain (>3 months)
- Grade 2 -3 according to Kellgren- Lawrence (K-L) classification system (using bilateral anteroposterior radiograph image acquired while the patient is weight-bearing with both knees in full extension)
- Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain
- Age 18 to 75 years old
- Physical exam and medical history
Show all 10Show fewer
- Complete Blood Count to include platelets and differential (CBC with Diff) within normal limits
- C-Reactive Protein (CRP) within normal limits
- Sed Rate (ESR) within normal limits
- Survey of current medications
Who cannot join
- Presence of major axial deformity (>5° valgus or varus deviation)
- Surgery on target knee within 12 months prior to scheduled treatment
- Autoimmune disorder
- Active infections
- Immuno-suppression (e.g., AIDS, etc.)
- Anti-coagulant therapy
Show all 20Show fewer
- Use of NSAIDs 5 days prior to blood draw or up to 7 days after last PRP / HA treatment
- Hemoglobin (Hg) <12 g/dL
- Platelet counts (PLT) <150,000 /mm3
- Previous infiltrative treatment within 3 weeks prior to scheduled treatment
- Pregnancy/Breastfeeding
- Hypersensitivity to HA
- Inability to complete an MRI due to metal implants or claustrophobia
- Diabetes
- Active treatment for a malignancy
- Active wound in the knee
- Recent history of knee trauma
- Vasovagal history
- An injection of hyaluronic acid (HA) or platelet-rich plasma (PRP) to the affected knee within the last two years.
- In the judgment of the investigator, the patient is unable to perform and/or complete all of the study visits or treatments required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NorthShore University HealthSystems
Skokie, Illinois, 60076
Jason L Koh, MD, MBA, 847-866-7846, jkoh@northshore.org
Jason L Koh, MD, MBA
About this study
Official title: Does Intra-articular Platelet-Rich Plasma Injection Provide Superior Outcomes Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis?
This is a single-center, prospective, randomized, single-blind, comparator therapy, parallel group study for symptomatic patients diagnosed with knee osteoarthritis. The aim is to demonstrate superior efficacy of platelet-rich plasma (PRP) as compared to hyaluronic acid (HA) in treating knee osteoarthritis. This aim will be objectively measured by endpoint consisting of changes in cartilage thickness from baseline in the MRI. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire will be used to calculate The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. It will measure changes in pain and function from baseline. Approximately 100 subjects will be treated at NorthShore University HealthSystem (NorthShore) as part of this study. This study has the potential to improve outcomes in a very common chronic degenerative disease, osteoarthritis, which can have a significant effect on individuals' quality of life.
Read the detailed description
This is a prospective, randomized, single-blind, comparative clinical trial with an allocation ratio of 1:1. The primary endpoint is the MRI-based cartilage thickness measurement. The secondary endpoint is the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. There are 2 arms: PRP treatment and HA treatment. Due to the treatment procedure, the study will not be blinded to either the subject or PI. However, the radiologist that scores the cartilage thickness will be blinded with regard to clinical characteristics and treatment of subjects.
The subjects are randomized with 1:1 block randomization with a block size of 4 patients. The patient population is symptomatic patients diagnosed with knee osteoarthritis K-L grade 2 or 3. The sample size is 100 total subjects (50 in each arm). The duration is approximately 13 months, final data accumulated at month 12 after treatment at single site - NorthShore.
All potential subjects will complete screening blood work which will consist of a complete blood count to include platelets and differential (CBC with Diff), c-reactive protein (CRP), and a sed rate (ESR).
Patients randomized into the PRP group will also have at the time of the procedure whole blood and PRP analyzed for PLT, WBC, and RBC per injection, and a CBC with leukocyte differential will be performed on the PRP to evaluate the fold increase in platelet concentrations. The amount of blood taken for the procedure will be approximately 15 ml (3-4 teaspoons). Four to six milliliters are injected back into the knee as plasma rich platelets.
Patients randomized to the HA group will not undergo any laboratory testing.
Data will be summarized as mean±sd for continuous variables and frequencies and percentages for categorical variables. For the primary analysis, repeated measures ANOVA will be performed on both primary and secondary endpoints using baseline and 12 months data to examine the differences in changes between PRP and HA groups. In addition, linear mixed models will be used to analyze WOMAC scores (baseline, 1m, 3m, 6m, and 12m) and MRI data (baseline, 6m, 12m) using all available data collected from all time points. All analysis will be performed with SAS 9.3 (SAS Inc., Cary, NC). A p value <0.05 will be considered statistically significant.
- Conditions
- Knee Osteoarthritis
- Being tested
- PRP Treatment, HA Treatment
- Keywords
- Platelet Rich Plasma (PRP), Viscosupplementation, Knee Osteoarthritis, Hyaluronic Acid (HA), WOMAC, KOOS, Euflexxa
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP TreatmentBiological
Also called Platelet-Rich Plasma
PRP will be prepared using an Arthrex ACP® kit (a low-leukocyte Autologous Conditioned Plasma system). This is a single-spin system that concentrates platelets and separates red blood cells (RBCs) as well as white blood cells (WBCs) from the treatment product.
HA TreatmentBiological
Also called Hyaluronic Acid, Euflexxa
Euflexxa will be used for treatment. It will be prepared according to the package insert.
| Study group | Role | What they receive |
|---|---|---|
| PRP Treatment | Experimental | PRP is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. The PRP is obtained from a maximum 16 cc sample of the patients' blood drawn at the time of treatment. Using sterile technique, the venous blood is transferred to a centrifuge and prepared by the centrifugation process for 5 minutes. 4-7 mL of PRP is transferred from the large outer syringe into the small inner syringe and injected within 30 minutes of being spun to negate the need of anticoagulants. The procedure will take approximately 20-30 minutes. Receives: Biological: PRP Treatment |
| HA Treatment | Active comparator | HA is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. Euflexxa will be prepared according to the package insert. Receives: Biological: HA Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cartilage Thickness on MRI
Evaluation of changes from baseline in central medial femorotibial compartment cartilage thickness measurements (via ordered value method) using quantitative T1 and cartilage compositional changes using T2 MRI at 6 and 12 months.
Measured: 6 and 12 months
Secondary outcomes (1)
3. A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score)
The KOOS is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score will be calculated using KOOS Questionnaire. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total WOMAC score is created by summing the items for all three subscales, with higher scores reflecting worse pain, stiffness, and physical function. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
This objective will be measured in WOMAC total score from baseline to 6 weeks, 12 weeks, 6 months, and 12 months in 100 subjects.
Measured: 6 weeks, 12 weeks, 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 posted9 Apr 2018
- Study start13 Jun 2018
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Koh, Endeavor Health
- Investigators
- Jason L Koh, MD, MBA, Principal investigator, Clinical Chairman, Dept. of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491761
- Sponsor's protocol ID
- EH17-199
- Status last verified
- Feb 2024
- First submitted
- 2 Apr 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intra-articular Platelet-Rich Plasma Injection Provide Superior Outcomes Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis?
- ClinicalTrials.gov ID
- NCT03491761
- Acronym / sponsor ID
- EH17-199
- Conditions
- Knee Osteoarthritis
- Keywords
- Platelet Rich Plasma (PRP), Viscosupplementation, Knee Osteoarthritis, Hyaluronic Acid (HA), WOMAC, KOOS, Euflexxa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Apr 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 is a single-center, prospective, randomized, single-blind, comparator therapy, parallel group study for symptomatic patients diagnosed with knee osteoarthritis. The aim is to demonstrate superior efficacy of platelet-rich plasma (PRP) as compared to hyaluronic acid (HA) in treating knee osteoarthritis. This aim will be objectively measured by endpoint consisting of changes in cartilage thickness from baseline in the MRI. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire will be used to calculate The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. It will measure changes in pain and function from baseline. Approximately 100 subjects will be treated at NorthShore University HealthSystem (NorthShore) as part of this study. This study has the potential to improve outcomes in a very common chronic degenerative disease, osteoarthritis, which can have a significant effect on individuals' quality of life.
Detailed description
This is a prospective, randomized, single-blind, comparative clinical trial with an allocation ratio of 1:1. The primary endpoint is the MRI-based cartilage thickness measurement. The secondary endpoint is the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. There are 2 arms: PRP treatment and HA treatment. Due to the treatment procedure, the study will not be blinded to either the subject or PI. However, the radiologist that scores the cartilage thickness will be blinded with regard to clinical characteristics and treatment of subjects.
The subjects are randomized with 1:1 block randomization with a block size of 4 patients. The patient population is symptomatic patients diagnosed with knee osteoarthritis K-L grade 2 or 3. The sample size is 100 total subjects (50 in each arm). The duration is approximately 13 months, final data accumulated at month 12 after treatment at single site - NorthShore.
All potential subjects will complete screening blood work which will consist of a complete blood count to include platelets and differential (CBC with Diff), c-reactive protein (CRP), and a sed rate (ESR).
Patients randomized into the PRP group will also have at the time of the procedure whole blood and PRP analyzed for PLT, WBC, and RBC per injection, and a CBC with leukocyte differential will be performed on the PRP to evaluate the fold increase in platelet concentrations. The amount of blood taken for the procedure will be approximately 15 ml (3-4 teaspoons). Four to six milliliters are injected back into the knee as plasma rich platelets.
Patients randomized to the HA group will not undergo any laboratory testing.
Data will be summarized as mean±sd for continuous variables and frequencies and percentages for categorical variables. For the primary analysis, repeated measures ANOVA will be performed on both primary and secondary endpoints using baseline and 12 months data to examine the differences in changes between PRP and HA groups. In addition, linear mixed models will be used to analyze WOMAC scores (baseline, 1m, 3m, 6m, and 12m) and MRI data (baseline, 6m, 12m) using all available data collected from all time points. All analysis will be performed with SAS 9.3 (SAS Inc., Cary, NC). A p value <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Treatment | Experimental | Biological: PRP TreatmentPRP is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. The PRP is obtained from a maximum 16 cc sample of the patients' blood drawn at the time of treatment. Using sterile technique, the venous blood is transferred to a centrifuge and prepared by the centrifugation process for 5 minutes. 4-7 mL of PRP is transferred from the large outer syringe into the small inner syringe and injected within 30 minutes of being spun to negate the need of anticoagulants. The procedure will take approximately 20-30 minutes. |
| HA Treatment | Active comparator | Biological: HA TreatmentHA is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. Euflexxa will be prepared according to the package insert. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to provide informed consent
- Chronic pain (>3 months)
- Grade 2 -3 according to Kellgren- Lawrence (K-L) classification system (using bilateral anteroposterior radiograph image acquired while the patient is weight-bearing with both knees in full extension)
- Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain
- Age 18 to 75 years old
Key exclusion criteria (20 listed)
- Presence of major axial deformity (>5° valgus or varus deviation)
- Surgery on target knee within 12 months prior to scheduled treatment
- Autoimmune disorder
- Active infections
- Immuno-suppression (e.g., AIDS, etc.)
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 |
|---|---|---|
| PRP TreatmentAlso: Platelet-Rich PlasmaPRP will be prepared using an Arthrex ACP® kit (a low-leukocyte Autologous Conditioned Plasma system). This is a single-spin system that concentrates platelets and separates red blood cells (RBCs) as well as white blood cells (WBCs) from the treatment product. | Biological | PRP Treatment |
| HA TreatmentAlso: Hyaluronic Acid, EuflexxaEuflexxa will be used for treatment. It will be prepared according to the package insert. | Biological | HA Treatment |
Primary outcome
Cartilage Thickness on MRI
Time frame: 6 and 12 months
Evaluation of changes from baseline in central medial femorotibial compartment cartilage thickness measurements (via ordered value method) using quantitative T1 and cartilage compositional changes using T2 MRI at 6 and 12 months.
1 secondary outcome
3. A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score)
Time frame: 6 weeks, 12 weeks, 6 months, and 12 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 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jason L Koh, MD, MBA principal investigator
Clinical Chairman, Dept. of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRP Treatment and HA Treatment in people with Knee Osteoarthritis, run by Endeavor Health at 1 site in United States.
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 10 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 28 Feb 2024. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jason L Koh, MD, MBA (224-251-3481, jkoh@northshore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cartilage Thickness on MRI (time frame: 6 and 12 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 28 Feb 2024.