A Phase 2 interventional study of PRP Treatment and HA Treatment in Knee Osteoarthritis, sponsored by Endeavor Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Endeavor Health · Phase 2, Interventional, and Treatment
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Among 43 studies testing platelet rich plasma in Osteoarthritis, Knee — 3 open to participants now, 4 under way, 1 of them phase 3. platelet rich plasma · Osteoarthritis, Knee.
Among the 43 studies testing platelet rich plasma in Osteoarthritis, Knee, this one is the 12th largest by planned enrollment, is one of 3 that started in 2018, is one of 8 in phase 2, and was the 21st registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.
Browse Osteoarthritis, Knee studies →3 of the 43 studies testing platelet rich plasma in Osteoarthritis, Knee are open now, in 3 countries. Recruiting first, the newest first:
Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz · Sites in Poland
Ages 18–45
University Hospital of North Norway · Sites in Norway
Ages 40–70
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 15 · Phase 3 10 · Phase 4 3
First in 2008; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Median enrollment 60 across the 43 interventional studies. Of the 33 that completed or were terminated, 4 (12%) have results posted.
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1 of 43 have an industry lead sponsor. The 10 most frequent:
Endeavor Health is the lead sponsor of 111 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
Endeavor Health has 3 studies filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
1 of the studies testing platelet rich plasma in Osteoarthritis, Knee that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07473232Pamukkale UniversityComparison of Platelet-rich Plasma and Activated Cytokine-rich Serum Injection Treatments in Patients With Knee Osteoarthritis. (KOA PRP ACS) | 2027-01-18 |
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Among the 43 studies testing platelet rich plasma in Osteoarthritis, Knee, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: PRP Treatment
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.
Biological: HA Treatment
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.
Also known as: Platelet-Rich Plasma
Euflexxa will be used for treatment. It will be prepared according to the package insert.
Also known as: Hyaluronic Acid, Euflexxa
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.
Time frame: 6 and 12 months
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.
Time frame: 6 weeks, 12 weeks, 6 months, and 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2018 (actual). Primary completion is estimated for Dec 2025, 90 months after the start.
Of 43 non-industry phase 2 interventional studies under Osteoarthritis, Knee, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 61. This study's planned 90 months is above that.
Counting every sponsor, half of 101 studies reached it within 20 months; a quarter within 12 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Platelet rich plasma