Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis
NCT ID: NCT03491761
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2018-06-13
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PRP Treatment
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.
PRP 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.
HA 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.
HA Treatment
Euflexxa will be used for treatment. It will be prepared according to the package insert.
Interventions
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PRP 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.
HA Treatment
Euflexxa will be used for treatment. It will be prepared according to the package insert.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Surgery on target knee within 12 months prior to scheduled treatment
* Autoimmune disorder
* Active infections
* Immuno-suppression (e.g., AIDS, etc.)
* Anti-coagulant therapy
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Endeavor Health
OTHER
Responsible Party
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Jason Koh
Board of Directors Endowed Chair of Orthopaedic Surgery
Principal Investigators
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Jason L Koh, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Clinical Chairman, Dept. of Orthopaedics
Locations
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NorthShore University HealthSystems
Skokie, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EH17-199
Identifier Type: -
Identifier Source: org_study_id
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