Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid

Study Overview
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Brief Summary
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To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.

Detailed Description
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To compare the functional outcomes in patients undergoing treatment of knee osteoarthritis using cortisone steroid injections (CSI) or a dehydrated cell and protein concentrate (dCPC) product, Ascent

Official Title
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Randomized Control Study Comparing Efficacy of a Dehydrated Cell and Protein Concentrate (dCPC) (Ascent) Versus Corticosteroid

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Ascent
* Procedure: Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 20 years but less than 75 years old Both male and female (non-pregnant) Valid knee radiograph within 3 months of beginning treatment; Diagnosis of OA of the knee OA pain in the knee despite conservative measures Average daily VAS >= 3 Off any NSAIDs for 1 week prior to injection, may then continue for no more than 5 consecutive days after injection Kellgren-Lawrence system of Grade II, III, or IV Exclusion Criteria: Kellgren-Lawrence Grade I Tense effusion of the knee Significant valgus/varus deformities Viscosupplementation within 6 months Surgery in the knee within the past 6 months Systemic or intraarticular injection of costicosteroids in any joint within 3 months before screening Chronic opioid usage History of Leukemia or Lymphoma History of any autoimmune disorders and disease Immunosuppressive medications Active, suspected, or prior infection to the joint Vulnerable populations (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc...) NSAIDs used within 1 week of the procedure History of bleeding disorders or inflammatory joint disease Patients who plan on becoming pregnant during study period

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ascent Intervention Treatment<br>Interventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection | Procedure: Ascent<br>* Dehydrated Cell and Protein Concentrate injection<br>|
| Active Comparator: Standard Treatment<br>Standard treatment arm will receive a standard Corticosteroid injection | Procedure: Standard<br>* Standard corticosteroid injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring changes in quality of life due to treatment, as assessed by patient reported survey. | The Quality of Life Survey is a patient-reported outcome measure divided into two parts. The first part of the Quality of Life questionnaire/survey will include 4 questions in which patients will be asked to evaluate their individual levels of knee problems (knee difficulty, knee confidence, and lifestyle modifications). Answers will be reported on a 5 point likert scale, in which higher scores indicate more severity, and lower scores indicate less severity. The second part of the questionnaire will include 6 categories (discomfort, mobility, self-care, anxiety, performance of activities, and sleeping). There will be 3 statements per category in which the patient is asked to indicate which statement best describes their current health. The questionnaire is scored by adding up the scores of each item to compute a total score. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measured change in pain: VAS | The Visual Analog scale is a patient-reported outcome measure. It will be presented numerically as an 11 point scale that will ask the patient to rate the severity of their pain on a scale form 0 to 10, which 10 being the most pain imaginable and 0 being the least (no pain). The numerical value will be reported based on the patient's response. The mean pain scores of each intervention group will be calculated. | 12 months |