Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid
- Conditions
- Knee Osteoarthritis
- Interventions
- Procedure: AscentProcedure: Standard
- Registration Number
- NCT03710005
- Lead Sponsor
- StimLabs
- Brief Summary
To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.
- Detailed Description
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 51
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ascent Intervention Treatment Ascent Interventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection Standard Treatment Standard Standard treatment arm will receive a standard Corticosteroid injection
- Primary Outcome Measures
Name Time Method Measuring changes in quality of life due to treatment, as assessed by patient reported survey. 12 months 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.
- Secondary Outcome Measures
Name Time Method Measured change in pain: VAS 12 months 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.
Trial Locations
- Locations (4)
Emory At Dunwoody
🇺🇸Dunwoody, Georgia, United States
Emory at Smyrna
🇺🇸Smyrna, Georgia, United States
Emory Sports Medicine Complex
🇺🇸Brookhaven, Georgia, United States
Emory Orthopaedics and Spine Center
🇺🇸Johns Creek, Georgia, United States