Knee Osteoarthritis (OA)
Conditions
Keywords
platelet rich plasma, knee OA, PRP, corticosteroids, osteoarthritis, knee osteoarthritis
Brief summary
Prospective, multi-center, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.
Detailed description
Platelet rich plasma has become increasingly utilized as a treatment option for knee osteoarthritis. Corticosteroids is currently an approved medication to treat the symptoms of the knee osteoarthritis. There is limited evidence in a prospective randomized manner powered adequately to determine a difference between these treatments for pain associated with knee osteoarthritis. Prospective, multi-center, single blind (participant), randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.
Interventions
DRUGCorticosteroid Injection
5 milliliters (mL) injection of corticosteroid (1cc Kenalog, 4cc Xylocaine) Kenalog - 40 (triamcinolone acetonide injectable suspension, USP) Xylocaine - MPF (lidocaine HCl Injection, USP)
\ 3 milliliters (mL) injection of autologous PRP Magellan Autologous Concentration System, ISTO Biologics
Sponsors
LifeBridge Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Given the nature of this study, blinding will not be possible for the treating surgeon and research staff. The participants will be blinded from the regimen that they receive, and both groups will have blood drawn and the injection will be covered in a manner to ensure participants cannot ascertain the treatment regimen.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 21-80 years * Radiographic diagnosis of Kellgren-Lawrence (KL) grade of II or III knee osteoarthritis * Indicated for a knee injection to treat knee OA symptoms
Exclusion criteria
* Any injections into the target knee within three months * Current overlying skin infection * Current or previous diagnosis of chronic pain * Opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.) * Allergy to any potential ingredients or medications utilized in any of the two groups * Treatment with another investigational drug or other intervention for pain * Diagnosis of Diabetes Mellitus * If female, pregnant or planning to be pregnant within the following 3 months or study duration * Any condition(s) or diagnosis, both physical or psychological, or physical exam finding in the opinion of the investigator that would precludes participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score VAS | Baseline, six weeks, and three months. | Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Pain intensity that is calculated by measuring the distance from the no pain end of a line to a mark placed by the patient to indicate their current pain level. This will be measured at baseline, six weeks, and three months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score NRS | Baseline, six weeks, and three months. | Numeric Pain Rating Scale (NRPS) where patients are asked to rate their pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. This will be measured at baseline, six weeks, and three months. |
| Functional score KOOS | Baseline, six weeks, and three months. | Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. KOOS is used for any knee pathology and was found to be useful in assessing patients of various age populations, ranging from young to elderly adults. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. This will be measured at baseline, six weeks, and three months. |
| Functional score WOMAC | Baseline, six weeks, and three months. | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright. The total WOMAC score is the sum of the three subscale scores, with a possible score range of 0-96. Higher scores indicate worse pain, stiffness, and functional limitations. This will be measured at baseline, six weeks, and three months. |
| Pain Medication Adherence | Baseline through three months. | Measured by number of days until pain medication (acetaminophen) is not adequate. |
Countries
United States
Outcome results
None listed