Osteoarthritis (OA), Osteoarthritis (OA) of the Knee, Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Shoulder, Osteoarthritis Ankle, Elbow Osteoarthritis, Epicondylitis of the Elbow, Plantar Fasciitis of Both Feet, Tendinopathy
Conditions
Keywords
PRP, Platelet Rich Plasma, Osteoarthritis, Tendinopathy
Brief summary
The primary purpose of this study is to follow patients with various musculoskeletal (MSK) conditions over a one-year follow-up period after receiving a platelet rich plasma (PRP) injection, assessing changes in their pain levels, functional abilities, and overall patient satisfaction. This will develop a robust registry of patients treated with PRP for a range of MSK conditions. These conditions include, but are not limited to, osteoarthritis (OA) of the knee, hip, glenohumeral joint, elbow, ankle, and sacroiliac joint, as well as rotator cuff tendinopathy, lateral and medial epicondylitis, plantar fasciitis, patellar tendinopathy, Achilles tendinopathy, and proximal hamstring tendinopathy.
Detailed description
Platelet-Rich Plasma (PRP) is an injectable preparation of a patient's blood that can be used for numerous conditions and has received significant attention over the past several years for its potential application for the treatment of pain and functional impairment due to osteoarthritis (OA) and other musculoskeletal conditions. Research on PRP has expanded dramatically over the last several decades, elevating its status from snake oil to a proven injection option superior to corticosteroids. It has demonstrated superior efficacy to standard-of-care corticosteroids in numerous musculoskeletal conditions. Systematic reviews of randomized-controlled trials have demonstrated equivalent-to-superior treatment outcomes associated with the use of intra-articular PRP compared to placebo, hyaluronic acid, and corticosteroid for the most commonly-studied condition, knee OA. Most importantly, just as corticosteroids have been used in numerous musculoskeletal conditions (OA, tendinopathy, bursitis, etc.), PRP has the same potential, but with vastly reduced risk; corticosteroids have many known dangers. To summarize, PRP has demonstrated level 1 evidence of superiority to corticosteroids in pain and function in numerous musculoskeletal conditions, with considerably less risk. This study will evaluate pain, function, and overall patient satisfaction outcomes for the use of PRP for the treatment of a diverse MSK conditions, including, but not limited to, OA of the knee, hip, glenohumeral joint, elbow, ankle, and sacroiliac joint, as well as rotator cuff tendinopathy, lateral and medial epicondylitis, plantar fasciitis, patellar tendinopathy, Achilles tendinopathy, and proximal hamstring tendinopathy.
Interventions
BIOLOGICALPlatelet Rich Plasma Injection
Participants who are eligible and provide consent to participate will undergo a Platelet-Rich Plasma (PRP) injection. Their blood will be analyzed using a cell counter, and they will be asked to complete follow-up surveys at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
DEVICEPlatelet Rich Plasma Preparation
The patient's blood is collected into syringes. That blood is spun in a centrifuge at high speeds, which separates their blood into layers (red blood cells, white blood cells, and plasma). The plasma portion, which contains the platelets, is transferred to a different syringe for later injection. In some cases, the plasma is spun in the centrifuge again (a "double spin" technique) to further concentrate the platelets in the plasma. The patient's blood is not exposed to air, and it is transferred by tubing between syringes with a Luer Lock connection.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18+ years old * Musculoskeletal pathology that may benefit from a PRP injection * Failed other conservative treatments
Exclusion criteria
* No active malignancy * No active infection in the area of injection * No platelet disorder * No active systemic infections * No patients currently undergoing dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog score (pain) | 6 months | The VAS is a 0 to 10 scale, with zero being no pain and ten being the worst pain imaginable for their condition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score (pain) | 1, 3, and 12 months | The VAS is a 0 to 10 scale, with zero being no pain and ten being the worst pain imaginable for their condition |
| Global satisfaction | 1, 3, 6, 12 months | From a scale of 0 to 100, the subject assesses their total satisfaction with the affected body part. Zero is no satisfaction, while 100 is complete satisfaction. |
| Western Ontario and McMaster Universities Arthritis Index (knee) | 1, 3, 6, 12 months | The WOMAC is a self-administered questionnaire used to evaluate pain, stiffness, and physical function in people with hip and knee osteoarthritis. Only for patients with knee OA. WOMAC scoring involves summing the scores from its three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each subscale has a maximum score (Pain: 20, Stiffness: 8, Physical Function: 68), and a total WOMAC score is calculated by adding these three sub-scores together, for a possible total range of 0-96. Higher scores indicate worse symptoms and function. |
| Disorders of the Arm, Shoulder, and Hand (QuickDASH) | 1, 3, 6, 12 months | The QuickDASH an 11-item patient-reported questionnaire used to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb (arm, shoulder, and hand). To score the QuickDASH, the first sum is the scores from the 11 items, each rated on a 1-5 Likert scale. The sum is then used in the formula: QuickDASH Score = (\[(sum of n responses)/n\]-1)\*25), where (n) is the number of completed items. A minimum of 10 out of 11 items must be completed to calculate a score, and the final score ranges from 0 (no disability) to 100 (most severe disability). |
| International Hip Outcome Tool 12 (IHOT12) | 1, 3, 6, 12 months | This is a 12-item patient-reported outcome measure (PROM) used to assess the health-related quality of life in young, active patients with hip problems. Each question is scored from 0 (worst symptoms/function) to 100 (best symptoms/function). The scores are averaged from all questions, and the final score ranges from 0 (worst symptoms/function) to 100 (best symptoms/function). |
| Foot and Ankle Outcome Score (FAOS) | 1, 3, 6, 12 months | The FAOS is a patient-reported questionnaire that measures a person's foot and ankle symptoms and functional status. It is divided into five subscales: pain, other symptoms, function in daily living, function in sports and recreation, and quality of life. Scores for each subscale range from 0 to 100, where 100 represents no symptoms and 0 indicates the worst possible symptoms. |
| EQ-5D | 1, 3, 6, 12 months | The EQ-5D is a self-report questionnaire that measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It consists of two parts of the EURO-QOL. The first is an index score, calculated from a 5-digit health state code that corresponds to a person's self-reported level of problems in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). It is calculated by applying a formula to the 5-digit descriptive system code (e.g., 11111 for no problems). This formula uses "social preference weights" for each level in each dimension. A score of 1 represents perfect health, while 0 represents death. Negative scores are possible for health states considered "worse than dead". The second is an EQ-VAS score, a direct self-assessment on a visual analog scale from 0 (worst imaginable health) to 100 (best imaginable health). |
Countries
United States
Contacts
CONTACTLuke A Johnson, BS
CONTACTJamie Egbert, MS
Outcome results
None listed