Platelet Rich Plasma Injections In Young And Old Human Subjects

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of injections made from a patient's own blood, known as Platelet Rich Plasma (PRP), on knee osteoarthritis. The researchers want to learn how these injections might change certain proteins in the blood and improve knee pain in people with osteoarthritis. The study will include about 60 participants divided into two age groups (18-45 years and 46-70 years) who will receive either a PRP injection or a normal saline (saltwater) injection as a control. After 12 weeks, those who initially received the saline can switch to PRP.

To be eligible for the study, participants should have been experiencing knee pain due to osteoarthritis for at least three months and have a specific grade of knee osteoarthritis. They must not have received any knee injections or surgeries related to osteoarthritis in the past six months and should be able to attend physical therapy. Participants will be followed for up to 26 weeks, with several check-ins to assess their progress. This trial is not yet recruiting, but it aims to find out if PRP can help reduce knee pain and improve function for those suffering from osteoarthritis.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Grade 1-3 KL score will be recruited;
• • 2. Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee;
• • 3. Have symptomatic complaints from osteoarthritis pain in no other joint affecting the hips, ankles or unaffected knee;
• • 4. Will be able to attend and perform physical therapy.
• • 5. English-speaking
• • Exclusion Criteria
• 1. Patients will be excluded if:
• • 1. Received injection therapy for knee osteoarthritis in the past 6 months
• • 2. Have signs of concomitant osteoarthritis of 1 or more other major joints of the lower extremities that impair their daily activity level
• • 3. History of septic arthritis
• • 4. Have underwent a previous knee surgery specifically for osteoarthritis or osteochondral defects less than 1 year before randomization (i.e. autograft or allograft surgery
• • 5. High tibial osteotomy, partial knee replacement, patellar resurfacing), total knee replacement or existing surgical hardware in the knee
• • 6. Patient with platelet disorders, bleeding disorder
• • 7. Patient with rheumatologic disease, automimmune disorder, immunocompromised status, active history of cancer
• • 8. Patient taking Chemotherapy, need for regular prednisone or antiinflammatory used
• • 9. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• 10. Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:
• • i. Acute myocardial Infarction (within 5 days of any planned study procedure); ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute (within 3 months) pulmonary embolus or pulmonary infarction; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Room air desaturation at rest ≤85%; xv. Respiratory failure; xvi. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis); and xvii. Mental impairment leading to inability to cooperate.