Clinical trial
Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis
Name
PRP-NSAIDs-KOA
Description
The primary research purpose is to determine if the use of a drug therapy intervention (each study participant will be randomly assigned to receive one of 3 study medications which will be blinded from everyone, including the study participants, and all research staff (except the principal investigator), combined with a series of 3 injections of Platelet-Rich Plasma (PRP) into an osteoarthritic knee joint, leads to reductions in knee pain, and improvements in physical function. Improvements will be assessed by serially evaluating pain scores and functionality using standardized and validated questionaires which will be completed by the study participant at each clinic office visit. In addition, blood tests will be drawn at each visit to evalute any changes in blood compostion. If the participant meets the study inclusion and exclusion criteria and agrees to attend 7 follow up office visits, they will be eligble to enroll in the study. If they wish to volunarily enroll in the study, it will be explained in detail, afterwhich all questions and any concerns will be answered. Each office visit will take between 30-45 minutes and will take place over a 12-month study period comittment.
Trial arms
Trial start
2023-11-01
Estimated PCD
2026-12-31
Trial end
2026-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Ibuprofen and PRP
The primary research purpose is to determine if the use of ibuprofen \[arm #1\] vs acetaminophen \[arm #2\] vs a placebo control group \[arm #3\] with the intervention of a series of three injections of LP-PRP into the knee joint, leads to significantly greater reductions in average knee pain severity, and increases in physical function and quality of life, in patients with symptomatic moderate KOA, and grade 2 or 3 radiographic changes defined by the Kellgren-Lawrence (K-L) classification system.
Arms:
Ibuprofen and PRP
Acetaminophen and PRP
The primary research purpose is to determine if the use of ibuprofen \[arm #1\] vs acetaminophen \[arm #2\] vs a placebo control group \[arm #3\] with the intervention of a series of three injections of LP-PRP into the knee joint, leads to significantly greater reductions in average knee pain severity, and increases in physical function and quality of life, in patients with symptomatic moderate KOA, and grade 2 or 3 radiographic changes defined by the Kellgren-Lawrence (K-L) classification system.
Arms:
Acetaminophen and PRP
Placebo and PRP
The primary research purpose is to determine if the use of ibuprofen \[arm #1\] vs acetaminophen \[arm #2\] vs a placebo control group \[arm #3\] with the intervention of a series of three injections of LP-PRP into the knee joint, leads to significantly greater reductions in average knee pain severity, and increases in physical function and quality of life, in patients with symptomatic moderate KOA, and grade 2 or 3 radiographic changes defined by the Kellgren-Lawrence (K-L) classification system.
Arms:
Placebo and PRP
Size
300
Primary endpoint
VAS pain scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.
Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.
WOMAC pain and functionality scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.
Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.
KOOS pain and functionality scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.
Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.
IKDC pain and functionality scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.
Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.
Eligibility criteria
Inclusion Criteria:
1. Age \>50 (all genders, and all races)
2. Unilateral Symptoms
3. Symptomatic knee pain on most days in the past month
4. OA diagnosed with radiographic imaging (K-L grade 2 or 3)
5. Can commit to 8 office visits (initial and 7 follow up) over a 12-month period
6. Able to understand written/spoken English - all study participants will be provided with an overview of the study goals, research activities and tasks, and an opportunity to address any questions, comments, or concerns about their participation in the PRP_NSAIDs-PRP research trial. After which, written informed consent and HIPPA Research Disclosure form will be obtained.
Exclusion Criteria:
1. K-L grade 1 (indicting questionable disease) or grade 4 (indicating severe disease)
2. Have lateral joint space narrowing greater than or equal to medial joint space narrowing on x-ray using the Osteoarthritis Research Society International (OARSI) atlas
3. Had injection into the target knee joint of glucocorticoid in the past 3 months or hyaluronic acid in the past 6 months
4. Had any autologous blood product or stem cell preparation in the past
5. Had knee surgery on their target knee within the past 12 months
6. Have systemic or inflammatory joint disease such as rheumatoid arthritis
7. Have a history of crystalline or neuropathic arthropathy
8. Had a knee joint replacement or high tibial osteotomy on their target knee
9. Plan to have knee surgery in the target knee in next 12 months
10. Have other muscular, joint, or neurological condition affecting lower limb function
11. Osteonecrosis, avascular necrosis
12. Gastrointestinal reflux disease or peptic ulcer disease
13. NSAID intolerance
14. Renal dysfunction or liver disease
15. Previous gastric bypass surgery
16. Have a needle phobia
17. Have immunosuppression or acute infective processes
18. Have cancer or other tumors in the last 3 years, or undergone any treatment for cancer or tumors in the last 3 years
19. Have a bleeding disorder or are receiving anticoagulation therapy
20. Have the presence of a warm, tense joint effusion
21. Have a platelet count \< 150,000/μL
22. Have any other medical condition precluding participation in the study
23. Pregnancy
24. Are unwilling to discontinue any use of an NSAID, acetaminophen, and other analgesic usage, from 1 month before the baseline assessment until the last follow-up assessment at month 12
25. Have a body mass index (BMI) \> 40 kg/m2
26. Have a weight ≤ 100 pounds
27. Unable to attend all study appointments (initial visit and 7 follow up visits) over 12 months
28. Cannot understand written/spoken English
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2024-04-03
1 organization
3 products
3 indications
Organization
QC KinetixProduct
IbuprofenIndication
Osteoarthritis of the KneeIndication
OsteoarthritisIndication
Chronic Knee PainProduct
AcetaminophenProduct
Placebo