Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis
NCT ID: NCT05742763
Last Updated: 2024-10-09
Study Results
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Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2023-11-01
2024-10-07
Brief Summary
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Detailed Description
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The central hypothesis of the study is that patients receiving ibuprofen will initially report higher VAS, WOMAC, KOOS, and IKDC pain scores at each 1-month post-treatment follow up, with a return to baseline and progressively lower pain scores at each subsequent follow up visit when compared to patients in the other two arms. The long-term goal of this research study is to build the QC Kinetix workforce clinical research capacity in the conduct of sports and regenerative medicine related multi-site clinical trials and apply for the American Medical Society for Sports Medicine (AMSSM) Foundation Research Grant, the American College of Sports Medicine (ACSM) Research Grant, the Arthritis Society Research Grant, and the AMSSM Collaborative Research Network (CRN) Grant that builds on lessons learned from this research effort. The investigators will successfully achieve the primary research goal of this research study through the following four specific aims
Aim #1: During ongoing recruitment and enrollment, the investigators will identify and recruit patients with moderate KOA seen across new and established patients attending QC Kinetix clinic sites (i.e., North and South Carolina).
o H1-1: Based on our clinic data, the investigators expect patients on daily NSAIDs to have increased symptoms of pain and reduced function during the washout period of 1 month (all study participants must discontinue all analgesic medications including acetaminophen and NSAIDs) prior to the series of PRP injections.
Aim #2. Design and implement a prospective, 5-year double-blinded, three-arm randomized clinical trial study design across multiple QC Kinetix clinic sites (i.e., North and South Carolina) to compare VAS, WOMAC, KOOS, and IKDC pain and function subscale scores at baseline and follow-up visits at months 1, 2, 3, (drug therapy, PRP, and completion of pain subscales); months 4, and 6 (drug therapy and pain subscales) and months 9 and 12 (pain subscales only) post-enrollment and treatment following the initiation of the 3 PRP injections in all three groups \[arm #1-3\] in patients with symptomatic moderate KOA (K-L grade 2 or 3).
o H2-1: Patients who receive ibuprofen will initially report higher VAS, WOMAC, KOOS, and IKDC pain scores at each 1-month post-treatment follow up, with a return to baseline and progressively lower pain scores at each subsequent follow up visit when compared to patients in the other two arms.
Aim #3: Assess and compare changes in platelet count in the whole blood and PRP of all study participants at each clinic visit.
Aim #4: Evaluate process measures (i.e., feasibility, acceptability, and implementation) for clinical trial protocol success between and within all QC Kinetix clinic sites.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ibuprofen and PRP
Weight based Ibuprofen provided in over-encapsulated blister pack (to ensure blinding), to be taken 3 times a day for the initial 6 months of the 12 month study period. PRP injections provided at month 1, 2, and 3.
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.
Acetaminophen and PRP
Weight based Acetaminophen provided in over-encapsulated blister pack (to ensure blinding), to be taken 3 times a day for the initial 6 months of the 12 month study period. PRP injections provided at month 1, 2, and 3.
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.
Placebo and PRP
Placebo provided in over-encapsulated blister pack (to ensure blinding), to be taken 3 times a day for the initial 6 months of the 12 month study period. PRP injections provided at month 1, 2, and 3.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
ALL
Yes
Sponsors
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QC Kinetix LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth P Barnes, MD, MSc.
Role: PRINCIPAL_INVESTIGATOR
QC Kinetix LLC
Locations
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QC Kinetix Franchise Group, LLC, 309 South Sharon Amity Rd, Ste 302
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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PRP-NSAIDs-KOA
Identifier Type: -
Identifier Source: org_study_id
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