Osteoarthritis of the KneePhase 1/2PRPNSAIDsKOANCT05742763
Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis
A Phase 1/2 study testing Ibuprofen and PRP and Acetaminophen and PRP in people with Osteoarthritis of the Knee and Degenerative Osteoarthritis, run by QC Kinetix LLC at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee, Degenerative Osteoarthritis, Knee Pain Chronic
- What is being tested?
- Ibuprofen and PRP and Acetaminophen and PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 7 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >50 (all genders, and all races)
- Unilateral Symptoms
- Symptomatic knee pain on most days in the past month
- OA diagnosed with radiographic imaging (K-L grade 2 or 3)
- Can commit to 8 office visits (initial and 7 follow up) over a 12-month period
- 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.
Who cannot join
- K-L grade 1 (indicting questionable disease) or grade 4 (indicating severe disease)
- 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
- Had injection into the target knee joint of glucocorticoid in the past 3 months or hyaluronic acid in the past 6 months
- Had any autologous blood product or stem cell preparation in the past
- Had knee surgery on their target knee within the past 12 months
- Have systemic or inflammatory joint disease such as rheumatoid arthritis
Show all 28Show fewer
- Have a history of crystalline or neuropathic arthropathy
- Had a knee joint replacement or high tibial osteotomy on their target knee
- Plan to have knee surgery in the target knee in next 12 months
- Have other muscular, joint, or neurological condition affecting lower limb function
- Osteonecrosis, avascular necrosis
- Gastrointestinal reflux disease or peptic ulcer disease
- NSAID intolerance
- Renal dysfunction or liver disease
- Previous gastric bypass surgery
- Have a needle phobia
- Have immunosuppression or acute infective processes
- Have cancer or other tumors in the last 3 years, or undergone any treatment for cancer or tumors in the last 3 years
- Have a bleeding disorder or are receiving anticoagulation therapy
- Have the presence of a warm, tense joint effusion
- Have a platelet count < 150,000/μL
- Have any other medical condition precluding participation in the study
- Pregnancy
- 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
- Have a body mass index (BMI) > 40 kg/m2
- Have a weight ≤ 100 pounds
- Unable to attend all study appointments (initial visit and 7 follow up visits) over 12 months
- Cannot understand written/spoken English
Trial locations and contacts
1 site in 1 country.
United States1 site
QC Kinetix Franchise Group, LLC, 309 South Sharon Amity Rd, Ste 302
Charlotte, North Carolina, 28211
About this study
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.
Read the detailed description
For this 5-year Research Project, the investigators propose to implement a prospective, double-blind, three-arm randomized placebo controlled clinical trial study design across multiple clinic sites in North Carolina and South Carolina. 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 leukocyte poor platelet-rich plasma (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 knee osteoarthritis (KOA), and grade 2 or 3 radiographic changes defined by the Kellgren-Lawrence (K-L) classification system. Data collected as part of the PRP-NSAIDs-KOA Trial will be used to: 1) inform the treatment of patients with moderate KOA using the orthobiologic PRP; 2) assess the use of ibuprofen vs acetaminophen vs placebo by serially evaluating pain score outcomes and functionality using standardized and validated pain subscales (Visual Analogue Scale (VAS), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcomes Score (KOOS), and the International Knee Documentation Committee (IKDC) in patients with moderate KOA randomized to three arms; and 3) assess and compare serial changes in composition of whole blood and PRP with the use of ibuprofen vs acetaminophen vs placebo. The investigators will also assess the clinical trial protocol process measures of feasibility, acceptability, and implementation to evaluate and improve multi-site clinical trial delivery at QC Kinetix clinic sites.
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).
- 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).
- 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.
- Being tested
- Ibuprofen and PRP, Acetaminophen and PRP, Placebo and PRP
- Keywords
- osteoarthritis, platelet-rich plasma, NSAIDs, knee, PRP, knee OA, pain scores, WOMAC, KOOS, VAS, IKDC, Western Ontario McMaster Universities Osteoarthritis Index, Knee injury and Osteoarthritis Outcomes Score, Visual Analogue Scale, International Knee Documentation Committee, Nonsteroidal Anti-Inflammatory Drug
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases, Osteoarthritis, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen and PRPCombination product
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 PRPCombination product
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 PRPCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen and PRP | Active comparator | 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. Receives: Combination Product: Ibuprofen and PRP |
| Acetaminophen and PRP | Active comparator | 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. Receives: Combination Product: Acetaminophen and PRP |
| Placebo and PRP | Placebo comparator | 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. Receives: Combination Product: Placebo and PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.
The investigators will obtain standardized and validated pain scores. The first is the VAS. The scale is 0-10. 0 is "no pain" and 10 is "unbearable pain".
Measured: 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.
The investigators will obtain standardized and validated pain scores. The second is the WOMAC. The scale is 0-96. 0 is "no pain and no loss of function" and 96 is "unbearable pain and complete loss of function".
Measured: 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.
The investigators will obtain standardized and validated pain scores. The third is the KOOS. The scale is 0-100. 0 is "no pain and no loss of function" and 100 is "unbearable pain and complete loss of function".
Measured: 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.
The investigators will obtain standardized and validated pain scores. The fourth is the IKDC. The scale is 0-100. 100 is "no pain and no loss of function" and 0 is "unbearable pain and complete loss of function".
Measured: Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Nov 2023
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Why it stopped: The study format without a crossover option for study participants enrolled in the control arm wasn't attractive to patients and we were unable to enroll any patients since enrollment began earlier this year, so the study will be withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- QC Kinetix LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth P Barnes, MD, MSc., Principal investigator, QC Kinetix LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742763
- Sponsor's protocol ID
- PRP-NSAIDs-KOA
- Acronym
- PRPNSAIDsKOA
- Status last verified
- Oct 2024
- First submitted
- 6 Feb 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05742763
- Acronym / sponsor ID
- PRPNSAIDsKOA / PRP-NSAIDs-KOA
- Keywords
- osteoarthritis, platelet-rich plasma, NSAIDs, knee, PRP, knee OA, pain scores, WOMAC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study format without a crossover option for study participants enrolled in the control arm wasn't attractive to patients and we were unable to enroll any patients since enrollment began earlier this year, so the study will be withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- QC Kinetix LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For this 5-year Research Project, the investigators propose to implement a prospective, double-blind, three-arm randomized placebo controlled clinical trial study design across multiple clinic sites in North Carolina and South Carolina. 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 leukocyte poor platelet-rich plasma (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 knee osteoarthritis (KOA), and grade 2 or 3 radiographic changes defined by the Kellgren-Lawrence (K-L) classification system. Data collected as part of the PRP-NSAIDs-KOA Trial will be used to: 1) inform the treatment of patients with moderate KOA using the orthobiologic PRP; 2) assess the use of ibuprofen vs acetaminophen vs placebo by serially evaluating pain score outcomes and functionality using standardized and validated pain subscales (Visual Analogue Scale (VAS), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcomes Score (KOOS), and the International Knee Documentation Committee (IKDC) in patients with moderate KOA randomized to three arms; and 3) assess and compare serial changes in composition of whole blood and PRP with the use of ibuprofen vs acetaminophen vs placebo. The investigators will also assess the clinical trial protocol process measures of feasibility, acceptability, and implementation to evaluate and improve multi-site clinical trial delivery at QC Kinetix clinic sites.
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).
- 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).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen and PRP | Active comparator | Combination Product: Ibuprofen and PRPWeight 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. |
| Acetaminophen and PRP | Active comparator | Combination Product: Acetaminophen and PRPWeight 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. |
| Placebo and PRP | Placebo comparator | Combination Product: Placebo and PRPPlacebo 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >50 (all genders, and all races)
- Unilateral Symptoms
- Symptomatic knee pain on most days in the past month
- OA diagnosed with radiographic imaging (K-L grade 2 or 3)
- Can commit to 8 office visits (initial and 7 follow up) over a 12-month period
Key exclusion criteria (28 listed)
- K-L grade 1 (indicting questionable disease) or grade 4 (indicating severe disease)
- 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
- Had injection into the target knee joint of glucocorticoid in the past 3 months or hyaluronic acid in the past 6 months
- Had any autologous blood product or stem cell preparation in the past
- Had knee surgery on their target knee within the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen and PRPThe 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. | Combination product | Ibuprofen and PRP |
| Acetaminophen and PRPThe 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. | Combination product | Acetaminophen and PRP |
| Placebo and PRPThe 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. | Combination product | Placebo and PRP |
Primary outcome
VAS pain scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.
Time frame: Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.
The investigators will obtain standardized and validated pain scores. The first is the VAS. The scale is 0-10. 0 is "no pain" and 10 is "unbearable pain".
WOMAC pain and functionality scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.
Time frame: Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.
The investigators will obtain standardized and validated pain scores. The second is the WOMAC. The scale is 0-96. 0 is "no pain and no loss of function" and 96 is "unbearable pain and complete loss of function".
KOOS pain and functionality scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.
Time frame: Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.
The investigators will obtain standardized and validated pain scores. The third is the KOOS. The scale is 0-100. 0 is "no pain and no loss of function" and 100 is "unbearable pain and complete loss of function".
IKDC pain and functionality scores after combination interventions of blinded medication therapy and a series of 3 PRP injections.
Time frame: Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.
The investigators will obtain standardized and validated pain scores. The fourth is the IKDC. The scale is 0-100. 100 is "no pain and no loss of function" and 0 is "unbearable pain and complete loss of function".
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth P Barnes, MD, MSc. principal investigator
QC Kinetix LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ibuprofen and PRP and Acetaminophen and PRP in people with Osteoarthritis of the Knee and Degenerative Osteoarthritis, run by QC Kinetix LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain scores after combination interventions of blinded medication therapy and a series of 3 PRP injections. (time frame: Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.