Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis

NCT05742763 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: PRP-NSAIDs-KOA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Osteoarthritis of the Knee; Degenerative Osteoarthritis; Knee Pain Chronic

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

Outcome Measures

Primary Outcomes (4)

• 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".

  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".

  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".

  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".

  Scores obtained and assessed for a change at each office visit - at baseline (time 0), month 1, 2, 3, 4, 6, 9 and 12.

Study Arms (3)

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.

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.

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.

Combination Product: Placebo and PRP

Interventions

Ibuprofen and PRP COMBINATION_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.

Ibuprofen and PRP

Acetaminophen and PRP COMBINATION_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 PRP

Placebo and PRP COMBINATION_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 PRP

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• QC Kinetix LLC: lead

Study Sites (1)

QC Kinetix Franchise Group, LLC, 309 South Sharon Amity Rd, Ste 302

Charlotte, North Carolina, 28211, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases; Osteoarthritis; Knee Injuries

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Kenneth P Barnes, MD, MSc.

  QC Kinetix LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 24, 2023
• Study Start: November 1, 2023
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)