Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Synovial Fluid Molecular/Stem Cell Response to PRP in Knee Osteoarthritis: Clinical & Imaging Outcome Correlation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468492
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : August 16, 2017
Sponsor:
Collaborator:
Foundation for Physical Medicine and Rehabilitation
Information provided by (Responsible Party):
Dr. Lance Goetz, Hunter Holmes Mcguire Veteran Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE May 31, 2015
First Posted Date  ICMJE June 10, 2015
Last Update Posted Date August 16, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
Biochemical Molecular Outcomes [ Time Frame: Baseline and 10 day follow up ]
Evaluate for change in biochemical molecular milieu temporal response after PRP injection or normal saline (control) compared to baseline, as measured by multiplex suspension array technology.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02468492 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
  • Clinical Outcomes [ Time Frame: 1 year ]
    Evaluation for change in pain level via VAS and WOMAC at baseline and follow up.
  • Imaging Outcomes [ Time Frame: 6 months ]
    Evaluation for change in joint space width using knee radiographs at baseline and 6 month follow up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Synovial Fluid Molecular/Stem Cell Response to PRP in Knee Osteoarthritis: Clinical & Imaging Outcome Correlation
Official Title  ICMJE Synovial Fluid Biomarker and Mesenchymal Stem Cell Response to PRP in Knee Osteoarthritis With Clinical and Imaging Outcome Correlation: Proof of Concept Study
Brief Summary The purpose of this study is to evaluate the affect that platelet rich plasma has on the molecular an cellular functioning of the knee joint.
Detailed Description In this study 18 subjects with mild to moderate symptomatic knee osteoarthritis will be recruited per an IRB approved protocol with explicit inclusion and exclusion criteria. Subjects who are enrolled and meet all criteria will be blinded and randomized (2:1) to receive Platelet Rich Plasma or normal saline "control". Prior to the intervention, a synovial fluid aspiration will occur. At follow up number one (approximately 10 days from baseline) a repeat aspiration will occur and a differential analysis of the molecular and biochemical effects will be undertaken; this data will serve as the primary outcome measures. This data will be correlated to clinical and imaging outcome measures which will be secondary outcome measures completed at baseline and intermittently throughout the study. The duration of the study is one year.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Biological: Platelet Rich Plasma
    Platelet rich plasma injection into knee versus placebo (saline) injection.
    Other Name: Platelet Concentrate
  • Other: Normal Saline
    Platelet rich plasma injection into knee versus placebo (saline) injection.
Study Arms  ICMJE
  • Experimental: Platelet Rich Plasma
    Approximately 5mL of intraarticular PRP once at baseline
    Intervention: Biological: Platelet Rich Plasma
  • Normal Saline
    Approximately 5mL of intraarticular normal saline once at baseline
    Intervention: Other: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2015)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Early/Mild to Moderate Stage knee osteoarthritis (KOA), as determined by Kellgren-Lawrence Grade 2 to 3 on PA standing radiograph within the past three months;

    • A prospective subject who has a diagnosis of non-end stage KOA (i.e., a potential study candidate) and expresses interest in participating but has no XRAY within the specified time-period will be sent for a fresh XRAY. This XRAY will be read by a radiologist & be paid for by the study.
  2. >=40 years of age;
  3. Average 100-point VAS score of >50, on average, within the past 3 months*, with KOA felt to be the primary contributor to pain.

    • Alternate 10-point scales with pain scores averaging >5 may be considered if the prospective subject also completes a VAS with score >50 at screening.
  4. Exam consistent with KOA being primary etiology of pain;
  5. No signs of inflammatory arthropathy in medical record, history or physical examination;
  6. A >3 millimeter intra-articular (IA) effusion present on ultrasound evaluation.
  7. [If a chronic liver or renal disease patient, evidence of stable disease over/within the past six months, else exclusion.]
  8. Veteran receiving care at McGuire VAMC.

Exclusion Criteria:

  1. Morbid obesity (BMI >40);
  2. Poorly controlled diabetes (hemoglobin A1C > 7.5 or fasting blood glucose of >200) in last 6 months;
  3. Ipsilateral knee surgery, trauma within last 6 months, or corticosteroid injection within 3 months.
  4. 4. History of inflammatory arthropathy (RA, SLE or crystalline arthritis of the knee)**;
  5. Any rheumatoid arthritis or gout diagnosis is exclusionary.
  6. Current infection of the affected joint or any other uncontrolled or untreated active infection.
  7. Moderate to severe anemia (hemoglobin < 11 g/dl) or thrombocytopenia (platelet count < 100,000); Hemoglobin >17 g/dl or <11 g/dl and/or platelet counts >500,000 or <100,000 platelets/μl.

    • [CBC obtained within 6 months will be required, even if obtained at initial screening visit.]
  8. Individuals on dialysis, with liver failure, or uncontrolled renal or liver disease are excluded.

    • In those with chronic renal or liver disease, documentation of stable disease within the most recent 6 months will be required.
  9. Individuals on a therapeutic anticoagulant (e.g., Warfarin, Dabigatran, Enoxaparin) and those with a history of coagulopathy are excluded.

    • Per standard clinical practice, subjects on anti-platelet therapy are not excluded.
  10. Pregnancy or breast-feeding;

    • Female subjects of child-bearing potential must have a negative pregnancy screen prior to enrollment.
    • Female subjects of child-bearing potential must confirm they are not actively breast-feeding prior to enrollment.
  11. Current illicit drug abuse / active alcohol abuse (i.e, Current substance abuse);
  12. Uncontrolled psychiatric disorder;
  13. Lack of transportation (i.e., to get to/from appointments at VAMC) and/or willingness to attend study appointments (screening/consent, Intervention, Day10-follow-up, Month-6 follow-up, and then visits over-the-phone / in-person / or via Telehealth for Month-3 and Month-12;
  14. Advanced or currently active cancer.
  15. Blood disorders (such as Sickle Cell Anemia, TTP, others)
  16. Vulnerable populations: Individuals incapable of making informed decisions will not be enrolled, nor will those under some form of incarceration.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02468492
Other Study ID Numbers  ICMJE IRB #01979/FDA IDE#15944
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Publications planned.
Responsible Party Dr. Lance Goetz, Hunter Holmes Mcguire Veteran Affairs Medical Center
Study Sponsor  ICMJE Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators  ICMJE Foundation for Physical Medicine and Rehabilitation
Investigators  ICMJE
Principal Investigator: Lance L Goetz, MD Hunter Holmes McGuire VAMC
PRS Account Hunter Holmes Mcguire Veteran Affairs Medical Center
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP