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

NCT ID: NCT02468492

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-11-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Platelet Rich Plasma

Approximately 5mL of intraarticular PRP once at baseline

Group Type: EXPERIMENTAL

Platelet Rich Plasma

Intervention Type: BIOLOGICAL

Platelet rich plasma injection into knee versus placebo (saline) injection.

Normal Saline

Approximately 5mL of intraarticular normal saline once at baseline

Group Type: OTHER

Normal Saline

Intervention Type: OTHER

Platelet rich plasma injection into knee versus placebo (saline) injection.

Interventions

Platelet Rich Plasma

Platelet rich plasma injection into knee versus placebo (saline) injection.

Intervention Type: BIOLOGICAL

Normal Saline

Platelet rich plasma injection into knee versus placebo (saline) injection.

Intervention Type: OTHER

Other Intervention Names

Platelet Concentrate

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Physical Medicine and Rehabilitation

OTHER

Sponsor Role: collaborator

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Dr. Lance Goetz

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lance L Goetz, MD

Role: PRINCIPAL_INVESTIGATOR

Hunter Holmes McGuire VAMC

Locations

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

IRB #01979/FDA IDE#15944

Identifier Type: -

Identifier Source: org_study_id