Knee Osteoarthritis Clinical Trial
Official title:
Synovial Fluid Biomarker and Mesenchymal Stem Cell Response to PRP in Knee Osteoarthritis With Clinical and Imaging Outcome Correlation: Proof of Concept Study
Verified date | August 2017 |
Source | Hunter Holmes Mcguire Veteran Affairs Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Hunter Holmes McGuire VA Medical Center | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Hunter Holmes Mcguire Veteran Affairs Medical Center | Foundation for Physical Medicine and Rehabilitation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biochemical Molecular Outcomes | 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. | Baseline and 10 day follow up | |
Secondary | Clinical Outcomes | Evaluation for change in pain level via VAS and WOMAC at baseline and follow up. | 1 year | |
Secondary | Imaging Outcomes | Evaluation for change in joint space width using knee radiographs at baseline and 6 month follow up. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04651673 -
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
|
||
Completed |
NCT05677399 -
Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
|
N/A | |
Active, not recruiting |
NCT04043819 -
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
|
Phase 1 | |
Recruiting |
NCT06000410 -
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
|
Phase 3 | |
Completed |
NCT05014542 -
Needling Techniques for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05892133 -
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05528965 -
Parallel Versus Perpendicular Technique for Genicular Radiofrequency
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Active, not recruiting |
NCT02003976 -
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
|
N/A | |
Active, not recruiting |
NCT04017533 -
Stability of Uncemented Medially Stabilized TKA
|
N/A | |
Completed |
NCT04779164 -
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT04006314 -
Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05423587 -
Genicular Artery Embolisation for Knee Osteoarthritis II
|
N/A | |
Enrolling by invitation |
NCT04145401 -
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
|
||
Active, not recruiting |
NCT03781843 -
Effects of Genicular Nerve Block in Knee Osteoarthritis
|
N/A | |
Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05324163 -
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
|
Phase 3 | |
Completed |
NCT05529914 -
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05693493 -
Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?
|
N/A | |
Not yet recruiting |
NCT05510648 -
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
|
N/A |