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Precision Assessment of Platelet Rich Plasma for Joint Preservation

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ClinicalTrials.gov Identifier: NCT03460236
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Knee Osteoarthritis (OA) is a leading cause of premature disability in Veterans who develop knee OA at higher rates and younger ages than the population in general. For those with symptomatic early knee OA, who are years to decades away from meeting clinical indications for knee replacement surgery, knee injections have been a key treatment option. In recent years, platelet rich plasma (PRP) injections have gained increasing attention for improving pain and function in patients with knee OA. Basic science studies also suggest that PRP may also potentially stimulate repair responses to articular cartilage. However, the mechanisms of action of PRP in the treatment of knee OA are unknown. Because autologous blood is used, the PRP composition differs between patients. It is also unknown whether these differences in PRP composition affect clinical outcomes. This study will address these gaps and provide critical new and objective information on PRP treatment effects in Veterans and additional women with early knee OA important to improving clinical use of this new treatment.

Condition or disease
Osteoarthritis

Detailed Description:
Because very little is known about either the mechanisms of action or objective clinical outcomes of PRP treatment for knee OA, the investigators propose a prospective "pre-post" study that will permit us to identify areas where more rigorous clinical outcomes and mechanistic research may be warranted. The proposed work includes special elements of: (1) quantitative metrics to assess clinical outcomes, (2) correlation of candidate beneficial proteins with clinical outcomes, and (3) proteomic evaluation of the injected PRP. This work will use an innovative multi-disciplinary, personalized approach to evaluate the effects of PRP composition on both function, as assessed by patient-reported outcomes and gait analysis, and cartilage matrix structure as assessed by quantitative MRI

Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precision Assessment of Platelet Rich Plasma for Joint Preservation
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : March 29, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort
PRP
Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.



Primary Outcome Measures :
  1. Change from baseline WOMAC Pain Score [ Time Frame: 6 months ]
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score is determined through patient reported outcomes using a standardized questionnaire to evaluate the condition of osteoarthritis of the knee. The WOMAC Pain scale consists of 5 questions, with each response valued on an ordinal scale of 0-4, and with at total score of 20. Higher numbers indicate more symptoms and physical disabilities.

  2. Change from baseline Knee Flexion Moment [ Time Frame: 6 months ]
    Knee Flexion Moment is a physiological parameter calculated via gait analysis. The knee flexion moment is the moment needed to bend the knee while in the stance phase of walking. The knee flexion moment has been linked to pain and function in patients with osteoarthritis.

  3. Change from baseline Walking Speed [ Time Frame: 6 months ]
    Walking speed has been linked to pain and function in patients with osteoarthritis.

  4. Change from baseline T2 [ Time Frame: 6 months ]
    Quantitative MRI mapping

  5. Change from baseline WOMAC Function Score [ Time Frame: 6 months ]
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score is determined through patient reported outcomes using a standardized questionnaire to evaluate the condition of osteoarthritis of the knee. The WOMAC Function scale consists of 17 questions, with each response valued on an ordinal scale of 0-4, and with at total score of 68. Higher numbers indicate more symptoms and physical disabilities.


Secondary Outcome Measures :
  1. Change from baseline MOAKS [ Time Frame: 6 months ]
    The MRI Osteoarthritis Knee Score (MOAKS) score is a semi-quantitative whole joint morphologic assessment of knee joint tissues in 14 subregions. Assessments are based on presence of Bone Marrow Lesions within the subregional volume (scale of 0-3, where none=0 and >66%=3), articular cartilage loss (scale of 0-3, where none=0 and >75%=3), presence of osteophytes in 12 of the 14 regions (scale of 0-3, where none=0 and large=3), Hoffa's synovitis and synovitis-effusion (scale of 0-3, where normal=0 and capsular distention=3), meniscus extrusion grading (scale of 0-3, where <2mm=0and >5mm=3), meniscus morphologic features present (Y/N; signal, tear, maceration, cyst, hypertrophy): ligaments and tendons (scale of 0-1, where normal=0 and complete tear/abnormality=1), and periarticular features = present or not (Hunter et al, 2011 Osteoarthritis Cartilage, 19:990-1002).


Biospecimen Retention:   Samples Without DNA
One tube of blood identified with a unique number.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
Criteria

Inclusion Criteria:

  • symptomatic early knee OA
  • full weight-bearing status
  • have elected to receive PRP treatment

Exclusion Criteria:

  • inflammatory arthritis, gout or recurrent pseudogout
  • symptomatic OA of other lower extremity joints
  • BMI >35 kg/m2
  • use of walking, orthopedic, or prosthetic assistive device
  • severe systemic disease defined as American Society of Anesthesiologists (ASA) 3 or above56
  • inability to have MRI
  • pregnant or intending to become pregnant during the study
  • predominantly patellofemoral disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460236


Contacts
Contact: Jennifer Erhart-Hledik, PhD (650) 493-5000 ext 62388 jerhart@stanford.edu
Contact: Gordhan B Mahtani, MSc (650) 493-5000 ext 64431 gmahtani@stanford.edu

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Gordhan B Mahtani, MSc    650-493-5000 ext 64431    gmahtani@stanford.edu   
Contact: Jessica L Asay, MS    (650) 493-5000 ext 65971    asay@stanford.edu   
Principal Investigator: Constance R. Chu, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Constance R. Chu, MD VA Palo Alto Health Care System, Palo Alto, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03460236     History of Changes
Other Study ID Numbers: F2452-R
43655 ( Other Identifier: IRB protocol number )
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
PRP
osteoarthritis
MRI
gait
patient reported outcome

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases