Precision Assessment of Platelet Rich Plasma for Joint Preservation

Osteoarthritis Clinical Trial

Official title:

Precision Assessment of Platelet Rich Plasma for Joint Preservation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460236
• Other study ID #: F2452-R
• Secondary ID: 43655
• Status: Completed
• Start date: April 2, 2018
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 31, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• symptomatic early knee OA

• full weight-bearing status

• have elected to receive PRP treatment

• Male veterans

• Female veterans

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

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline WOMAC Pain Score	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.	6 months
Primary	Change from baseline Knee Flexion Moment	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.	6 months
Primary	Change from baseline Walking Speed	Walking speed has been linked to pain and function in patients with osteoarthritis.	6 months
Primary	Change from baseline T2	Quantitative MRI mapping	6 months
Primary	Change from baseline WOMAC Function Score	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.	6 months
Secondary	Change from baseline MOAKS	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).	6 months