VIGOR: Virtual Genome Center for Infant Health

STUDY OVERVIEW

This study led by Boston Children’s Hospital aims to evaluate the implementation of a virtual genome center (VIGOR) in community clinical settings, providing insights into scaling up genomic medicine and improving access to cutting-edge care for low-income and minority populations, particularly sick newborns in NICUs. VIGOR will offer education, expert consultation, and access to innovative therapies, bridging the gap between specialized centers and community settings. By addressing disparities in genomic medicine and enhancing provider capacity, this intervention has the potential to revolutionize healthcare delivery for underserved populations.

STUDY GOALS

The study aims to ensure equitable access to advanced genomic medical care for sick newborns in community centers serving predominantly low-income and minority populations. By establishing a virtual genome center (VIGOR), the research seeks to offer education for physicians and families, expert genomic consultation, reanalysis of unsolved sequencing data, and access to cutting-edge therapies. This initiative intends to embed genomic best practices within community settings, extending beyond specialized referral centers to promote comprehensive healthcare delivery.

LOCATION

El Paso, Texas: The Hospitals of Providence

INCLUSION CRITERIA

  • Participants must be 18 years or older at the time of screening.

  • Participants must exhibit clinical and radiographic signs of knee osteoarthritis (OA), including tenderness, swelling, stiffness, and limited range of motion, diagnosed as Grade 2 to 3 by weight-bearing X-ray within the past 3 months.

  • The index knee must have symptomatic pain, as indicated by a WOMAC-A Visual Analog Scale (VAS) score of 40mm or higher, despite undergoing conservative treatments for at least 3 months.

  • Participants must be willing to provide written informed consent and comply with study procedures.

  • Participants must be able to attend multiple follow-up visits and communicate in English.

  • Females of childbearing potential must have a negative pregnancy test within 7 days of enrollment or meet postmenopausal/surgically sterilized criteria.

exclusion criteria

  • Participants with knee OA classified as K/L grade 1 or 4.

  • BMI greater than 35 kg/m².

  • Diagnosis of certain arthritis types or disorders contributing to knee pain.

  • Active infection in the knee joint or elsewhere, or recent knee injections or surgeries.

  • Bilateral knee pathology or significant knee deformities.

  • Current or historical autoimmune diseases requiring immunosuppressive therapy.

  • Planned surgery within the next 12 months or history of certain medical conditions.

  • Allergies to specific medications or diagnosis of certain diseases.

  • Recent chemotherapy, radiation therapy, or coagulation disorders.

  • Recent knee trauma, untreated symptomatic injuries, or certain medical issues contraindicating study treatment.

  • Women who are pregnant, breastfeeding, or unwilling to use contraception post-procedure.

  • Certain medication usage or incarceration status.

  • Uncontrolled diabetes, hypertension, asthma, cardiovascular, or other medical conditions.

  • Significant abnormalities in vital signs or history of septic arthritis or infection.

  • Recent changes in prescription medications.

For more information, visit ClinicalTrials.gov.