What is the study measuring?
1
Primary Endpoint
Our primary study endpoints are success rates of DRG-S treatment at 3 months post implant follow ups. Treatment success will be defined as >50% reduction in VAS pain score from baseline with no significant stimulation-related complications.
2
Questionaires to measure improvements
Our secondary endpoints include success rates of DRG-S at 1-, 6-, 9-, and 12-months. Western Ontario and McMaster Universities Arthritis Index (WOMAC) for knee pain patients, EQ-5D, SF-36 MCS component, Pain Disability Index (PDI), Patient Global Impression of Change (PGIC), and medication usage, divided into narcotic analgesics measured in morphine milligram equivalents (MME) and non-narcotic analgesics, will also be measured at all time points.
3
Utilizing Technology to assess improvements
Video recordings of motor task will be used to measure timed up and go (TUG) scores, index knee range of motion, and for qualitative descriptive analysis. Health measurements provided by the Apple Watch wearable monitoring device will also be recorded continuously for duration of the study. A supplement for this study protocol is provided detailing the clinical investigation data collection design and motor task video recording.
4
Biomarkers
Additional secondary endpoints will be serum concentrations of molecular biomarkers related to knee OA including but not limited to C-telopeptide of crosslinked collagen type I and type II (CTX-I and CTX-II).
Outcomes measured:
(for medical providers)
Let's Work Together
If you have medical questions, please reach out to our team of medical practitioners at research@spinepainny.com