This is a prospective, multi-center, randomized, study in which 300 evaluable subjects will
      be randomized 1:1 to receive active or delayed therapy with Moments PNS. Subjects in the
      Delayed group will start with therapy at 3-month visit follow up. The primary endpoint is a
      >50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in
      baseline pain medications, with additional measurements assessed at 3, 6, 9, 12, 24, and
      36-months.

Clinical Trial of the MiniStim PNS for Knee Pain- "FLEX" Study

Chronic Knee Pain

This is a prospective, randomized, controlled, multi-center study in which up to 300
      evaluable subjects will receive MiniStim PNS. Target subjects will have chronic knee pain.

      Subjects will be randomized into either the active or delayed group. Devices will be
      activated post-op in accordance to the randomization assignment. Subjects randomized to the
      Active group, programming parameters will be set, and therapy will be delivered for a minimum
      of 2-hours per day for the duration of the study. Implanted subjects will be educated on the
      use of the transmitter. Programming changes can be done as needed during this time period to
      maximize clinical response according to pre-programmed settings. Subjects randomized to the
      Delayed group will begin 2-hour stimulation/day at the 3-Month visit.

      The primary endpoint will be at 3-Months, comparing Active vs. Delayed data from baseline
      data, and subjects in the Delay group will begin stimulation. At the 3-month visit, VAS will
      be completed and compared to baseline VAS, during this visit the safety and efficacy of the
      device will be assessed, and subjects in the Delayed group will be instructed to begin daily
      stimulation for a minimum of 2 hours a day. Subjects will be seen at 3-month intervals
      through the 12-Month visit for data collection and adverse event review. Subjects will
      continue therapy and followed for a total of 36-months with primary outcomes assessed at
      3-months. Their participation in the study will end at 36-months.

MiniStim PNS

Prospective, Multi-center, Randomized Trial of the MiniStim PNS for Knee Pain- "FLEX" Study

Improvement pain defined as a >50% pain relief as measured by VAS without increase in baseline medications. To demonstrate clinically significant improvements in the pain of subjects in the active group compared to the subjects in the delayed group.

Device- and procedure-related Adverse Events (AE) rate at 3-months.

The ability to do one-legged knee bends (percentage increase in knee bends).

Change in Mental Component Score measured by SF-36 questionnaire measured on a scale of 1-5; 1 (all of the time) to 5 (none of the time).

Medication usage before and after treatment in active and delayed group subjects.

Change in knee range of motion as measured with Knee Range of Motion questionnaire.

Change in Physical Component Score measured by SF-36 questionnaire measured on a scale of 1-5; 1 (all of the time) to 5 (none of the time).

Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study.

The delayed group will begin 2-hour stimulation/day at the 3-Month visit.

Clinical Trial of the MiniStim PNS for Knee Pain- "FLEX" Study

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status