The double-blind, randomized, sham-controlled study, enrolling 150 patients, is designed to assess the effectiveness of PRF treatment with the Amp technology for amelioration of knee pain.
The study is also designed to assess the duration of clinical benefit following discontinuation of treatment.
The primary endpoint of the trial is a comparison of changes in current knee pain severity at 4 weeks over baseline.
Secondary endpoints include measures of knee pain severity, quality of life based on patient assessment instruments and reduction in use of concomitant pain medications and modalities.
Amp CEO Eric Dremel said they are hopeful that this trial will show that PRF treatment can offer an effective pain reduction alternative to more invasive procedures.
"We are confident that the Amp technology has broad therapeutic and commercial potential in a wide range of orthopedic indications, and look forward to broaden our pipeline with additional PRF based products in the near future," Dremel said.
