Clinical Trials

Overview Of Clinical Trials

Currently we are in the second year of a prospective randomized clinical trial
against current standard of care (SoC) for total knee arthroplasty (TKA) patients. The trial enrolled the first patient in 2016 and now have enrolled and treated over 100 patients with the device.

Inclusions & Duration

Inclusions:
Knee flexion contracture with deficit limiting active range of motions (RoM and passive RoM by at least 10° pre-op ≥ 18 YO.

Duration:

7 to 10 weeks (pre-op and post-op follow up)

Note: Trial results of this report are interim reports and not based on the completed trial. The trial is expected to be completed, data compiled and reported within approximately 2 months.

Key Outcomes From Clinical Trial

  • April 2016: Improved range of motion (RoM) 35% vs. 18% for Standard of Card (SoC)/Control Group
  • April 2016: Improved KOOS score 13% vs. decreased KOOS score 17% for SoC/Control
  • June 2016: Decreased pain 26% vs. 56% increased pain for SoC/Control
  • October 2016: 131° RoM reclaimed vs. 64° RoM reclaimed for SoC/Control
  • July 2017: Only the KneeMD experiment group saw an improvement in KOOS in experimental time period
  • September 2018: Near-final results. KneeMD improved RoM, KSS and KOOS scores across all time points