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Market & Competition

QuantiPedics, in partnership with Ossur, is defining a new space for biomechanical testing fixtures .

skeleton leg

V3: The First Player in the Market

Our device is novel and so is the market we are creating. The current industry method of validating effectiveness of commercial knee braces lies in live patient clinical trials or cadever biomechanical testing. While V3 is not an anatomic replica of the knee, it effectively functions to measure the moment forces active in the the knee brace and knee joint complex in a quantitative, reliable, and reproducible manner. As of yet, there exists no commercial mechanical testing device focused on verifying the unloading efficacy of knee braces on the market.

Sources:

  1. Effect of Unloading brace treatment on pain and function in patients with symptomatic knee OA: the ROTOR randomized clinical trial
  2. Method for evaluating effect of unloader knee braces on joint health: a review
  3. The clinical effect of an unloader braceon patients with osteoarthritis of the knee, a randomized placebo controlled trial with one year follow up
  4. An Update on Unloadin Knee Braces in the Treatment of Unicompartmental Knee Osteoarthritis from the Last 10 Years: A Literature Review
  5. Benchtop Mechanical Performance of Prophylactic Knee Braces under Dynamic Valgus Loading: A Cadaver Study
  6. Comparison of rehabilitative knee braces: A biomechanical investigation

Current Competition/Test Methods

Live Patient Knee Brace Validation

Clinical trials are the main method of evaluating knee brace efficacy. Such tests predominantly relay semiquantitative, self-reported evidence through the employment of questionaires and visual scales such as:

  • Visual Analogue Scale (VAS)
  • Quality of Life Scale (QOLS)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS)
  • Knee Society Score (KSS)
  • Western Ontario and McMaster Universities' Arthiritis Index (WOMAC)
  • International Physical Activity Questionaire
These questionaries ask patients to evaluate their perception of pain, symptoms, daily activity level, recreational activity level, and quality of life. Overall, this method is predominantely subjective qualitative verification to gauge the user experience with the unloader knee brace. Limitations of clinical trials to verify knee brace efficacy include ethical and safety limitations in regards using live patients, lack of patient compliance, as well as wide methodological variation in clinical test set up and execution.

Cadaver Knee Brace Validation

Cadavers are also used for biomechanical knee brace testing. Yet less literature is available on the use of cadavers with unloader braces. They are mainly used to test stability braces that restrain an indivduals movement post-knee surgery. It is reported that this method of testing is less sought after due to:

  • Difficulty in obtaining specimen that fit the age group of the average knee OA patient
  • Inadaquate cadaver tissue compliance compared to living tissue that leads to non-uniform biomechanical output data