Retrospective pilot survey of a novel TRI-COMPARTMENT OFFLOADER
Preliminary evaluation of a new orthotic for multi-compartment knee osteoarthritis: a retrospective pilot survey
Budarick, A.R., Bishop, E.L., and Cowper-Smith, C.D. (2020). Journal of Prosthetics and Orthotics. Under Peer Review.
100% of participants with knee OA experienced a reduction in pain with the Levitation knee brace.
97.5% of participants scored higher LEFS scores that surpassed the minimum clinically relevant difference.
Increased physical activity
70% of participants with knee OA indicated increased weekly physical activity levels.
This case series explored the clinical benefits of the Levitation tri-compartment offloader (TCO) among patients with diverse patterns of knee osteoarthritis (OA). Unlike previous bracing studies, this study did not limit its study population to individuals with similar OA patterns or symptoms.
A survey was completed in a group of 40 adults who exhibited varied patterns of activity-related knee pain characteristic of patellofemoral (PF), tibiofemoral (TF), or combined PF and TF OA. Participants used the TCO brace for at least 1 month and reported on outcomes including pain, function, physical activity, quality of life, and use of medications and other treatments before and after brace use.
Validated outcome measures including the visual analog scale (VAS) and the Lower Extremity Functional Scale (LEFS) were used to assess pain and physical function, respectively. Exploratory measures were used to quantify physical activity levels and use of medication and other treatments.
Following TCO brace use, patients reported significant improvements in measures related to pain, function, mobility, and use of medication and other treatments. These findings indicate strong promise for the TCO brace to serve as a conservative treatment gap for individuals with varied knee pain symptoms indicative of PF or multi-compartmental OA.
Major findings can be summarized as follows:
- All 40 participants experienced reduced knee pain. The average total VAS score after TCO brace use was significantly lower than baseline.
- 97.5% of participants had increased LEFS scores after TCO brace use. The LEFS score improvements surpassed the minimal clinically relevant difference (MCID) among all symptom groups.
- 70% of participants experienced increased physical activity with the use of the TCO. Weekly physical activity levels increased by 2.2 hours, 7.3 hours, and 9.4 hours for the TFOA, PFOA, and Combined groups, respectively.
- Weekly medication use significantly decreased among the 65% of participants who reported using medication at baseline.
- 60% of participants reported a decrease in their use of at least one other treatment for their knee OA, including allied health services, injections, and aids.
The improvement in pain scores with Levitation for all OA types exceeded the externally validated “PASS” threshold (orange line) 1 - Tubach et al. 2005. Ann Rheum Dis. 64(1); that is, the pain score below which patients typically consider themselves well.
A statistically significant improvement in functional scores was above the minimum clinically relevant threshold of 9 points on the LEFS scale for all OA symptom groups.
Participants ranked the effectiveness of Levitation versus other knee braces they had personally used. Participants consistently ranked Levitation as more effective.
University of Waterloo
Dr. Emily Bishop
University of Calgary
Dr. Chris Cowper-Smith
Spring Loaded Technology
University of Calgary
Spring Loaded is currently collaborating with researchers at the University of Calgary to understand how the use of the Levitation knee brace influences user-reported outcomes such as pain, knee function, quality of life, physical activity levels and use of medication and other treatments. U of C researchers are also quantifying the potential of Levitation to offload the patellofemoral and tibiofemoral knee compartments.