Research Summary

Retrospective pilot survey of a novel tri-compartment offloader

Preliminary evaluation of a new orthotic for patellofemoral and multicompartment knee osteoarthritis

Budarick, A.R., Bishop, E.L., Clarke, M.L., and Cowper-Smith, C.D. (2021). Rehabilitation Research & Practice. doi:10.1155/2021/5923721

Key Findings

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REDUCED PAIN

100% of participants with knee OA experienced a reduction in pain with the Spring Loaded knee brace.

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IMPROVED FUNCTION

97.5% of participants scored higher LEFS scores that surpassed the minimum clinically relevant difference.

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INCREASED PHYSICAL ACTIVITY

70% of participants with knee OA indicated increased weekly physical activity levels.

This case series explored the clinical benefits of the Spring Loaded 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.

Figure 1

The improvement in pain scores with a Spring Loaded brace 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.

Clinical study on Levitation 2 Knee brace at mccaig institute

Figure 2

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.

Figure 3

Participants ranked the effectiveness of a Spring Loaded knee brace versus other knee braces they had personally used. Participants consistently ranked a Spring Loaded knee brace as more effective.

Clinical study on Levitation 2 Knee brace at mccaig institute

Collaborators

Aleksandra Budarick

University of Waterloo

Budarick is currently pursuing her PhD in Health at Dalhousie University. Her research aims to understand interactions between clinical biomechanics, physical activity, and physical function in individuals with knee and hip osteoarthritis.

Dr. Emily Bishop

University of Calgary

Dr. Bishop is a postdoctoral fellow and clinical research associate for Spring Loaded. Based out of the McCaig Institute of Joint and Bone Health, where she works closely with patients to conduct clinical and biomechanical research on the Levitation knee brace.

Dr. Chris Cowper-Smith

Spring Loaded Technology

Dr. Cowper-Smith is a published and award-winning scientist and CEO of Spring Loaded Technology. He works closely with industry experts, researchers, clinicians, and patients to develop innovative products that have the potential to improve quality of life.

Partner Institutions

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.

Multiple Forces Reduced

Each TCO brace model significantly reduced PF, TF, PC ligament, PT and QT forces during a deep knee bend test.

Reduced Joint Load

Each TCO brace model significantly reduced knee joint loads by at least 32% when compared to the non-braced condition.

Replicates & Extends Previous Research

Results corroborate the knee joint offloading capabilities of a TCO, as demonstrated in a previous study (Budarick et al. 2020).

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