Stance-Control Knee-Ankle-Foot Orthoses for People With Knee Instability: A Health Technology Assessment.

Background: Knee instability can arise from various causes and conditions such as neuromuscular disease, central nervous system conditions, and trauma. For people with knee instability, knee orthosis devices are prescribed to help with standing, walking, and performing tasks. We conducted a health technology assessment of stance-control knee-ankle-foot orthoses (SCKAFOs) for people with knee instability, which included an evaluation of the effectiveness, safety, and budget impact of publicly funding SCKAFOs, as well as patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias in Nonrandomized Studies (RoBANS) tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and also analyzed the budget impact of publicly funding SCKAFOs in people with knee instabilities in Ontario. We did not conduct a primary economic evaluation as there was limited comparative clinical evidence to inform an economic model. Our reference case budget impact analysis was done from the perspective of the Ontario Ministry of Health; it compared the total costs of a basic mechanical SCKAFO and locked KAFO (LKAFO) for people with knee instability. We also performed scenario analyses varying the following parameters: the price of all classes of SCKAFO (mechanical, electronic, and microprocessor), and the uptake of SCKAFO. To contextualize the potential value of SCKAFO, we spoke with people with knee instability.

Results: We included four studies in the clinical evidence review. We are uncertain if SCKAFOs improve walking ability, energy consumption, or activities of daily living compared with LKAFOs (GRADE: Very low). Our economic evidence review identified one costing analysis that suggested that the costs of orthotic devices such as LKAFOs and SCKAFOs are highly variable according to the cost of materials, professional time, and customization required by the individual patient. The budget impact of publicly funding mechanical SCKAFOs in Ontario over the next 5 years (at a full device cost of $10,784) ranged from an additional $0.50 million in year 1 (at an uptake rate of 30% in the target population [429 eligible people]) to $0.83 million in year 5 (at an uptake rate of 50%), with a total budget impact of $3.34 million over 5 years. We found that the greatest increase in budget impact in the scenario analysis came from the microprocessor SCKAFO device, which had an additional cost of $10.07 million in year 1, increasing to $16.78 million in year 5. When we decreased the cost of a mechanical SCKAFO device (to $7,384), this reduced the 5-year budget impact to $0.89 million (vs. $3.34 million in the reference case). The people with knee instability with whom we spoke reported that they preferred a device that would provide a more typical gait, but starting with this type of device would be easier than switching from an existing LKAFO.

Conclusions: We are uncertain if SCKAFOs improve walking ability, reduce energy consumption, or improve activities of daily living compared with LKAFOs. We estimate that the additional cost to provide public funding for a mechanical SCKAFO in people with knee instability would range from about $0.50 million in year 1 to $0.83 million in year 5, yielding a total budget impact of $3.34 million over 5 years. Depending on the class of SCKAFO and the uptake rate for the device, the budget impact may vary. People who met the criteria for the use of a SCKAFO did have a strong preference for it over an LKAFO.