Single-Joint Type Hybrid Assistive Limb for Knee Training in the Acute Postoperative Phase After Opening Wedge High Tibial Osteotomy: A Feasibility and Safety Trial

Abstract

Background and objective: Opening wedge high tibial osteotomy (OWHTO) influences the knee extensor mechanism, the range of passive motion of knee extension and persistent quadriceps, and anterior knee pain and weakness. Rehabilitation should focus on quadriceps strength and improving joint mobility. The single-joint hybrid assistive limb device (HAL-SJ) is a wearable exoskeleton cyborg. In this study, we investigated the feasibility and safety of HAL-SJ training after the early postoperative period following OWHTO and whether the use of this device can improve functional outcomes, including knee muscle extensor strength and knee extension range of motion without knee pain.

Methods: Patients who had been diagnosed with knee osteoarthritis and had undergone OWHTO were assessed for eligibility in this prospective trial conducted at our institution between June 2015 and November 2020. The participants were split into two groups, i.e., 10 patients in the hybrid assistive limb (HAL) group and eight patients in the control group. We initiated HAL-SJ therapy on postoperative day 8 and continued it until the patient's discharge. During the hospitalization period, patients engaged in HAL-SJ-assisted knee extension exercises. This exercise routine encompassed five sets, each comprising 10 repetitions, and was conducted twice a week. We conducted assessments aimed at detecting any potential adverse events that could be linked to HAL training. Assessment of the knee extension angle via the visual analog scale (VAS) and strength assessments using a hand-held dynamometer (HHD) were conducted. To compare clinical outcomes before and after OWHTO, knee extension angle, the VAS, HHD, Japanese Orthopaedics Association (JOA) score, and the Japanese Knee Osteoarthritis Measure (JKOM) were assessed at four distinct time points.

Results: No adverse events were observed during the study. The assessment of clinical outcomes before and after OWHTO demonstrated a gradual improvement in outcomes.

Conclusion: The single-joint hybrid assistive limb device in patients who underwent OWHTO appears to be potentially safe. It contributed to enhanced muscle activity efficiency by reducing knee pain and improving knee extension angles in the early postoperative phase.

Keywords: feasibility and safety trial; knee extension angle; opening wedge high tibial osteotomy; the single-joint hybrid assistive limb; visual analogue scale.

Figure 1. Flow chart depicting the therapeutic intervention and assessments for each patient group

HAL: Hybrid assistive limb, HAL-SJ: Single-joint hybrid assistive limb device, VAS: Visual analog scale, HHD: Hand-held dynamometer, JOA: Japanese Orthopaedics Association, JKOM: Japanese Knee Osteoarthritis Measure

Figure 2. Breakdown of the results of the JOA score

JOA: Japanese Orthopaedics Association

Figure 3. Breakdown of the results of the JKOM score

JKOM: Japanese Knee Osteoarthritis Measure, ADL: Activities of daily living

Figure 4. The HHD assessments both before and after each HAL training session

HHD: Hand-held dynamometer, HAL: Hybrid assistive limb

Figure 5. A two-way mixed analysis of variance of the VAS score (from before the surgery to the day of discharge) between the HAL and control groups

VAS: Visual analog scale, HAL: Hybrid assistive limb

Figure 6. A two-way mixed analysis of variance and post hoc test of the knee extension angle (from before surgery to the day of discharge) between the HAL and control groups.

HAL: Hybrid assistive limb

Figure 7. Correlations between the VAS score and knee extension angle in both HAL and control groups in the first session (p < 0.05)

VAS: Visual analog scale, HAL: Hybrid assistive limb

Figure 8. Correlation between the VAS score and the HHD assessments for the HAL group in the first session (p < 0.05)

VAS: Visual analog scale, HHD: Hand-held dynamometer, HAL: Hybrid assistive limb

Figure 9. Correlation between the VAS score and the HHD assessments for the HAL group in the third session (p < 0.05)

VAS: Visual analog scale, HHD: Hand-held dynamometer, HAL: Hybrid assistive limb