Mitigating Hip Injuries in High-Risk Older Adults: Clinical Evidence Supporting FDA Approval of a Novel Wearable...

To evaluate the effectiveness of a wearable airbag belt in preventing fall-related hip injuries among older adults at high risk for injurious falls in older adult care settings.

Six-month, nonrandomized controlled trial with propensity-matched historical controls and blinded outcome assessment (NCT05245097).

Study conducted across 11 older adult residential facilities in the United States, including 134 intervention participants wearing the Tango Belt and 264 matched historical controls. Participants were aged ≥65 years, able to transfer/ambulate with assistance ranging from independent to extensive assistance, and at high risk for fall injuries based on fall fracture history or fall history with bone loss.

Intervention participants wore the Tango Belt, a device using motion sensors to detect serious hip-impacting falls and deploy airbag protection, in addition to standard of care (SOC) for fall prevention. Controls received SOC alone. The primary outcome was major hip injuries due to serious hip-impacting falls over 6 months, adjudicated by a geriatrician blinded to group assignment. Secondary outcomes included fall-related hip fractures, emergency department visits, and hospitalizations.

The intervention group experienced significantly fewer major hip injuries from serious hip-impacting falls [1.1% vs 12.1%, relative risk (RR), 0.091; 95% CI, 0.0-3.9; P < .004], fall-related hip fractures (2.2% vs 11.4%, RR, 0.19; 95% CI 0.5-6.4; P = .003), emergency department visits (6.0% vs 17.8%, RR, 0.34; 95% CI, 2.6-11.4; P ≤ .001), and hospitalizations (8.2% vs 18.9%, RR, 0.43; 95% CI, 4.2-14.2; P = .003) compared with controls. Overall fall rates did not differ significantly between intervention and control groups (1.56 vs 1.31 falls per 180 days, respectively; P = .075). Overall adherence in the intention-to-treat group was 67% of possible wear days with a median device wear time of 8.8 hours daily on days worn. The device detected and deployed during 6 serious hip-impacting falls with no associated hip injuries.

The wearable airbag belt significantly reduced fall-related hip injuries and associated health care utilization in high-risk older adults. These results suggest that wearable fall injury protection technology may provide an effective complement to existing fall prevention strategies in the older adult population.