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Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population — ASCENT K2  

Lower Limb Amputation Above Knee (Injury) Clinical Trial

Official title:
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Clinical Trial Summary

Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.

Clinical Trial Description

Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04784429
Study type Interventional
Source Otto Bock Healthcare Products GmbH
Contact
Status Active, not recruiting
Phase N/A
Start date June 11, 2021
Completion date December 31, 2026
View Details
See also
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