Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population (ASCENT K2)

Otto Bock Healthcare (Ottobock)

Status: Active, not recruiting

Conditions: Lower Limb Amputation Knee; Congenital Amputation of Lower Limb; Lower Limb Amputation Above Knee (Injury)

Treatments: Device: Kenevo or C-Leg 4; Device: Non microprocessor controlled knee (NMPK)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04784429

OB113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral transfemoral or knee disarticulation amputation
• Received prosthesis between 4 - 24 months prior
• Currently uses prosthesis
• K2 ambulator status
• Able to speak English or Spanish language
• Age ≥ 65 years at Baseline Assessment (one month after enrollment)
• Minimum Socket Comfort Score (SCS) of 6/10

Exclusion criteria

• Upper limb involvement
• Individuals ≥ 275 lbs
• Unable to provide informed consent
• History of acute or chronic residual limb breakdown
• History of 2 or more socket adjustments or replacements in the past 6 months
• Amputation of the contralateral limb
• Active malignancy
• Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical & Scientific Affairs personnel
• Patient unable or unwilling to follow study procedures
• Pregnant women, institutionalized persons, and children

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

107 participants in 2 patient groups

MPK

Experimental group

Description:

Microprocessor controlled knee

Treatment:

Device: Kenevo or C-Leg 4

NMPK

Active Comparator group

Description:

Non-microprocessor controlled knee

Treatment:

Device: Non microprocessor controlled knee (NMPK)