Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784429
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2021-03-02
Brief Title:
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Sponsor:
Otto Bock Healthcare Products GmbH
Organization:
Otto Bock Healthcare Products GmbH
Study Overview
Official Title:
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASCENT K2
Brief 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 transfemoralknee disarticulation level amputation categorized as K2 ambulators
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None