Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT04120558
Status:
UNKNOWN
Last Update Posted:
2022-07-21
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing OutcomeS of Through Knee and Above Knee Amputation
Sponsor:
Hull University Teaching Hospitals NHS Trust
Organization:
Study Overview
Official Title:
Comparing OutcomeS of Through Knee and Above Knee Amputation (COSTAA)
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
COSTAA
Brief Summary:
Major lower limb amputation is a life changing surgical procedure to treat complications of diabetes mellitus and peripheral vascular disease. The level of function after amputation is dependent on pre-morbid levels of activity, age, co-morbidities and the level of amputation. The level of amputation performed is determined by level of disease and surgical assessment. Below knee amputation provides the best functional outcomes due to the benefits of keeping the knee intact. When a below knee amputation is not possible, routine practice is to perform an above knee amputation. Greater challenges for rehabilitation present at this level due to the shorter lever. Amputation through the knee is less commonly performed despite its reported benefits which include a long mechanical lever arm, an endbearing stump and greater muscle control.
A recent systematic review recommends further comparison of through knee and above knee amputation. The recommended areas of research are gait biomechanics and quality of life for these patient groups. Therefore, the aim of this research is to compare and contrast the long-term functional mobility and quality of life outcomes of limb wearing through knee and above knee amputees. The study will be split into two workstreams, the first focusing on functional outcomes and the second focusing on quality of life using semi-structured interviews.
A recent systematic review recommends further comparison of through knee and above knee amputation. The recommended areas of research are gait biomechanics and quality of life for these patient groups. Therefore, the aim of this research is to compare and contrast the long-term functional mobility and quality of life outcomes of limb wearing through knee and above knee amputees. The study will be split into two workstreams, the first focusing on functional outcomes and the second focusing on quality of life using semi-structured interviews.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: