NCT04120558: COSTAA

Comparing OutcomeS of Through Knee and Above Knee Amputation

Status unknown Last updated 21 July 2022

What this trial tests

trial testing Qualitative interviews and focus groups in Through Knee Amputation in 40 participants. Status unknown.

Timeline

5 June 2019

Primary endpoint
30 April 2022

31 October 2022

Quick facts

Lead sponsor	Hull University Teaching Hospitals NHS Trust
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	40
Start date	5 June 2019
Primary completion	30 April 2022
Estimated completion	31 October 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Qualitative interviews and focus groups
• Functional mobility tests and questionnaires

Conditions studied

• Through Knee Amputation — all drugs for Through Knee Amputation →

Sponsor

Hull University Teaching Hospitals NHS Trust

Who can join

18 and older, any sex, with Through Knee Amputation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Through-knee versus above-knee amputation for vascular and non-vascular major lower limb amputations.
   Crane H, Boam G, Carradice D, Vanicek N, et al · · 2021 · cited 15× · PMID 34904714 · DOI 10.1002/14651858.cd013839.pub2