Clinical trial NCT04120558: Comparing OutcomeS of Through Knee and Above Knee Amputation
Official title: Comparing OutcomeS of Through Knee and Above Knee Amputation (COSTAA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Through Knee Amputation
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2019-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community dwelling adults with through knee or above knee amputation of all mobility levels.

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.


Eligibility criteria: Inclusion Criteria:

* Community dwelling adults aged 18 or over.
* People who have had either a through-knee or above-knee amputation.
* Unilateral amputees.
* English speaking and cognitively be able to follow instructions and fill out questionnaires independently.

Exclusion Criteria:

* People are unable to provide an informed consent.
* People who have a below-knee amputation.
* Unable to transfer with assistance of one.
* Unable to walk more than 5 metres (ambulatory section workstream 1 only).
* Individuals will be excluded from workstream 2 if they report another health condition with greater impact on their quality of life than their amputation.

Primary outcomes:
measure: The primary outcomes measure for workstream 1 is walking speed.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The primary outcome measure for workstream 2 is an in-depth analysis and comparison of quality of life.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: The secondary outcome measures for workstream 1 include time taken.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include distance reached.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include distance walked. [
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include step count.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include predicted 6MWT score.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include time taken to stand from sitting.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include time taken to sit from standing.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include walking time.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include functional balance.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include function during sitting.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include step length and height.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include step symmetry.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include falls risk using the Tinetti assessment.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include recording of confidence levels using the Activity Balance Confidence (ABC-UK) questionnaire.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include confidence levels using the Locomotor-Capabilities Index-5 (LCI-5) questionnaire.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include confidence levels using the Short Form Survey Instrument (SF36)
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include confidence levels using Houghton's Scale of Prosthetic Use.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 1 include confidence levels using the EuroQol EQ-5D-5L questionnaire.
timeFrame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
measure: The secondary outcome measures for workstream 2 are the lived experiences, processes of adjustment, body image, satisfaction with prosthesis and overall quality of life differences between the through knee and above knee amputees.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
state: East Riding Of Yorkshire
Study officials:
References: