Through Knee AmputationCOSTAANCT04120558
Comparing OutcomeS of Through Knee and Above Knee Amputation
An observational study of Through Knee Amputation, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Through Knee Amputation
- What is being tested?
- Qualitative interviews and focus groups and Functional mobility tests and questionnaires
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jun 2019to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community dwelling adults with through knee or above knee amputation of all mobility levels.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull University Teaching Hospitals NHS Trust
Hull, East Riding Of Yorkshire, HU3 2JZ
About this study
Official title: Comparing OutcomeS of Through Knee and Above Knee Amputation (COSTAA)
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.
- Conditions
- Through Knee Amputation
- Being tested
- Qualitative interviews and focus groups, Functional mobility tests and questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviews and focus groupsOther
Semi-structured interviews will be undertaken with at least 24 and up to as many as 36 through knee and above knee amputees. A topic guide will be used to interview participants about perceived functional ability, body image, adapting post amputation and overall quality of life. A sampling frame will be used to ensure a range of views are sought (e.g. both men and women with through and above knee amputations; and with different mobility levels). Thematic analysis will be used to analyse the data. Focus group discussions will be informed by the findings of the interviews.
The themes that emerge from the semi-structured interviews will be further explored using focus groups and allow for comparison of the experiences between through knee and above knee amputees.
Functional mobility tests and questionnairesOther
Function in sitting and sit-and-reach will be assessed in non-ambulatory (wheelchair users) individuals. An overall score for each sitting activity will be recorded and the distance reached will be calculated.
Walking, timed-up-and-go, L-test, balance in sitting and standing, seated activities will be assessed in ambulatory (prosthetic using) individuals. The time taken, distance walked, distance reached, and the overall scores for each activity will be compared between the two groups. Fear of falls and confidence levels when performing tasks will be investigated using two questionnaires.
The EQ-5D-5L and SF-36 will be issued to the non-ambulatory and ambulatory participants to complete when attending the testing session.
The Locomotor Capability Index - 5 (LCI-5), Activities-specific Balance Confidence Scale (ABC-UK) and Houghton scale of prosthetic use in people with lower-extremity amputations
| Study group | Role | What they receive |
|---|---|---|
| Through knee amputees | Community dwelling individuals with through knee amputation of all mobility levels. Receives: Other: Qualitative interviews and focus groups; Other: Functional mobility tests and questionnaires | |
| Above knee amputees | Community dwelling individuals with above knee amputation of all mobility levels. Receives: Other: Qualitative interviews and focus groups; Other: Functional mobility tests and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes measure for workstream 1 is walking speed.
Walking speed will be determined as distance divided by time in seconds and will be calculated during timed-up-and-go test, L-test, two-minute walk test (2MWT) and six-minute walk test (6MWT). The results will be presented as metres per second
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The primary outcome measure for workstream 2 is an in-depth analysis and comparison of quality of life.
The analysis of semi-structured interviews and focus groups using a self designed topic guide with questions relating to quality of life.
Measured: Through study completion, an average of 1 year
Secondary outcomes (19)
The secondary outcome measures for workstream 1 include time taken.
Time taken will be calculated as the time in seconds calculated during timed-up-and-go test and L-test.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include distance reached.
Distance reached will be calculated as the distance reached in centimetres calculated during the functional reach test, and the sit-and-reach test.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include distance walked. [
Distance walked will be calculated as the distance in metres calculated during the 2MWT and 6MWT.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include step count.
Step count will be calculated as the number of steps taken during timed-up-and-go test, L-test, 2MWT and 6MWT.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include predicted 6MWT score.
Predicted 6MWT score will be calculated as the distance walked in the 2MWT multiplied by 3.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include time taken to stand from sitting.
The time taken to stand from sitting will be calculated as the time in seconds taken from the participant moving from a seated to standing position. This will be calculated during the Timed-Up-and-Go test and the L-test.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include time taken to sit from standing.
The time taken to sit from standing will be calculated as the time in seconds taken from the participant moving from a standing to seated position. This will be calculated during the Timed-Up-and-Go test and the L-test.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include walking time.
The walking time will be calculated as the time in seconds spent walking to and from the chair. This will be calculated during the Timed-Up-and-Go test and the L-test.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include functional balance.
Functional balance will be calculated as the overall score from their observed performance across 14 activities when completing the Berg Balance scale.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include function during sitting.
Function during sitting will be calculated as the overall score from their observed performance across 14 activities when completing the function in sitting test.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include step length and height.
Step length and height will be observed and recorded as part of the Tinetti assessment.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include step symmetry.
Step symmetry will be observed and recorded as part of the Tinetti assessment.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include falls risk using the Tinetti assessment.
Falls risk will be calculated as the overall score from their observed performance out of 28 when completing the Tinetti assessment.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include recording of confidence levels using the Activity Balance Confidence (ABC-UK) questionnaire.
Confidence levels will be calculated using the Activity-Balance Confidence (ABC-UK) questionnaire.
Items are rated on a scale 0-100, 0 represents no confidence and 100 represents complete confidence when performing activities.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include confidence levels using the Locomotor-Capabilities Index-5 (LCI-5) questionnaire.
Confidence levels will be calculated using the Locomotor-Capabilities Index-5 (LCI-5) questionnaire. Items are scored on a 4 point scale ranging from 0 = not able to accomplish activity alone 3= being able to accomplish the activity alone.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include confidence levels using the Short Form Survey Instrument (SF36)
Confidence levels will be calculated using the Short Form Survey Instrument (SF36). Items are scored using Likert scale and yes/no options. Scales are standardised with a scoring algorithm to obtain a score ranging from 0-100. High scores indicate better health status.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include confidence levels using Houghton's Scale of Prosthetic Use.
Confidence levels will be calculated using Houghton's Scale of Prosthetic Use. This is a 4 item instrument to capture prosthetic wearing habits. Users will have a total score out of 12 where a high score indicates great performance and great comfort. The first 3 items are scored on a 4 point scale ranging from 0-3 where 0=low level of confidence and 3 = high level of confidence. The 4th item is a yes/no question relating to stability where yes scores 0 and No scores 1.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include confidence levels using the EuroQol EQ-5D-5L questionnaire.
Confidence levels will be calculated using the EQ-5D-5L questionnaire. EQ-5D-5L is a standardized instrument for measuring generic health and mobility. Scores are calculated using a likert scale 1-5 to indicate levels of severity where 1 = no problems and 5 = high level of problems. The EQ-5D-5L also includes a Visual Analogue Scale (EQ-VAS) score, users rate their perception of their health on a scale of 0-100 where 0=worst and 100=best health.
Measured: Measures taken at baseline visit, data reported through study completion, an average of 1 year
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.
The analysis of semi-structured interviews and focus groups using a topic guide with self-designed questions relating to the lived experiences, processes of adjustment, body image, satisfaction with prosthesis.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start5 Jun 2019
- Primary completion30 Apr 2022
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Through Knee AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120558
- Sponsor's protocol ID
- R2378
- Acronym
- COSTAA
- Status last verified
- Jul 2022
- First submitted
- 26 Sep 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing OutcomeS of Through Knee and Above Knee Amputation (COSTAA)
- ClinicalTrials.gov ID
- NCT04120558
- Acronym / sponsor ID
- COSTAA / R2378
- Conditions
- Through Knee Amputation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Through knee amputees | – | Other: Qualitative interviews and focus groups, Other: Functional mobility tests and questionnairesCommunity dwelling individuals with through knee amputation of all mobility levels. |
| Above knee amputees | – | Other: Qualitative interviews and focus groups, Other: Functional mobility tests and questionnairesCommunity dwelling individuals with above knee amputation of all mobility levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling adults with through knee or above knee amputation of all mobility levels.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative interviews and focus groupsSemi-structured interviews will be undertaken with at least 24 and up to as many as 36 through knee and above knee amputees. A topic guide will be used to interview participants about perceived functional ability, body image, adapting post amputation and overall quality of life. A sampling frame will be used to ensure a range of views are sought (e.g. both men and women with through and above knee amputations; and with different mobility levels). Thematic analysis will be used to analyse the data. Focus group discussions will be informed by the findings of the interviews. The themes that emerge from the semi-structured interviews will be further explored using focus groups and allow for comparison of the experiences between through knee and above knee amputees. | Other | Above knee amputees, Through knee amputees |
| Functional mobility tests and questionnairesFunction in sitting and sit-and-reach will be assessed in non-ambulatory (wheelchair users) individuals. An overall score for each sitting activity will be recorded and the distance reached will be calculated. Walking, timed-up-and-go, L-test, balance in sitting and standing, seated activities will be assessed in ambulatory (prosthetic using) individuals. The time taken, distance walked, distance reached, and the overall scores for each activity will be compared between the two groups. Fear of falls and confidence levels when performing tasks will be investigated using two questionnaires. The EQ-5D-5L and SF-36 will be issued to the non-ambulatory and ambulatory participants to complete when attending the testing session. The Locomotor Capability Index - 5 (LCI-5), Activities-specific Balance Confidence Scale (ABC-UK) and Houghton scale of prosthetic use in people with lower-extremity amputations | Other | Above knee amputees, Through knee amputees |
Primary outcome
The primary outcomes measure for workstream 1 is walking speed.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
Walking speed will be determined as distance divided by time in seconds and will be calculated during timed-up-and-go test, L-test, two-minute walk test (2MWT) and six-minute walk test (6MWT). The results will be presented as metres per second
The primary outcome measure for workstream 2 is an in-depth analysis and comparison of quality of life.
Time frame: Through study completion, an average of 1 year
The analysis of semi-structured interviews and focus groups using a self designed topic guide with questions relating to quality of life.
19 secondary outcomes
The secondary outcome measures for workstream 1 include time taken.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include distance reached.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include distance walked. [
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include step count.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include predicted 6MWT score.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include time taken to stand from sitting.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include time taken to sit from standing.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include walking time.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include functional balance.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include function during sitting.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include step length and height.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include step symmetry.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include falls risk using the Tinetti assessment.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include recording of confidence levels using the Activity Balance Confidence (ABC-UK) questionnaire.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include confidence levels using the Locomotor-Capabilities Index-5 (LCI-5) questionnaire.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include confidence levels using the Short Form Survey Instrument (SF36)
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include confidence levels using Houghton's Scale of Prosthetic Use.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
The secondary outcome measures for workstream 1 include confidence levels using the EuroQol EQ-5D-5L questionnaire.
Time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Through Knee Amputation, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcomes measure for workstream 1 is walking speed. (time frame: Measures taken at baseline visit, data reported through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.