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Frailty in patients undergoing major limb amputation for peripheral arterial disease

Frailty in patients undergoing major limb amputation for peripheral arterial disease: a retrospective cohort study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000522314
Enrollment
300
Registered
2017-04-10
Start date
2017-04-18
Completion date
2017-06-28
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Frailty is a multi-factorial concept encompassing the accumulated effects of comorbidity, mobility, social isolation, cognitive decline and poor nutritional status which build up with age. It is an increasing problem in our ageing population, and affects many outcomes following surgery. In patients undergoing major limb amputation, it is also likely to affect the ability to mobilise with a prosthetic limb. Little is known about which aspects of frailty are most important in patients undergoing major limb amputation. The aims of the project are: 1) Collect data on frailty-related factors in patients who have undergone major limb amputation, and information on outcomes, including whether the patient went on to successfully walk with a prosthesis. 2) Build statistical models to determine which factors are important in predicting outcomes. 3) Compare the performance of these models, which include specific measures of frailty, with generic models of outcome following major lower limb amputation.

Interventions

The frailty characteristics of patients undergoing major lower limb amputation at one of the hospitals run by Aneurin Bevan University Health Board in South East Wales from January 2010 until January 2017 will be recorded to determine the effects of frailty on outcome, and compared to established risk prediction models. We will record basic demographics, comorbidity (in the form of the Charlson Comorbidity Index), functional status (Katz score), residential status, Waterlow score, pre-operative

The frailty characteristics of patients undergoing major lower limb amputation at one of the hospitals run by Aneurin Bevan University Health Board in South East Wales from January 2010 until January 2017 will be recorded to determine the effects of frailty on outcome, and compared to established risk prediction models. We will record basic demographics, comorbidity (in the form of the Charlson Comorbidity Index), functional status (Katz score), residential status, Waterlow score, pre-operative blood tests and ECG, and pre-operative haemodynamics (highest heart rate and lowest blood pressure on the day of surgery). The Addenbrookes Vascular Frailty Score will be calculated, along with generic models for outcome following amputation. In all cases, pre-operative values will be collected.

Sponsors

Aneurin Bevan University Health Board
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients undergoing lower limb amputation above the ankle at any hospital in South East Wales overseen by Aneurin Bevan University Health Board between January 2010 and January 2017

Exclusion criteria

Patients having amputation at or below the ankle. Patients undergoing revision amputation which does not cross a major joint: for example a patient having revision of a below knee amputation to a shorter below knee amputation would be excluded, but a patient who has had a below knee amputation who has a revision to an above knee amputation need not be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026