Investigating Outcomes of Lower Limb Trauma

Imperial College London

Status: Completed

Conditions: Trauma

Study type: Observational

Funder types: Other

Identifiers

NCT01691950

CRO1934

Details and patient eligibility

About

This is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. This will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb salvage surgery following a traumatic injury to their lower limb.

Full description

In the setting of severe trauma, the decision whether to amputate or save a limb is common, and extremely difficult to make. Due to improving reconstructive surgical techniques there are currently no clear criteria for amputation. Although limb salvage appears desirable in most situations, numerous articles in the scientific literature have shown that it is associated with increased pain, complications, duration of hospital stay, rehabilitation time, and overall costs. These factors may be acceptable if the patients benefited from improved functional outcome. However, studies comparing amputation to limb salvage consistently report no significant difference in functional outcome between the two groups.

A major limitation in the methodology of the fore mentioned studies is the use of self-reported questionnaires to determine functional outcome. Questionnaires are subjective, and often lack specificity, and therefore may not be truly representative of functional outcome. Furthermore, lack of useful information during long-term post-operative care prevents adaption and optimisation of rehabilitation strategies.

The investigators plan on using a wearable sensor to develop an objective mobility assessment tool for patients having either amputation or limb salvage surgery after lower limb trauma. This would result in a reliable and accurate comparison, which may help healthcare professionals make an informed decision between amputation and limb salvage in the future.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• To have sustained a lower-limb trauma and undergone limb salvage surgery OR amputation with fitting of prosthesis

Exclusion criteria

1. Contralateral (or other) limb impairment
2. 18 > AGE > 65
3. Currently a hospital inpatient
4. Psychological disorder

Trial design

30 participants in 2 patient groups

Reconstruction

Description:

Those who have undergone limb reconstruction following lower limb trauma

Healthy volunteers

Description:

Healthy volunteers for control