Investigating Outcomes of Lower Limb Trauma

Trauma Clinical Trial

Official title:

Investigating the Outcomes of Lower-limb Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691950
• Other study ID #: CRO1934
• Status: Completed
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: February 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
United Kingdom	Imperial College NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Engineering and Physical Sciences Research Council, UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters)	The Hamlyn Mobility Score is a measure of functional mobility as measured by a wearable sensors during simple physical activities. The score range is from 0 - 60, with 60 being the best score possible and represents normal physical function of a healthy adult.	3 months post-reconstruction
Secondary	Participant Length of Hospital Stay	These measurements refer to the participants healthcare journey (which are not affected by the research project). Hospital stay refers to the time around their lower limb trauma and any further admissions.	Up to length of study (1-2 years)