Clinical trial NCT01691950: Investigating Outcomes of Lower Limb Trauma
Official title: Investigating the Outcomes of Lower-limb Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: Trauma
Limb reconstruction
Amputation
Functional outcome
Sensing
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Engineering and Physical Sciences Research Council, UK
First posted: 2012-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been treated following lower limb trauma at the Imperial College NHS Trust sites will be recruited for this study.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters)
timeFrame: 3 months post-reconstruction
Secondary outcomes:
measure: Participant Length of Hospital Stay
timeFrame: Up to length of study (1-2 years)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College NHS Trust
Study officials:
affiliation: Imperial College London
name: Richard M Kwasnicki, BSc (Hons)
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Shehan Hettiaratchy, PhD, FRCS
role: PRINCIPAL_INVESTIGATOR
References: