Investigating Lower Limb Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01691950
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : December 12, 2014
Engineering and Physical Sciences Research Council, UK
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Official Title: Investigating the Outcomes of Lower-limb Trauma Patients
Study Start Date : April 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Those who have undergone limb reconstruction following lower limb trauma
Those who have undergone amputation and rehabilitation with a prosthesis following lower limb trauma
Healthy volunteers

Primary Outcome Measures :
  1. Functional outcome (consisting of questionnaire score, Hamlyn Mobility Score (HMS) gait/activities of daily living parameters) [ Time Frame: Single Session (up to 1 hour) ]
    Participants will be given 3 functional outcome scores from a questionnaire, HMS, and objective kinematic measurements

Secondary Outcome Measures :
  1. Participant length of hospital stay, rehabilitation time (if appropriate), and complications. [ Time Frame: Up to length of study (1-2 years) ]
    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. Complications include those related to the lower limb trauma (no complications are likely to arise from the research study).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01691950

United Kingdom
Imperial College NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Engineering and Physical Sciences Research Council, UK
Principal Investigator: Richard M Kwasnicki, BSc (Hons) Imperial College London
Principal Investigator: Shehan Hettiaratchy, PhD, FRCS Imperial College London

Responsible Party: Imperial College London Identifier: NCT01691950     History of Changes
Other Study ID Numbers: CRO1934
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: March 2013

Keywords provided by Imperial College London:
Limb reconstruction
Functional outcome

Additional relevant MeSH terms:
Wounds and Injuries