Investigating Lower Limb Trauma
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|ClinicalTrials.gov Identifier: NCT01691950|
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : December 12, 2014
|Condition or disease|
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|
|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|
Those who have undergone limb reconstruction following lower limb trauma
Those who have undergone amputation and rehabilitation with a prosthesis following lower limb trauma
- 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
- 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).
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 ClinicalTrials.gov identifier (NCT number): NCT01691950
|Imperial College NHS Trust|
|London, United Kingdom, W2 1NY|
|Principal Investigator:||Richard M Kwasnicki, BSc (Hons)||Imperial College London|
|Principal Investigator:||Shehan Hettiaratchy, PhD, FRCS||Imperial College London|