Investigating Lower Limb Trauma
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Purpose
This is an observational study, which aims to compare the outcomes of patients who undergo amputation with those who have limb salvage surgery following a traumatic injury to their lower limb.
| Condition |
|---|
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Trauma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Investigating the Outcomes of Lower-limb Trauma Patients |
- Functional outcome (consisting of questionnaire score, Functional Mobility Assessment (FMA) score, gait/activities of daily living parameters) [ Time Frame: Single Session (up to 1 hour) ] [ Designated as safety issue: No ]Participants will be given 3 functional outcome scores from a questionnaire, FMA, 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) ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Reconstruction
Those who have undergone limb reconstruction following lower limb trauma
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Prosthesis
Those who have undergone amputation and rehabilitation with a prosthesis following lower limb trauma
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Control
Healthy volunteers
|
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 scientific validity, and therefore may not be truly representative of functional outcome.
The investigators plan on using objective measures for assessing functional outcome in 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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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:
- Contralateral (or other) limb impairment
- 18 > AGE > 65
- Currently a hospital inpatient
- Psychological disorder
Contacts and Locations| Contact: Richard M Kwasnicki, BSc (Hons) | 07851759471 | rmk107@ic.ac.uk |
| United Kingdom | |
| Imperial College NHS Trust | Recruiting |
| London, United Kingdom, W2 1NY | |
| Contact: Richard M Kwasnicki, BSc (Hons) rmk107@ic.ac.uk | |
| Principal Investigator: | Richard M Kwasnicki, BSc (Hons) | Imperial College London |
| Principal Investigator: | Shehan Hettiaratchy, PhD, FRCS | Imperial College London |
More Information
No publications provided
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01691950 History of Changes |
| Other Study ID Numbers: | CRO1934 |
| Study First Received: | April 23, 2012 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: National Health Service |
Keywords provided by Imperial College London:
|
Trauma Limb reconstruction Amputation Functional outcome Sensing |
Additional relevant MeSH terms:
|
Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013