Investigating Lower Limb Trauma
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 23, 2012 | ||||||||
| Last Updated Date | March 26, 2013 | ||||||||
| Start Date ICMJE | April 2012 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01691950 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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). |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Investigating Lower Limb Trauma | ||||||||
| Official Title ICMJE | Investigating the Outcomes of Lower-limb Trauma Patients | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE | Trauma | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | July 2014 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01691950 | ||||||||
| Other Study ID Numbers ICMJE | CRO1934 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Imperial College London | ||||||||
| Study Sponsor ICMJE | Imperial College London | ||||||||
| Collaborators ICMJE | Engineering and Physical Sciences Research Council, UK | ||||||||
| Investigators ICMJE |
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| Information Provided By | Imperial College London | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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