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| Brief Title † | Temporary Prosthesis in Traumatic Below-Knee Amputation | ||||||||
| Official Title † | Immediate Temporary Prosthesis Fitting in Traumatic Trans-Tibial Amputation: a Controlled Clinical Study in Rural Cambodia | ||||||||
| Brief Summary | Most trauma survivors in low-income countries develop post-injury chronic pain syndromes. Normally traumatic amputees have to wait 4-6 months for definitive prostheis fitting. The actual study aims at reducing postinjury chronic pain and improving function by immediate temporary prostheis fitting after surgery. |
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| Detailed Description | Background: Previous studies document that 75% of traumatic amputees in low-income countries develop incapactiating chronic pain syndromes. With the present level of rehabilitation service, amputees have to wait 4-6 months for postoperative prosthesis fitting. Hypothesis: Immediate postoperative prosthesis fitting reduce chronic pain and improves function in trans-tibial amputees. Reference population: Traumatic amputees living in low-income and low-resource communities. Study population: Adult patients with transtibial amputations in rural districts of Battambang Province, Cambodia. Study design: A semi-cross over controlled study. Supplement:longitudinal qualitative studies of subsets. Main variables for quantitative study:
Sampling: Given test power =0.8, significance level =0.05, sequential analysis of results, an estimate of 15 patients will be included in each study group. The sample may be modified due to sequential analysis (see below). Intervention: A mobile rural workshop takes moulds and adapt temporary tuber-ischii bearing prosthesis made of local materials. The prosthesis is fitted at the time of amputation wound closure (5 - 15 days postinjury), and patients mobilized on walking aids. Control group patients comprise of transtibial amputees managed at neighboring hospitals not being served by the actual rehab workshop. Control patients leave hospital with walking aids without prosthesis. Data are gathered by rehab team (surgeon and prosthesis technician) at point zero, 1 month postop, 3 months postop. End-point for evaluation is 6 monmths post-op. Patients decide freely to cross-over on pain indications. Statistical analysis: Sequential design with positive and negative stopping rules. Outcome variables at end-point are reported for groups of 3 patients to statistician(Prof. Stig Larsen, University of Oslo) who gives stop orders. Ethical considerations: If ITP proves favourable, the study resultsd will be used to expand the rural rehab service to include control districts as well. This makes the use of control groups in the actual study legitimate. Also optional cross-over prevents agains inflicting unneccessary uncomfort in study patients. The study is approved by the local health authorities and Norwegian Committee for Research Ethics. The system for data filing and protection is approved by Norwegian Social Science Data Services, Bergen. Publication: Authoship will be set according to Vancouver regulations. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Pain: Patient-reated Pain: clinical exam rated Function: patient-rated Function: gait analysis |
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| Secondary Outcome Measure † | Qualitative longitudial study of subsets | ||||||||
| Condition † | Transtibial Amputation | ||||||||
| Intervention † | Device: Temporary tuber-ischii bearing prosthesis | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 20 | ||||||||
| Start Date † | March 2006 | ||||||||
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| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
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| Location Countries † | Cambodia | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00263497 | ||||||||
| Organization ID | KHM1030375 | ||||||||
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| Study Sponsor † | University Hospital of North Norway | ||||||||
| Collaborators †† | Medical University of Joenkoeping, Sweden NCHADS - Ministry of Health of Cambodia |
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| Information Provided By | University Hospital of North Norway | ||||||||
| Verification Date | December 2005 | ||||||||
| First Received Date † | December 7, 2005 | ||||||||
| Last Updated Date | December 7, 2005 | ||||||||
