Temporary Prosthesis in Traumatic Below-knee Amputation
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|ClinicalTrials.gov Identifier: NCT00263497|
Recruitment Status : Terminated (No update for several year, confermed ended by Odd Edvardsen i march 2020.)
First Posted : December 8, 2005
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Transtibial Amputation||Device: Temporary tuber-ischii bearing prosthesis||Not Applicable|
Background: Previous studies document that 75% of traumatic amputees in low-income countries develop incapacitating 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 trans-tibial 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:
- Outcome indicators:Self-rated pain (VAS). Self-rated function (VAS). Pain (clinical exam). Gait analysis.
- Variables: Preinjury morbidity and socioeconomical status. Injury severity (RTS, ISS). Prehospital and hospital analgesia. Postoperative infection. Amputation stump quality (clinical rating).
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 molds 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 post-injury), 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 postoperation, 3 months postoperation. End-point for evaluation is 6 months 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 favorable, the study results 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 against inflicting unnecessary discomfort 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: Authorship will be set according to Vancouver regulations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immediate Temporary Prosthesis Fitting in Traumatic Trans-tibial Amputation: a Controlled Clinical Study in Rural Cambodia|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||March 2020|
|Actual Study Completion Date :||March 2020|
- Device: Temporary tuber-ischii bearing prosthesis
Tuber ischii-bearing holster is connected by hinged metal bars to foot device to enable immediate postoperative mobilization of transtibial amputees. No other medical interventions or pharmaceutical treatment.
- Pain: Patient-rated [ Time Frame: 1, 3, and 6 months postinjury ]
- Pain: clinical exam rated [ Time Frame: 1, 3, and 6 months post-injury ]
- Function: patient-rated [ Time Frame: 1, 3, and 6 months post-injury ]
- Function: gait analysis [ Time Frame: 1, 3, and 6 months post-injury ]
- Qualitative longitudinal study of subsets [ Time Frame: 1, 3, and 6 months post-injury ]
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): NCT00263497
|Trauma Care Foundation Cambodia|
|Battambang, Cambodia, 9500|
|Principal Investigator:||Bjoern Karlsson, Rehab Ing||TMC, University Hospital Northern Norway|