Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263497
Status:
TERMINATED
Last Update Posted:
2020-03-10
First Post:
2005-12-07
Brief Title:
Temporary Prosthesis in Traumatic Below-knee Amputation
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Immediate Temporary Prosthesis Fitting in Traumatic Trans-tibial Amputation a Controlled Clinical Study in Rural Cambodia
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No update for several year confermed ended by Odd Edvardsen i march 2020
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 prosthesis fitting The actual study aims at reducing post-injury chronic pain and improving function by immediate temporary prosthesis fitting after surgery
Detailed Description:
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 Supplementlongitudinal qualitative studies of subsets
Main variables for quantitative study
Outcome indicatorsSelf-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 08 significance level 005 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 statisticianProf 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
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 Supplementlongitudinal qualitative studies of subsets
Main variables for quantitative study
Outcome indicatorsSelf-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 08 significance level 005 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 statisticianProf 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None