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Temporary Prosthesis in Traumatic Below-knee Amputation

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ClinicalTrials.gov Identifier: NCT00263497
Recruitment Status : Unknown
Verified May 2012 by University Hospital of North Norway.
Recruitment status was:  Recruiting
First Posted : December 8, 2005
Last Update Posted : May 14, 2012
Medical University of Joenkoeping, Sweden
NCHADS - Ministry of Health of Cambodia
Information provided by (Responsible Party):
University Hospital of North Norway

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.

Condition or disease Intervention/treatment
Transtibial Amputation Device: Temporary tuber-ischii bearing prosthesis

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. 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
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Temporary Prosthesis Fitting in Traumatic Trans-tibial Amputation: a Controlled Clinical Study in Rural Cambodia
Study Start Date : March 2006
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

Intervention Details:
    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.

Primary Outcome Measures :
  1. Pain: Patient-rated [ Time Frame: 1, 3, and 6 months postinjury ]
  2. Pain: clinical exam rated [ Time Frame: 1, 3, and 6 months post-injury ]
  3. Function: patient-rated [ Time Frame: 1, 3, and 6 months post-injury ]
  4. Function: gait analysis [ Time Frame: 1, 3, and 6 months post-injury ]

Secondary Outcome Measures :
  1. Qualitative longitudinal study of subsets [ Time Frame: 1, 3, and 6 months post-injury ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Traumatic transtibial amputation

Exclusion Criteria:

  • Double amputation

Information from the National Library of Medicine

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

Contact: Hans Husum, PhD +47 95171710 tmc@unn.no
Contact: Odd Edvardsen, MPH +47 776 26227 tmc@unn.no

Trauma Care Foundation Cambodia Recruiting
Battambang, Cambodia, 9500
Contact: Yang V Heng, MPH    +855 1288 9094    tcf@camintel.com   
Principal Investigator: Phoun Sambath, MD         
Sponsors and Collaborators
University Hospital of North Norway
Medical University of Joenkoeping, Sweden
NCHADS - Ministry of Health of Cambodia
Principal Investigator: Bjoern Karlsson, Rehab Ing TMC, University Hospital Northern Norway

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00263497     History of Changes
Other Study ID Numbers: KHM1030375
First Posted: December 8, 2005    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by University Hospital of North Norway:
Postinjury chronic pain
Transtibial amputation
Physical rehabilitation
Immediate temporary prosthesis