Clinical trial NCT00263497: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transtibial Amputation
Keywords: Postinjury chronic pain
Transtibial amputation
Physical rehabilitation
Immediate temporary prosthesis
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Medical University of Joenkoeping, Sweden
name: NCHADS - Ministry of Health of Cambodia
First posted: 2005-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: Inclusion Criteria:

* Traumatic transtibial amputation

Exclusion Criteria:

* Double amputation

Primary outcomes:
measure: Pain: Patient-rated
timeFrame: 1, 3, and 6 months postinjury
measure: Pain: clinical exam rated
timeFrame: 1, 3, and 6 months post-injury
measure: Function: patient-rated
timeFrame: 1, 3, and 6 months post-injury
measure: Function: gait analysis
timeFrame: 1, 3, and 6 months post-injury
Secondary outcomes:
measure: Qualitative longitudinal study of subsets
timeFrame: 1, 3, and 6 months post-injury
Other outcomes:
Locations:
city: Battambang
country: Cambodia
facility: Trauma Care Foundation Cambodia
Study officials:
affiliation: TMC, University Hospital Northern Norway
name: Bjoern Karlsson, Rehab Ing
role: PRINCIPAL_INVESTIGATOR
References: