Temporary Prosthesis in Traumatic Below-knee Amputation

NCT ID: NCT00263497

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2020-03-31

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.

Conditions

Transtibial Amputation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Traumatic transtibial amputation

Exclusion Criteria

• Double amputation

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Joenkoeping, Sweden

OTHER

Sponsor Role: collaborator

NCHADS - Ministry of Health of Cambodia

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bjoern Karlsson, Rehab Ing

Role: PRINCIPAL_INVESTIGATOR

TMC, University Hospital Northern Norway

Locations

Trauma Care Foundation Cambodia

Battambang, , Cambodia

Countries

Cambodia

Other Identifiers

KHM1030375

Identifier Type: -

Identifier Source: org_study_id