Temporary Prosthesis in Traumatic Below-knee Amputation

Immediate Temporary Prosthesis Fitting in Traumatic Trans-tibial Amputation: a Controlled Clinical Study in Rural Cambodia

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.

Study Overview

• Status: Terminated
• Conditions: Transtibial Amputation
• Intervention / Treatment: 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
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cambodia
  • Battambang, Cambodia, 9500
    • Trauma Care Foundation Cambodia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Traumatic transtibial amputation

Exclusion Criteria:

• Double amputation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain: Patient-rated	1, 3, and 6 months postinjury
Pain: clinical exam rated	1, 3, and 6 months post-injury
Function: patient-rated	1, 3, and 6 months post-injury
Function: gait analysis	1, 3, and 6 months post-injury

Secondary Outcome Measures

Outcome Measure	Time Frame
Qualitative longitudinal study of subsets	1, 3, and 6 months post-injury

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: NCHADS - Ministry of Health of Cambodia; Medical University of Joenkoeping, Sweden
• Investigators: Principal Investigator: Bjoern Karlsson, Rehab Ing, TMC, University Hospital Northern Norway

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 7, 2005
• First Submitted That Met QC Criteria: December 7, 2005
• First Posted (Estimate): December 8, 2005

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Physical rehabilitation; Postinjury chronic pain; Transtibial amputation; Immediate temporary prosthesis
• Other Study ID Numbers: KHM1030375