Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System

Last updated on July 2021

Conditions: Amputation
Type: Interventional
Phase: Not Applicable
Design: Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Multiple N-of-1 trial. : the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparatorMasking: None (Open Label)Masking Description: The medical device will be active (plugged) or inactive (unplugged), but the patient nor the investigator won't know if the medical device is active(plugged) or inactive (unplugged). After one-month accommodation period, patient will be randomly distributed into active or inactive vacuum 7 to 28 days phases with at least three phase change and a maximum of 50 days. The randomization will use a phase length ABAB randomization rather than block randomization commonly used in drug trials. However, because the patient has to come to the rehabilitation center at each phase change which would not allow the patient and the assessors to be blind to the next phase content, phases of a duration >14, will be further randomized into two half-phases of the same content with a placebo visit between the two half-phases, in order to keep the blinding. All sequences containing 3 true transition of activation/inactivation of the medical device and up to 3 placebo transitionsPrimary Purpose: Supportive Care

Not Provided