Thumb reconstruction after traumatic amputation: algorithm based treatment vs usual care: a multicentre randomized trial

Abstract

Background: Traumatic thumb amputation implies a big restriction of normal life activities owing to the main role of the thumb in hand basic movements as grasp or pinch. Appropriate thumb reconstruction is essential for a good quality of life and to minimize economic impact on patients. Several techniques have been developed and proven to be effective and safe but no criteria for the selection of the technique are stablished yet. Aim: The aim of this study is to assess whether the use of the algorithm-based treatment (Panu et al.) provides better overall hand function and post operative outcomes than usual care. Design: Multicentre, randomized, single-blind, parallel-group controlled trial. Patients, outcome assessors and statistician will be blind to group assignment and independent of treatment delivery. Setting: 5 hospitals of Girona province will be involved in an estimated duration of 4 years. Participants: Patients aged ≥ 18 years with acute traumatized non-replantable thumb. Patients will be excluded if they have other affected areas, previous congenital hand malformation or amputation of the injured hand, are not registered in the Catalan Health Service or cannot communicate in Spanish or Catalan. Intervention: 64 patients will be enrolled following a sampling method and randomly assigned in 1:1 ratio to the intervention group (algorithm-based treatment) or control group (usual care). Main outcome measures: The primary outcome is the hand function which will be measured through the overall hand function subscale of the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include post operative and recovery outcomes. Outcome assessment will be at 3 and 12 months post intervention. Analysis will be performed in an intention-to-treat basis