Robotic-assistance in replantation of an amputated digit after trauma
Conditions
Interventions
Robotic-assisted anastomose during replantation of amputated digit after trauma
Sponsors
Maastricht University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - 18 years of age or older - Traumatic amputation of one or more digits; - Dutch resident (due to follow-up); - Time from trauma to presentation is less than 6 hours; - Amputated finger is feasible for replantation; - Patient request replantation over ‘simple’ wound repair with revision amputation.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Additional significant trauma that dictates other treatment priorities - Patient is not able to understand the study and consent for the operation - Current substance abuse; - Inability to replant the digit for any reason; - Unable to finish follow-up for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to study the applicability of robotic-assisted microsurgery in replantation of amputated digits due to trauma. The primary outcome will be the quality of the anastomoses using Structured Assessment of Microsurgery Skills (SAMS). | — |
Secondary
| Measure | Time frame |
|---|---|
| To provide important surgical and technical information, and to collect patient and surgeon satisfaction, the following secondary outcome measures are gathered: - Survival of the replanted digits; - Duration of surgery; - Adverse events, complications and robotic errors peri-operatively; - Post-operative complications and adverse events; - Surgeon’s satisfaction with the technique applied; - Patient’s satisfaction with the surgery procedure; - Function of the hand over time. | — |
Contacts
Public ContactA. Scharmga
MUMC
Outcome results
None listed