Robotic-assisted microsurgery in patients with digital nerve injuries; a feasibility study

Recruiting

Conditions: digital nerve repair
10009720

Registration Number: NL-OMON54692

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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 digital nerve injury (N. digitalis propria or N. digitalis
communis) to one or more fingers;
- Dutch resident (due to follow-up);
- Time from trauma to presentation at the hospital is less than 24 hours.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Amputation of an injured finger;
- Previous injury or operation in the damaged nerve, or brachial plexus damage;
- Crush injuries;
- Additional fractures at the injured site;
- Current substance abuse;
- Unable to finish follow-up for any reason.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to study the applicability of robotic-assisted<br /><br>microsurgery in DNR after trauma. The primary outcome is the quality of the<br /><br>anastomosis using Assessment of Microsurgery Skills (SAMS). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To provide important surgical and technical information, and to collect patient<br /><br>and surgeon satisfaction, the following secondary outcome measures are gathered:<br /><br>- Duration of surgery;<br /><br>- Adverse events, complications and robotic errors peri-operatively;<br /><br>- Post-operative complications and adverse events;<br /><br>- Surgeons satisfaction with the technique applied;<br /><br>- Patients satisfaction with the surgery procedure;<br /><br>- Recovery of sensation in the injured nerve;<br /><br>- Function of the hand over time. </p><br>