This study will assess the applicability of robotic-assisted microsurgery in DNR after trauma.
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to study the applicability of robotic-assisted
microsurgery in DNR after trauma. The primary outcome is the quality of the
anastomosis using Assessment of Microsurgery Skills (SAMS).
Secondary outcome
To provide important surgical and technical information, and to collect patient
and surgeon satisfaction, the following secondary outcome measures are gathered:
- 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;
- Recovery of sensation in the injured nerve;
- Function of the hand over time.
Background summary
During microsurgical performances, the surgeon*s hands always have a small
physiological tremor, which limits precision. Hence, to improve movement
precision, robotic-assisted microsurgery might be of great importance.
Currently we are performing robotic-assisted microsurgery in lymphatico-venular
anastomosis (LVA), with the next step being expanding the use of the
robotic-assisted microsurgery to digital nerve repairs (DNR).
Study objective
This study will assess the applicability of robotic-assisted microsurgery in
DNR after trauma.
Study design
In a prospective feasibility study ten patients with traumatic digital nerve
injury will undergo robotic-assisted repair of the damaged nerve(s). The
primary outcome is the quality of anastomoses using Structured Assessment of
Microsurgery Skills (SAMS). Secondary outcome measures include long term
sensibility, duration of the surgery, adverse events, complications
peri-operatively, the surgeon*s satisfaction and the function of the injured
hand.
Intervention
Using the Microsure robot the nerve is repaired with ethilon 9.0 or 10.0
sutures after debridement of the wound and the nerve ends.
The amount of sutures and indication for primary repair of the nerve laceration
is decided by the operating microsurgeon. Additional vascular or tendon injury
will be repaired in the same operation.
Study burden and risks
A similar study in robotic- assisted nerve repair has not yet been performed
with this first robotic platform for microsurgery. However, the robot has been
extensively tested in preclinical trials. Currently the robot is used for
robotic-assisted LVA in a pilot study. Participating surgeons will be
sufficiently trained to use the robot.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64178.068.17 |
| Other | NTRnr volgt |