Pilot Evaluation of the TissueStat-A Novel Device for Minimally Invasive Spine Surgery Fascial Closure
Jonathan Dalton1, Alexander Crawford, Rachel Huang
1Department of Orthopaedic Surgery, Rothman Orthopaedic Institute at Thomas Jefferson University Hospital, Philadelphia, PA.
Study Design:
Pilot Evaluation Study.
Objective:
To assess the ease-of-use and performance of TissueStat, a novel minimally invasive spine surgery (MIS) fascial closure device, compared with conventional suturing techniques.
Summary Of Background Data:
Wound issues in spine surgery can be a major source of morbidity and decreased patient satisfaction. A robust, multilayered closure can lead to decreased complications and need for revision surgery. However, the development of technology to assist in MIS fascial closures has lagged.
Methods:
Participants completed a fascial suturing trial using a benchtop model with both conventional suture and TissueStat. Time to completion and accuracy of each suture pass with were compared using the Student t test. After the trial, participants filled out a survey to quantify the ease of use and accuracy of conventional suture versus TissueStat. Survey responses were compared using descriptive statistics.
Results:
Eight participants were recruited (5 orthopaedic surgery residents and 3 orthopaedic spine surgery fellows). This group performed 16 attempts with the conventional suturing technique and 16 attempts with TissueStat. The average time to knot completion of the conventional suturing technique was slower than TissueStat [3 min and 22 s (range: 1:27-5:19) vs. 2 min and 1 s (range: 1:22-3:15), P=0.001]. The average distance from the suture location to the target dot was larger for the conventional suturing compared with TissueStat (1.25 vs. 0.22 mm, P=0.007). Participants reported a higher average ease of use score for TissueStat compared with conventional suture (9.4 vs. 3.9). Participants reported a higher average accuracy rating for TissueStat compared with the conventional suture (9.3 vs. 6.1). All participants answered that TissueStat offered the higher quality closure and allowed better suture targeting.
Conclusion:
TissueStat may be a useful tool to decrease operative time, improve closure accuracy/quality, and assist with meticulous fascial soft-tissue handling.
