Summary

This study is an initial analysis to learn more about electrocautery devices used in Anterior Cruciate Ligament surgeries.

Abstract

Introduction

The literature regarding the efficiency, cost effectiveness, safety, and outcomes of
adolescent patients who have an anterior cruciate ligament reconstruction (ACLR) with the use
of electrocautery devices remains sparse. Good post-operative outcomes are widely achieved
with ACL reconstruction in young patients, but the reported incidence of arthrofibrosis following
ACL reconstruction has been as high as 26%.

Purpose

Our purpose was to conduct an initial (pre-planned interim/blinded) analysis
examining the safety profile and physical activity level of adolescents who were randomized to
an electrocautery device (Werewolf FLOW50) or institutional standard of care during ACLR.
We hypothesized that the safety profiles will be relatively similar, but that physical activity
scores at 6-months post-surgery would differ based on the presence of scar tissue.

Methods

We conducted a prospective randomized clinical trial comparing two surgical
techniques (electrocautery vs. standard-of-care) for surgeries performed between August 3, 2021
to December 7, 2021. ACLR was completed by one surgeon at one pediatric sports medicine
institution. Participants completed an initial pre-operative evaluation, underwent surgery, and
returned for follow-up approximately 6-months post-ACLR. This analysis represents an interim
(planned) analysis that maintains the blinding of group randomization to each approach,
therefore, groups are labelled as Approach A and Approach B. We compared demographic and
surgical characteristics between groups to ensure that randomization is effective. We then
examined complications that occurred between surgery and 6-months post-ACLR and compared
physical activity level at ?6-months post-ACLR using the Hospital for Special Surgery Pediatric
Functional Activity Brief Scale (HSS-Pedi FABS).

Results

We enrolled, randomized, and followed-up with 45 participants at least 6 months postACLR. There were no statistically significant demographic or surgical characteristic differences
between the two groups with regards to age, sex, insurance status, pre- and post-operative pain
and range of motion, pre-operative effusion, graft length, or concomitant cartilage procedure.
The time from surgery to follow-up (days) was not significantly different between groups
(169±39 vs 175±36 days; p=0.68). One complication was documented in each group: infection
of ACL graft (Approach A participant) and secondary knee manipulation under anesthesia due to
lack of mobility (Approach B participant). There was no significant between-group difference in
physical activity level based on HSS-Pedi FABS scores at 6-months post-ACLR.

Conclusion

Both electrocautery and standard-of-care approaches demonstrate a similar safety
profile at 6-months post-ACLR. Future work included evaluating the radiological presence of
arthrofibrosis between approaches at 6-months post-ACLR.