The aim of this study is to compare the outcomes, ease of use, and cost of the Werewolf FLOW50 device to our institutional standard of care which is does not include the use of electrocautery devices during anterior cruciate ligament reconstruction (ACLR) surgery in patients 12-18 years of age using a randomized control trial design.
Participation in this study will not affect the pre, post, or intra-operative care of ACL reconstruction in any way other than either the use of the use of the Werewolf FLOW 50 device or not and the performance of MRI at 6 months postoperative. All involvement and participation will be completely voluntary. The MRI taking place at 6 months post-operative is the only study data point that is additional to our institutional standard of care for treatment of ACL injuries.
Inclusion Criteria i. Ages 12-18 (inclusive) at time of surgery ii. Scheduled to undergo ACL reconstruction performed at Children’s Hospital Colorado or associated network of care site. Exclusion Criteria i. Underlying congenital or musculoskeletal disorders ii. Pregnant females, prisoners, and wards of the state iii. Persons deemed incompetent and those who have limited decision-making capacity
Principal Investigator