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Werewolf Flow 50 During ACL Reconstruction
Sponsor: University of Colorado, Denver
Summary
The aim of this study is to compare the outcomes, ease of use, and cost of the Werewolf FLOW50 device to the 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. The investigators hypothesize that a lower proportion of participants who undergo ACLR and are randomized to the Werewolf FLOW50 procedure will experience post-operative arthrofibrosis compared to those randomized to standard of care (control group).
Official title: Werewolf Flow 50 During ACL Reconstruction: A Randomized Control Trial
Key Details
Gender
All
Age Range
12 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2021-07-12
Completion Date
2024-11-02
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Werewolf FLOW 50
Use of Werewolf FLOW 50 electrocautery device during surgical treatment for ACL injury. This device is often used as standard of care when our other standard of care approach (use of no electrocautery device) is not used.
Control
Use of no electrocautery device during surgical treatment for ACL injury. This approach is often used as standard of care when our other standard of care approach (use of Werewolf FLOW 50 electrocautery device) is not used.
Locations (3)
Children's Hospital Colorado, Main Campus
Aurora, Colorado, United States
Children's Hospital Colorado, North Campus
Broomfield, Colorado, United States
Children's Hospital Colorado, South Campus
Highlands Ranch, Colorado, United States