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COMPLETED
NCT04998656
NA

Werewolf Flow 50 During ACL Reconstruction

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

OTHER

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