Werewolf Flow 50 During ACL Reconstruction

Completed · Not applicable

Conditions studied: Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Arthrofibrosis of Knee

In brief

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).

Key facts

Study ID

NCT04998656

Run by

University of Colorado, Denver

People needed

182

Starts

2021-07-12

Expected to finish

2024-11-02

Last updated by the study team

2025-05-14

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 12-18 (inclusive) at time of surgery
• Scheduled to undergo ACL reconstruction performed at Children's Hospital Colorado or associated network of care site.

You may not qualify if…

• Underlying congenital or musculoskeletal disorders
• Pregnant females, prisoners, and wards of the state
• Persons deemed incompetent and those who have limited decision-making capacity

Where it is running

• 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

Full record on ClinicalTrials.gov

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