Werewolf Flow 50 During ACL Reconstruction
Sponsored by Children's Hospital Colorado
About this trial
Last updated 2 years ago
Study ID
20-2720
Status
Recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
12 to 18 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended a year ago
What is this trial about?
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).
What are the participation requirements?
Inclusion Criteria
- 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.
Exclusion Criteria
- Underlying congenital or musculoskeletal disorders
- Pregnant females, prisoners, and wards of the state
- Persons deemed incompetent and those who have limited decision-making capacity
Locations
Location
Status
Recruiting
Recruiting
Recruiting
Recruiting