Werewolf Flow 50 During ACL Reconstruction

NCT04998656 | Completed FDA Device

• 1 other identifier: 20-2720
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Arthrofibrosis of Knee

Keywords

ACL; Anterior Cruciate Ligament; Arthrofibrosis; Knee

Outcome Measures

Primary Outcomes (1)

• Rates of Post-Operative Arthrofibrosis

  Based on post-operative MRIs of the knee, we will compare the rates of post-operative arthrofibrosis between the Werewolf FLOW 50 Group and the Control Group.

  1 year post-operative

Secondary Outcomes (3)

• Range of Motion

  1 year post-operative

• Patient Reported Outcomes

  1 year post-operative

• Complications

  1 year post-operative

Other Outcomes (1)

• Procedure Time

  Through study completion, an average of 1 year

Study Arms (2)

Werewolf FLOW 50 Group

ACTIVE COMPARATOR

The Werewolf FLOW 50 electrocautery device will be used during surgical treatment for patients assigned to this group.

Device: Werewolf FLOW 50

Control Group

PLACEBO COMPARATOR

No electrocautery device will be used during surgical treatment for patients assigned to this group.

Other: Control

Interventions

Werewolf FLOW 50 DEVICE

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.

Werewolf FLOW 50 Group

Control OTHER

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.

Also known as: No Electrocautery Device

Control Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (3)

Children's Hospital Colorado, Main Campus

Aurora, Colorado, 80045, United States

Location

Children's Hospital Colorado, North Campus

Broomfield, Colorado, 80023, United States

Location

Children's Hospital Colorado, South Campus

Highlands Ranch, Colorado, 80129, United States

Location

Related Links

• 510(k) Premarket Notification for Werewolf FLOW 50 Device

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Jay C Albright, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told whether the Werewolf Flow 50 device was used during their surgery or not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: August 10, 2021
• Study Start: July 12, 2021
• Primary Completion: November 2, 2024
• Study Completion: November 2, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)