Werewolf Flow 50 During ACL Reconstruction

Werewolf Flow 50 During ACL Reconstruction: A Randomized Control Trial

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).

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Arthrofibrosis of Knee
• Intervention / Treatment: Device: Werewolf FLOW 50; Other: Control

Detailed Description

The investigators foresee minimal risks to participants. The Werewolf FLOW50 is an FDA approved medical device to be used in the knee joint. he surgeon performing each surgery has used both the Werewolf FLOW50 device (according to FDA-approved indications for use) and no electrocautery device as standard of care during ACL reconstruction surgery.

There is minimal risk associated with the subsequent MRI. Participants may experience slight discomfort from the confined space, flashing lights in their eyes, or temporary warmth/reddening of the skin following MRI. Participants will be informed of these risks and discomforts and pregnant participants or those with any metal and/or electronic devices inside their bodies will not receive the MRI.

There is the risk of unintended disclosure of protected health information (PHI) to individuals outside the research team. To mitigate this risk, data points are entered into a password-protected, HIPAA compliant REDCap database accessible to only the PIs and study personnel. Children's Colorado affiliated and approved study personal will have access to all study information collected at all involved study sites. However, other study sites will only have access to the information collected on patients enrolled at their site. We believe this system will contribute to the protection of PHI. The only PHI collected will be visit dates; all participants will be linked to their information via a unique study identifier.

The PI will periodically review the status of this protocol. Any unanticipated problems will be disclosed to COMIRB [Colorado Multiple Institutional Review Board] within five days with a cover letter detailing the assessment and actions to be taken.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado, Main Campus
    • Broomfield, Colorado, United States, 80023
      • Children's Hospital Colorado, North Campus
    • Highlands Ranch, Colorado, United States, 80129
      • Children's Hospital Colorado, South Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Werewolf FLOW 50 Group; The Werewolf FLOW 50 electrocautery device will be used during surgical treatment for patients assigned to this group.	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.
Placebo Comparator: Control Group; No electrocautery device will be used during surgical treatment for patients assigned to this group.	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.; Other Names: No Electrocautery Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes	Based on patient reported outcomes (patient surveys) completed pre-operatively and post-operatively, we will compare levels of pain, functionality, overall healing, and quality of life between the Werewolf FLOW 50 Group and the Control Group.	1 year post-operative
Complications	We will compare rates of post-operative complications between the Werewolf FLOW 50 Group and the Control Group.	1 year post-operative
Range of Motion	Based on post-operative clinical examinations, we will compare the knee range of motion between the Werewolf FLOW 50 Group and the Control Group.	1 year post-operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	After reviewing the operative note in each participant's medical record, we will compare the length of ACL reconstruction procedures between the Werewolf FLOW 50 Group and the Control Group.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Jay C Albright, MD, Children's Hospital Colorado

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): November 2, 2024
• Study Completion (Actual): November 2, 2024

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ACL; Anterior Cruciate Ligament; Knee; Arthrofibrosis
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Rupture
• Other Study ID Numbers: 20-2720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with individuals outside of the authorized study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No