Werewolf Flow 50 During ACL Reconstruction

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Rupture; Arthrofibrosis of Knee; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Injuries
• Interventions: Device: Werewolf FLOW 50; Other: Control

• Registration Number: NCT04998656
• Lead Sponsor: University of Colorado, Denver

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).

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 Timeline

• Study First Submitted: 2021-06-01
• Study Start: 2021-07-12
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-10
• Primary Completion: 2024-11-02
• Study Completion: 2024-11-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Werewolf FLOW 50 Group	Werewolf FLOW 50	The Werewolf FLOW 50 electrocautery device will be used during surgical treatment for patients assigned to this group.
Control Group	Control	No electrocautery device will be used during surgical treatment for patients assigned to this group.

Primary Outcome Measures

Name	Time	Method
Rates of Post-Operative Arthrofibrosis	1 year post-operative	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.

Secondary Outcome Measures

Name	Time	Method
Range of Motion	1 year post-operative	Based on post-operative clinical examinations, we will compare the knee range of motion between the Werewolf FLOW 50 Group and the Control Group.
Patient Reported Outcomes	1 year post-operative	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.
Complications	1 year post-operative	We will compare rates of post-operative complications between the Werewolf FLOW 50 Group and the Control Group.

Trial Locations

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