Werewolf Flow 50 During ACL Reconstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Werewolf Flow 50 During ACL Reconstruction: A Randomized Control Trial

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

Intervention / Treatment
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* Device: Werewolf FLOW 50
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, Anterior Cruciate Ligament, Arthrofibrosis, Knee