Werewolf Flow 50 During ACL Reconstruction

Children's Hospital Colorado

Status: Enrolling

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

Treatments: Device: Werewolf FLOW 50; Other: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04998656

20-2720

Details and patient eligibility

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).

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups, including a placebo group

Werewolf FLOW 50 Group

Active Comparator group

Description:

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

Treatment:

Device: Werewolf FLOW 50

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Control