Werewolf Flow 50 During ACL Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Werewolf Flow 50 During ACL Reconstruction: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04998656
• Other study ID #: 20-2720
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Children's Hospital Colorado
• Contact: Hannah C Rossing
• Phone: 720-434-2244
• Email: hannah.rossing[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Rupture

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado,	Aurora	Colorado
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Colorado	Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Complications	We will compare rates of post-operative complications between the Werewolf FLOW 50 Group and the Control Group.	1 year post-operative

External Links

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