Clinical trial NCT04998656: Werewolf Flow 50 During ACL Reconstruction
Official title: Werewolf Flow 50 During ACL Reconstruction: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Tear
Arthrofibrosis of Knee
Keywords: ACL
Anterior Cruciate Ligament
Arthrofibrosis
Knee
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2021-08-10
Enrollment: 182
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of Post-Operative Arthrofibrosis
timeFrame: 1 year post-operative
Secondary outcomes:
measure: Range of Motion
timeFrame: 1 year post-operative
measure: Patient Reported Outcomes
timeFrame: 1 year post-operative
measure: Complications
timeFrame: 1 year post-operative
Other outcomes:
measure: Procedure Time
timeFrame: Through study completion, an average of 1 year
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado, Main Campus
state: Colorado
city: Broomfield
country: United States
facility: Children's Hospital Colorado, North Campus
state: Colorado
city: Highlands Ranch
country: United States
facility: Children's Hospital Colorado, South Campus
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Jay C Albright, MD
role: PRINCIPAL_INVESTIGATOR
References: