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Completed

NCT Number: NCT04998656

Werewolf Flow 50 During ACL Reconstruction

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).

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Key information

Conditions

Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear Arthrofibrosis of Knee Knee Injuries Leg Injuries Wounds and Injuries

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado, Main Campus, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Werewolf FLOW 50

Device

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.

Control

Other

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.

Other names: No Electrocautery Device

Primary outcomes

  1. Rates of Post-Operative Arthrofibrosis

    Time frame: 1 year post-operative

    Number of participants with post-operative arthrofibrosis

Secondary outcomes

  1. Range of Motion - Knee

    Time frame: 1 year post-operative

    Knee range of motion measured by knee extension and knee flexion, measured in degrees.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Data reported below were collected approximately 6-months post-operatively.

    Based on patient reported outcomes (patient surveys) completed pre-operatively and post-operatively, we will compare levels of pain, functionality, and quality of life between the Werewolf FLOW 50 Group and the Control Group.

    PROMIS questionnaires are represented as t-scores, where a mean score of 50 with a standard deviation of 10 represents the general population.

    PROMIS Pediatric Short Form v2.0 - Mobility measures an individual's self-perceived mobility capabilities, such as getting up from a chair or running. Higher numbers indicate better outcomes.

    PROMIS Pediatric Short Form v2.0 - Pain Interference measures how much pain affects daily physical, mental and social activities. Higher numbers indicate worse outcomes.

    PROMIS Quality of Life in Neurological Disorders Short Form v1.0 - Lower Extremity Function measures walking, leg mobility and physical tasks for individuals with neurological conditions. Higher numbers indicate better outcomes.

  3. Complications

    Time frame: 1 year post-operative

    Number of participants with post-operative complications (including arthrofibrosis and injury) between the Werewolf FLOW 50 Group and the Control Group.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Official study title

Werewolf Flow 50 During ACL Reconstruction: A Randomized Control Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2021
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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