Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
182 participants
INTERVENTIONAL
2021-07-12
2024-11-02
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Werewolf FLOW 50 Group
The Werewolf FLOW 50 electrocautery device will be used during surgical treatment for patients assigned to this group.
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.
Control Group
No electrocautery device will be used during surgical treatment for patients assigned to this group.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo ACL reconstruction performed at Children's Hospital Colorado or associated network of care site.
Exclusion Criteria
* Pregnant females, prisoners, and wards of the state
* Persons deemed incompetent and those who have limited decision-making capacity
12 Years
18 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Jay C Albright, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Locations
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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, United States
Countries
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Related Links
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510(k) Premarket Notification for Werewolf FLOW 50 Device
Other Identifiers
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20-2720
Identifier Type: -
Identifier Source: org_study_id
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