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Werewolf FLOW 50 During ACL Reconstruction

Sponsor
Children's Hospital Colorado (Other)
Overall Status
Recruiting
CT.gov ID
NCT04998656
Collaborator
Smith & Nephew, Inc. (Industry)
160
Enrollment
4
Locations
2
Arms
35.6
Anticipated Duration (Months)
40
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Werewolf FLOW 50
  • Other: Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants will not be told whether the Werewolf Flow 50 device was used during their surgery or not.
Primary Purpose:
Prevention
Official Title:
Werewolf FLOW 50 During ACL Reconstruction: A Randomized Control Trial
Actual Study Start Date :
Jul 12, 2021
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Werewolf FLOW 50 Group

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

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.
Placebo Comparator: Control Group

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

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.
Other Names:
  • No Electrocautery Device

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rates of Post-Operative Arthrofibrosis [1 year post-operative]

      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.

    Secondary Outcome Measures

    1. Range of Motion [1 year post-operative]

      Based on post-operative clincal examinations, we will compare the knee range of motion between the Werewolf FLOW 50 Group and the Control Group.

    2. Patient Reported Outcomes [1 year post-operative]

      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.

    3. Complications [1 year post-operative]

      We will compare rates of post-operative complications between the Werewolf FLOW 50 Group and the Control Group.

    Other Outcome Measures

    1. Procedure Time [Through study completion, an average of 1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Colorado, Aurora Colorado United States 80011
    2 Children's Hospital Colorado, Main Campus Aurora Colorado United States 80045
    3 Children's Hospital Colorado, North Campus Broomfield Colorado United States 80023
    4 Children's Hospital Colorado, South Campus Highlands Ranch Colorado United States 80129

    Sponsors and Collaborators

    • Children's Hospital Colorado
    • Smith & Nephew, Inc.

    Investigators

    • Principal Investigator: Jay C Albright, MD, Children's Hospital Colorado

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jay Albright, Orthopedic Surgeon, Children's Hospital Colorado
    ClinicalTrials.gov Identifier:
    NCT04998656
    Other Study ID Numbers:
    • 20-2720
    First Posted:
    Aug 10, 2021
    Last Update Posted:
    Aug 10, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Jay Albright, Orthopedic Surgeon, Children's Hospital Colorado
    ACL
    Anterior Cruciate Ligament
    Arthrofibrosis
    Knee
    Additional relevant MeSH terms:
    Rupture
    Anterior Cruciate Ligament Injuries

    Study Results

    No Results Posted as of Aug 10, 2021