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Electrosurgical Device

Werewolf FLOW 50 Device for ACL Reconstruction

N/A

Recruiting

Led By Jay C Albright, MD

Research Sponsored by Children's Hospital Colorado

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo ACL reconstruction performed at Children's Hospital Colorado or associated network of care site.

Ages 12-18 (inclusive) at time of surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-operative

Awards & highlights

Study Summary

This trial will compare the outcomes of two different procedures for ACL surgery in patients aged 12-18. One procedure uses a device called the Werewolf FLOW50, while the other (the control group) does not use electrocautery devices. The investigators hypothesize that the Werewolf FLOW50 procedure will result in a lower proportion of post-operative arthrofibrosis cases compared to the control group.

Who is the study for?

This trial is for young individuals aged 12-18 who are scheduled for ACL reconstruction surgery at Children's Hospital Colorado or its network sites. It excludes those with decision-making incapacity, pregnant females, prisoners, wards of the state, and anyone with congenital or musculoskeletal disorders.Check my eligibility

What is being tested?

The study compares a device called Werewolf FLOW50 to standard care without electrocautery in ACL reconstruction surgery. The goal is to see if the device reduces post-operative arthrofibrosis (joint stiffness) using a randomized control trial method.See study design

What are the potential side effects?

While specific side effects aren't listed for Werewolf FLOW50, potential risks may include typical surgical complications such as infection, bleeding, or increased recovery time compared to standard procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for ACL surgery at Children's Hospital Colorado or its network.

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I am between 12 and 18 years old and need surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rates of Post-Operative Arthrofibrosis

Secondary outcome measures

Complications

Patient Reported Outcomes

Range of Motion

Other outcome measures

Procedure Time

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Werewolf FLOW 50 GroupActive Control1 Intervention

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

Group II: Control GroupPlacebo Group1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Smith & Nephew, Inc.Industry Sponsor

165 Previous Clinical Trials

22,321 Total Patients Enrolled

Children's Hospital ColoradoLead Sponsor

116 Previous Clinical Trials

5,132,455 Total Patients Enrolled

Jay C Albright, MDPrincipal InvestigatorChildren's Hospital Colorado

Media Library

Werewolf FLOW 50 (Electrosurgical Device) Clinical Trial Eligibility Overview. Trial Name: NCT04998656 — N/A

Anterior Cruciate Ligament Injury Research Study Groups: Control Group, Werewolf FLOW 50 Group

Anterior Cruciate Ligament Injury Clinical Trial 2023: Werewolf FLOW 50 Highlights & Side Effects. Trial Name: NCT04998656 — N/A

Werewolf FLOW 50 (Electrosurgical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04998656 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for volunteers in this experiment?

"That is correct. The listing on clinicaltrials.gov reveals that the trial, which was established on July 12th 2021, is still open for enrollment. There are 4 sites recruiting a total of 160 patients."

Answered by AI

Are patients of legal age being evaluated for this research project?

"This trial is for patients aged 12-18. Out of the 133 similar trials, 60 are for a younger age group and 73 are for seniors."

Answered by AI

How many enrollees does this clinical trial have?

"The information available on clinicaltrials.gov supports that this trial is still looking for patients to enroll. The posting date was July 12th, 2021 and the most recent update occurred on August 3rd, 2021. In total, they need 160 people at 4 different locations."

Answered by AI

Could I potentially qualify to participate in this research study?

"This particular clinical trial is testing a new medical intervention for those that have an anterior cruciate ligament tear. To take part in the study, patients must be between 12 and 18 years old-- 160 participants are needed in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Werewolf Flow 50 During ACL Reconstruction

Jay Albright 2021. "Werewolf Flow 50 During ACL Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04998656.