Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Arthrofibrosis of Knee
Conditions
Keywords
ACL, Anterior Cruciate Ligament, Arthrofibrosis, Knee
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.
Interventions
DEVICEWerewolf 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.
OTHERControl
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.
Sponsors
University of Colorado, Denver
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will not be told whether the Werewolf Flow 50 device was used during their surgery or not.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Post-Operative Arthrofibrosis | 1 year post-operative | Number of participants with post-operative arthrofibrosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion - Knee | 1 year post-operative | Knee range of motion measured by knee extension and knee flexion, measured in degrees. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | 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. |
| Complications | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJay C Albright, MD
Children's Hospital Colorado
Participant flow
Pre-assignment details
This value includes 4 participants that consented and enrolled in the study, but then withdrew before randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 15.4 Years STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian Asian | 1 Participants |
| Race/Ethnicity, Customized Asian Black or African-American | 5 Participants |
| Race/Ethnicity, Customized Asian More than one race | 7 Participants |
| Race/Ethnicity, Customized Asian Other | 8 Participants |
| Race/Ethnicity, Customized Asian Unkown or not reported | 5 Participants |
| Race/Ethnicity, Customized Asian White | 71 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
None listed