Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04998656
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2021-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Werewolf Flow 50 During ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will not be told whether the Werewolf Flow 50 device was used during their surgery or not.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2021-06-01', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedure Time', 'timeFrame': 'Through study completion, an average of 1 year', 'description': "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."}], 'primaryOutcomes': [{'measure': 'Rates of Post-Operative Arthrofibrosis', 'timeFrame': '1 year post-operative', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Range of Motion', 'timeFrame': '1 year post-operative', 'description': 'Based on post-operative clinical examinations, we will compare the knee range of motion between the Werewolf FLOW 50 Group and the Control Group.'}, {'measure': 'Patient Reported Outcomes', 'timeFrame': '1 year post-operative', 'description': '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.'}, {'measure': 'Complications', 'timeFrame': '1 year post-operative', 'description': 'We will compare rates of post-operative complications between the Werewolf FLOW 50 Group and the Control Group.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ACL', 'Anterior Cruciate Ligament', 'Arthrofibrosis', 'Knee'], 'conditions': ['Anterior Cruciate Ligament Injuries', 'Anterior Cruciate Ligament Rupture', 'Anterior Cruciate Ligament Tear', 'Arthrofibrosis of Knee']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162074', 'label': '510(k) Premarket Notification for Werewolf FLOW 50 Device'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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).', 'detailedDescription': "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.\n\nThere 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.\n\nThere 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ages 12-18 (inclusive) at time of surgery\n* Scheduled to undergo ACL reconstruction performed at Children's Hospital Colorado or associated network of care site.\n\nExclusion Criteria:\n\n* Underlying congenital or musculoskeletal disorders\n* Pregnant females, prisoners, and wards of the state\n* Persons deemed incompetent and those who have limited decision-making capacity"}, 'identificationModule': {'nctId': 'NCT04998656', 'briefTitle': 'Werewolf Flow 50 During ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Werewolf Flow 50 During ACL Reconstruction: A Randomized Control Trial', 'orgStudyIdInfo': {'id': '20-2720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Werewolf FLOW 50 Group', 'description': 'The Werewolf FLOW 50 electrocautery device will be used during surgical treatment for patients assigned to this group.', 'interventionNames': ['Device: Werewolf FLOW 50']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'No electrocautery device will be used during surgical treatment for patients assigned to this group.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Werewolf FLOW 50', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Werewolf FLOW 50 Group']}, {'name': 'Control', 'type': 'OTHER', 'otherNames': ['No Electrocautery Device'], 'description': '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.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado, Main Campus", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80023', 'city': 'Broomfield', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado, North Campus", 'geoPoint': {'lat': 39.92054, 'lon': -105.08665}}, {'zip': '80129', 'city': 'Highlands Ranch', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado, South Campus", 'geoPoint': {'lat': 39.55388, 'lon': -104.96943}}], 'overallOfficials': [{'name': 'Jay C Albright, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Colorado"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with individuals outside of the authorized study team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}