Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT06903767
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-01
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated V Manual Impactor Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiological strain in the surgeon', 'timeFrame': '1 day', 'description': 'Through the use of a Hexoskin vest worn by the surgeon, we will measure heart rate, heart rate variability, respiratory rate, minute ventilation, and energy expenditure to determine overall physiological strain on the surgeon during total hip arthroplasty.'}], 'secondaryOutcomes': [{'measure': 'Patient Adverse Events', 'timeFrame': '6 weeks', 'description': 'Patient adverse events such as periprosthetic fractures intra- or postoperatively, intraoperative soft tissue injury, etc. will be recorded intra or postoperatively.'}, {'measure': 'F-NRS', 'timeFrame': '1 day', 'description': 'We will assess the Fatigue numeric rating scale (F-NRS) of surgeons after each case via survey.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Total Hip Arthroplasty (THA)', 'Impaction', 'Physiological Strain']}, 'descriptionModule': {'briefSummary': 'This study investigates the use of an automated impactor device in total hip arthroplasty versus manual malleting method and the physiological strain on the surgeon. This study will be a randomized, prospective, multicenter study involving fellowship-trained arthroplasty surgeons. Each participating surgeon will contribute data from 50 primary, elective THA cases, using the HAMMR powered impactor in 25 cases and manual impaction in 25 cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing primary elective THAs Participants over the age of 18 Patients with compatible implants\n\nExclusion Criteria:\n\nAttending orthopaedic surgeons with pre-existing cardiorespiratory or musculoskeletal conditions Use of cemented or hybrid THA Patients undergoing a conversion or revision THA Patients undergoing a non-elective THA (i.e., for fracture) Participants lacking cognitive capacity to consent Participants who are pregnant'}, 'identificationModule': {'nctId': 'NCT06903767', 'briefTitle': 'Automated V Manual Impactor Study', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Do Quantifiable Differences in Physiologic Stress Exist in Surgeons When Comparing the Use of a Powered Femoral Impactor Versus Manual Impaction in Total Hip Arthroplasty?', 'orgStudyIdInfo': {'id': 'JLON1384286'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Malleting Group', 'description': 'For cases that are randomized to the manual malleting group, surgeons will utilize a manual mallet to perform impaction during total hip arthroplasty while wearing the Hexoskin shirt.', 'interventionNames': ['Device: Manual Malleting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Automated Impaction HAMMR Group', 'description': 'For cases that are randomized to the automated impaction HAMMR group, surgeons will utilize an automated impaction device to perform impaction during total hip arthroplasty while wearing the Hexoskin shirt.', 'interventionNames': ['Device: Automated Impaction (HAMMR)']}], 'interventions': [{'name': 'Automated Impaction (HAMMR)', 'type': 'DEVICE', 'description': 'For cases that are randomized to the automated impaction HAMMR group, the surgeon will utilize an automated impactor device for impaction of the implant during total hip arthroplasty.', 'armGroupLabels': ['Automated Impaction HAMMR Group']}, {'name': 'Manual Malleting', 'type': 'DEVICE', 'description': 'For cases that are randomized to the manual malleting group, the surgeon will utilize a mallet for impaction of the implant during total hip arthroplasty.', 'armGroupLabels': ['Manual Malleting Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Camilo Restrepo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rothman Orthopaedic Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'collaborators': [{'name': 'UCLA Health - Santa Monica Medical Center', 'class': 'UNKNOWN'}, {'name': 'University of Virginia', 'class': 'OTHER'}, {'name': 'Orthopedic + Fracture Specialists, Portland, OR', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Trials', 'investigatorFullName': 'tnicholson', 'investigatorAffiliation': 'Rothman Institute Orthopaedics'}}}}