Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-27 @ 2:21 PM
Study NCT ID:
NCT05461118
Status:
UNKNOWN
Last Update Posted:
2022-08-01
First Post:
2022-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteotomy Accuracy Using Mixed Reality Assisted Navigation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an interventional clinical trial, in which prospectively enrolled subjects will be compared with the historical control arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurements of osteotomy change on one-time post-operative imaging of CT scans', 'timeFrame': 'One time measurement completed within 1 month of surgery on postoperative CT scans of the face that are obtained within 3 weeks following surgery.', 'description': '3-dimensional depth mapping of postoperative CT scans overlaid on preoperative virtually planned osteotomy to assess for a change from the preoperative plan measured in millimeters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mixed Reality Navigation'], 'conditions': ['Osteotomy']}, 'descriptionModule': {'briefSummary': 'An osteotomy is a standard surgical operation in which one or more bones are cut or lengthened or re-shaped. While planning for osteotomy, the surgeon sometimes uses a custom-manufactured cutting guide. The investigators are testing a relatively new approach called mixed reality navigation in planning this surgery in this study.\n\nFor the purpose of this study, the investigators will compare the accuracy of performing osteotomies with the aid of mixed reality navigation as compared to osteotomies that were performed using prefabricated cutting guides for patients in the past few years.', 'detailedDescription': 'The use of virtual surgical planning and custom cutting guide fabrication for craniomaxillofacial osteotomies is becoming more and more common, but it remains very expensive at present, particularly for cranial procedures. As such, many practitioners utilize open-source third-party software and in-house 3D printing to aid in reducing operating costs while maintaining surgical precision and accuracy as well as the benefits of decreased intraoperative time. The use of augmented and mixed reality platforms in craniomaxillofacial surgery has demonstrated usefulness in both preoperative planning and intraoperative visualization. It has been used in the past several years during craniofacial resective procedures, orthognathic surgery, dental implantology, and surgical education.\n\nThe purpose of investigating the accuracy of preplanned craniomaxillofacial osteotomies using the aid of a mixed reality platform viewer to augment currently available navigation platforms is to demonstrate a non-inferiority of the osteotomy technique compared to the current clinical gold standard for both precision and accuracy of craniomaxillofacial osteotomies - the use of custom patient-specific cutting guides based on preoperative virtual surgical planning.\n\nThe primary objective of this prospective study is to evaluate the accuracy of craniomaxillofacial osteotomies performed with the aid of mixed reality navigation as compared to osteotomies performed using prefabricated cutting guides for similar procedures that have been planned virtually preoperatively.\n\nThe secondary objective is to determine if osteotomies performed using mixed reality navigation can be effectively completed in a minimally invasive manner.\n\nHypothesis: Craniomaxillofacial osteotomies performed via the mixed reality navigation method can be completed with the same degree of accuracy to a preoperative virtual surgical plan as with the use of custom printed cutting guides or within 2 mm of variance.\n\nSample size: n=16 patients/group to achieve a power of 0.8 and a significance level of 0.05. The investigators expect to recruit 40 patients total for the study site, including a 20% drop rate for each group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 16 years and older\n* Has a benign or malignant mandibular or maxillary pathology who will require resection and who will undergo immediate reconstruction\n* Consents to have resective and reconstructive procedures completed with the aid of mixed reality assisted navigation.\n\nExclusion Criteria:\n\n1. Presence of acute infection at the time of surgery\n2. Not able to speak in English or illiterate or lacking the decision-making capacity to consent for study.\n3. Pregnant women because elective surgery is usually delayed until after delivery to avoid risks and complications associated with anesthetics'}, 'identificationModule': {'nctId': 'NCT05461118', 'briefTitle': 'Osteotomy Accuracy Using Mixed Reality Assisted Navigation', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Osteotomy Accuracy Using Mixed Reality Assisted Navigation', 'orgStudyIdInfo': {'id': '[1829157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Consented subjects will undergo osteotomies for their resective and reconstructive procedures using mixed reality adjuncts (Magic Leap ®, Microsoft Hololens ®) to commercially available navigation platforms (BrainLAB ®).', 'interventionNames': ['Procedure: Experimental:Treatment group']}], 'interventions': [{'name': 'Experimental:Treatment group', 'type': 'PROCEDURE', 'description': 'Osteotomy surgical planning to be done using intraoperative mixed reality augmentation of a commercially available navigation platform.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marshall Newman, DMD', 'role': 'CONTACT', 'email': 'marnewman@augusta.edu', 'phone': '706-723-4511'}, {'name': 'Jaspreet Farmaha, PhD', 'role': 'CONTACT', 'email': 'jfarmaha@augusta.edu', 'phone': '7067211270'}], 'facility': 'Augusta University-Dental College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'centralContacts': [{'name': 'Marshall F Newman, DMD', 'role': 'CONTACT', 'email': 'marnewman@augusta.edu', 'phone': '706-723-4511'}, {'name': 'Jaspreet Farmaha, PhD', 'role': 'CONTACT', 'email': 'jfarmaha@augusta.edu', 'phone': '706-721-1270'}], 'overallOfficials': [{'name': 'Marshall F Newman, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dental College of Georgia- Augusta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study results will be published in a peer-reviewed journal upon completion and presented at appropriate conferences.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Marshall Newman', 'investigatorAffiliation': 'Augusta University'}}}}