Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-03 @ 10:49 AM
Study NCT ID:
NCT02808169
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2016-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radlink GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2016-06-17', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of intra-op values for acetabular inclination and ante version, limb length using Radlink with those obtained and 4-8 weeks postop digital films.', 'timeFrame': '4-8 weeks'}], 'secondaryOutcomes': [{'measure': 'Accuracy of cup placement/limb length with Radlink to a predetermined value and what surgeon obtains with Radlink guidance.', 'timeFrame': '4-8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Implant Position in Total Hip Replacement']}, 'descriptionModule': {'briefSummary': 'Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.', 'detailedDescription': 'Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.\n\nGPS may improve total hip replacement by allowing surgeons to measure the exact position of components placed during surgery and there is a question whether RADLINK helps surgeons place the acetabular cup (the part that goes into the hip bone) component in a precise position. The objective of the study is to determine whether GPS gives surgeons reliable, valid information about the orientation of the cup component. The surgeons need to collect data to help clarify this issue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient under going total hip replacement', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both: both female and male participants are being studied.\n* Minimum Age: Age of participants is between 20 years - 75 years.\n* Accepts: Persons who are in need of a total hip replacement\n\nExclusion Critieria:\n\n* Has an existing condition that would compromise participation\n* Had previous surgery on affected hip'}, 'identificationModule': {'nctId': 'NCT02808169', 'briefTitle': 'Radlink GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion', 'organization': {'class': 'INDIV', 'fullName': 'Barrett, William, M.D.'}, 'officialTitle': 'Radlinik GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion', 'orgStudyIdInfo': {'id': '20151031'}}, 'contactsLocationsModule': {'locations': [{'zip': '98055', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'VOA Research Foundation', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'William Barrett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VOA Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barrett, William, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'DePuy Synthes', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'William P. Barrett, MD', 'investigatorFullName': 'William Barrett, M.D.', 'investigatorAffiliation': 'Barrett, William, M.D.'}}}}