Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT06033651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2023-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10) Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The survivourship of the modular acetabular hip system at 10 years post-op', 'timeFrame': 'Participants will be invited to attend a one time clinic visit, after which their participation in the study has ended.', 'description': 'This study will be the largest study to look at the survivorship of this acetabular system. Survivorship will be to the point of revision and clinical outcome survivorship is to the point of radiological loosening and PROMs data collection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Surgery']}, 'referencesModule': {'references': [{'pmid': '36516281', 'type': 'BACKGROUND', 'citation': 'Ben-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, Deere K, Esler C, Espinoza O, Evans J, Goldberg A, Gregson C, Howard P, Jameson S, Jennison T, Judge A, Lawrence S, Lenguerrand E, Marques E, McCormack V, Newell C, Pegg D, Penfold C, Porter M, Price A, Reed M, Rees J, Royall M, Sayers A, Stonadge J, Swanson M, Taylor D, Toms A, Watts A, Whitehouse M, Wilkinson M, Wilton T, Young E. The National Joint Registry 19th Annual Report 2022 [Internet]. London: National Joint Registry; 2022 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK587525/'}, {'pmid': '9865472', 'type': 'BACKGROUND', 'citation': 'Liu TK, Liu SH, Chang CH, Yang RS. Concentration of metal elements in the blood and urine in the patients with cementless total knee arthroplasty. Tohoku J Exp Med. 1998 Aug;185(4):253-62. doi: 10.1620/tjem.185.253.'}]}, 'descriptionModule': {'briefSummary': 'Patients are to be approached to attend clinic who have been identified as being implanted with either a Lima Corporate Delta Revision TT, Delta One TT or the Delta Multihole Systems hip systems between 2011 and 2015, a minimum of 10 years since hip surgery. They will be x-rayed (AP pelvis and a lateral view) and have a clinical review in clinic.', 'detailedDescription': "Since its popularisation in the 1960's, Hip replacements have become one of the NHS's highest volume procedures. Unfortunately, hip replacements can fail with on average 8,500 revision hip replacements being performed each year pre-covid(1). Often this is very complex with destruction of the normal anatomy leaving surgeons with a significant challenge in ensuring appropriate positioning of the socket within the confines of the patient's anatomy.\n\nThe Lima Corporate Delta systems are designed to help surgeons with this very problem by providing the option of a 'face changer' allowing surgeons to place a socket within a socket.\n\nTo allow for this function, the 'face changer' must connect with the acetabular cup (socket).\n\n140 patients have been identified as having had this modular acetabular system implanted at the RJAH in 2012 \\& 2014, going into 2015. The aim of this study is to therefore identify the survivorship of these implants at 10 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.\n\nExclusion Criteria:\n\nDeceased patients Patients who have undergone a subsequent acetabular revision Patients that lack capacity Prisoners in the custody of HM Prison service or who are offenders supervised by the probation service in England or Wales.'}, 'identificationModule': {'nctId': 'NCT06033651', 'acronym': 'TinT10', 'briefTitle': 'Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10) Levels', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust'}, 'officialTitle': 'Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10)', 'orgStudyIdInfo': {'id': 'RL1 879'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Only 1 arm for the study', 'description': 'All participants shall receive the same treatment.', 'interventionNames': ['Radiation: x-ray']}], 'interventions': [{'name': 'x-ray', 'type': 'RADIATION', 'otherNames': ['AP view of pelvis'], 'description': 'AP view of pelvis', 'armGroupLabels': ['Only 1 arm for the study']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julie Steen', 'role': 'CONTACT', 'email': 'julie.steen@nhs.net', 'phone': '+441691404418', 'phoneExt': '4418'}, {'name': 'Thomas Banks', 'role': 'CONTACT', 'email': 'thomas.banks3@nhs.net', 'phone': '+441691404418'}], 'overallOfficials': [{'name': 'Robin Banerjee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}