Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2026-01-17 @ 12:21 PM
Study NCT ID:
NCT03120312
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2017-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Term and Long Term Outcome for Elderly Patients Treated With Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2017-04-15', 'studyFirstSubmitQcDate': '2017-04-15', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life during 5 years after surgery', 'timeFrame': '5 years', 'description': 'evaluate the quality of life after surgery by WHO QOL-BREF scale with interview ，WHO QOL-BREF scale includes five aspects: physical, psychological, social, environmental, integrated, divided into five levels'}], 'secondaryOutcomes': [{'measure': 'The incidence of postoperative complications', 'timeFrame': 'from 7 days to 1 year', 'description': 'Participants will be followed for the incidence of postoperative complications'}, {'measure': 'Mortality during 5 years after surgery', 'timeFrame': 'during 5 years', 'description': 'Participants will be followed for Survival rate during 5 years after surgery'}]}, 'conditionsModule': {'keywords': ['outcome'], 'conditions': ['Total Hip Replacement']}, 'referencesModule': {'references': [{'pmid': '18772476', 'type': 'BACKGROUND', 'citation': 'Penrod JD, Litke A, Hawkes WG, Magaziner J, Doucette JT, Koval KJ, Silberzweig SB, Egol KA, Siu AL. The association of race, gender, and comorbidity with mortality and function after hip fracture. J Gerontol A Biol Sci Med Sci. 2008 Aug;63(8):867-72. doi: 10.1093/gerona/63.8.867.'}, {'pmid': '17054955', 'type': 'BACKGROUND', 'citation': 'Foss NB, Palm H, Krasheninnikoff M, Kehlet H, Gebuhr P. Impact of surgical complications on length of stay after hip fracture surgery. Injury. 2007 Jul;38(7):780-4. doi: 10.1016/j.injury.2006.08.028. Epub 2006 Oct 19.'}, {'pmid': '22021865', 'type': 'BACKGROUND', 'citation': 'Singh JA, Jensen MR, Harmsen WS, Gabriel SE, Lewallen DG. Cardiac and thromboembolic complications and mortality in patients undergoing total hip and total knee arthroplasty. Ann Rheum Dis. 2011 Dec;70(12):2082-8. doi: 10.1136/ard.2010.148726. Epub 2011 Oct 21.'}, {'pmid': '23212287', 'type': 'BACKGROUND', 'citation': 'Krecisz B, Kiec-Swierczynska M, Chomiczewska-Skora D. Allergy to orthopedic metal implants - a prospective study. Int J Occup Med Environ Health. 2012 Sep;25(4):463-9. doi: 10.2478/S13382-012-0029-3. Epub 2012 Dec 3.'}, {'pmid': '908716', 'type': 'BACKGROUND', 'citation': 'Deutman R, Mulder TJ, Brian R, Nater JP. Metal sensitivity before and after total hip arthroplasty. J Bone Joint Surg Am. 1977 Oct;59(7):862-5.'}]}, 'descriptionModule': {'briefSummary': 'The is a retrospective analysis to study the characteristics of elderly patients treated with total hip replacements during past 5 years．', 'detailedDescription': 'Patients underwent total hip replacement due to removal of the hip caused by retrogressive lesions, is conducive to the improvement of hip function .But at the same time,the complications from patients accepted total hip replacement surgery will directly or indirectly affect the prognosis of the patients, resulting in patients with delayed recovery and increase the hospitalization time and cost. Serious complications can lead to patients deaths during perioperative period. This study was designed to provide a retrospective analysis of postoperative recovery, quality of life, and complications in patients undergoing hip replacement over the past five years, providing data for clinical studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From January 2012 to July 30，2017，approximately 1500 cases of primary hip replacement in this study，including male ，female and bilateral replacements．', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA Ⅱ-Ⅲ,elective operation patients，\n2. NO other severe complication history\n\nExclusion Criteria:\n\n1. Having severe comorbidity\n2. not for the first time of joint replacement\n3. Suffered from neurologic disorder or impaired mental state'}, 'identificationModule': {'nctId': 'NCT03120312', 'acronym': 'THR', 'briefTitle': 'Short Term and Long Term Outcome for Elderly Patients Treated With Total Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Shanxi Medical University'}, 'officialTitle': 'Short Term and Long Term Outcome for Elderly Patients Treated With Total Hip Replacements During Past 5 Years :A Retrospective Analysis', 'orgStudyIdInfo': {'id': 'ZGuo'}}, 'armsInterventionsModule': {'interventions': [{'name': 'total hip replacement', 'type': 'PROCEDURE', 'description': 'primary hip replacement patients during past 5 years．'}]}, 'contactsLocationsModule': {'locations': [{'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng Guo, MB，PhD', 'role': 'CONTACT', 'email': 'guozheng713@yahoo.com', 'phone': '+863513365790'}, {'name': 'Weijun Liang, MSc', 'role': 'CONTACT', 'email': 'weijun_liang@126.com', 'phone': '+863513365790'}, {'name': 'Zheng Guo, MB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zheng Guo', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Zheng Guo', 'role': 'CONTACT', 'email': 'guozheng713@yahoo.com', 'phone': '89351-3365790'}, {'name': 'Lili Wang', 'role': 'CONTACT', 'email': '15834058006@163.com', 'phone': '15834058006'}], 'overallOfficials': [{'name': 'Zheng Guo', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Hospital of Shanxi Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Hospital of Shanxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zheng Guo', 'investigatorAffiliation': 'Second Hospital of Shanxi Medical University'}}}}