Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT04122157
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2019-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
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': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2019-10-08', 'studyFirstSubmitQcDate': '2019-10-08', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival, Kaplan Meier', 'timeFrame': 'up to 10 years after implantation', 'description': 'Survival rate: Rate of hip implants in situ after 10 years of follow-up.'}, {'measure': 'Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge', 'timeFrame': "up to patient's discharge from the hospital/clinic (from surgery up to 7 days after surgery)", 'description': 'Rate of hip implant experiencing intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge.\n\nRate of hip implants with Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects'}, {'measure': 'Postoperative AE up to 10 years after the surgery', 'timeFrame': 'up to 10 years after implantation', 'description': 'Rate of hip implants experiencing Postoperative AE up to 10 years after the surgery Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects'}], 'secondaryOutcomes': [{'measure': 'Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.', 'timeFrame': 'up to 10 years after implantation', 'description': 'Rate of hip implants with radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.'}, {'measure': 'Harris Hip Score', 'timeFrame': 'up to 10 years after implantation', 'description': 'The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty.The score considers information on pain, function and range of motion. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.'}, {'measure': 'WOMAC Osteoarthritis Index', 'timeFrame': 'up to 10 years after implantation', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:\n\nPain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on I off toilet, heavy domestic duties, light domestic duties. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uncoated SL PLUS® MIA stem'], 'conditions': ['Primary Total Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Summary from initial protocol\n\nGoal: Validation of the uncoated SL-PLUS® MIA stem within an observation study\n\nStudy design: prospective, single-center, observational, non-comparative study\n\nStudy population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)\n\nIntervention (if applicable): Implantation of a total hip endoprosthesis\n\nMain goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration; clinical: Harris Hip Score, implant-related complications, revisions; patient questionnaire (WOMAC)\n\nType and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '135 consecutive cases (uncoated SL-PLUS® MIA implants)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary or secondary hip osteoarthritis\n* Patients scheduled for a first implantation\n* Age at the time of surgery 40-80 years\n\nExclusion Criteria:\n\n* Destruction of the acetabulum\n* Deformation of the hip joint\n* Deformation of the proximal femur\n* Revision of failed hip endoprostheses\n* Acute or recent infection of the joint or its surrounding region\n* Acute or chronic systemic infections\n* Marked atrophy or deformation of the upper femur\n* Muscle atrophy or a neuromuscular disease\n* Pathological fractures\n* Per- to subtrochanteric fractures\n* Conditions that would prevent secure anchoring of the hip prosthesis\n* Obese patients with a BMI \\>35\n* Patients not expected to have a successful rehabilitation'}, 'identificationModule': {'nctId': 'NCT04122157', 'acronym': 'SL-PLUS MIA', 'briefTitle': 'Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem', 'orgStudyIdInfo': {'id': 'D10055-2'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Vinzenz v. Auersperg, Prim. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopädie LKH Steyr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew Orthopaedics AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}