Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-23 @ 2:51 PM
Study NCT ID:
NCT02471703
Status:
TERMINATED
Last Update Posted:
2021-02-21
First Post:
2015-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, '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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the SMF S\\&E study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2015-06-11', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revision of the study device', 'timeFrame': 'Discharge through 10 years', 'description': 'Instances of required revision of the study device'}, {'measure': 'Device related Adverse Events', 'timeFrame': 'Implant through 10 years', 'description': 'surgical, device-related, death and serious adverse events will be analyzed'}, {'measure': 'Harris Hip Score', 'timeFrame': 'Baseline through 10 years', 'description': 'Questionnaire to calculate pain, walking abilities, activities, degrees of hip motion'}, {'measure': 'HOOS Questionnaire', 'timeFrame': 'Baseline through 10 years', 'description': 'Questionnaire to calculate hip symptoms, stiffness, pain, function and quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Hip Arthroplasty', 'Total Hip Replacement', 'Inflammatory Joint Disease', 'Non-Inflammatory Joint Disease'], 'conditions': ['Joint Diseases']}, 'descriptionModule': {'briefSummary': 'This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.', 'detailedDescription': 'The objectives of this study are to evaluate the safety and efficacy of the study device. This study will document any device-related, surgical or post-operative complication and adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems. Outcome measures will be quantified through statistical analysis of study device , HOOS questionnaire, radiographic assessments, Harris Hip Score, and adverse event reports.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring total hip replacement.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient presents with non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis of or any of it's composite diagnosis.\n* Patient is of legal age to consent, is skeletally mature and at least 18 years old.\n* Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.\n* Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.\n\nExclusion Criteria:\n\n* Patient has poor bone stock and would make the procedure unjustifiable: A) patients which are under medical care for osteoporosis (taking hormones, Calcitonin or biphosphates) or for other metabolic pathologies, which could influence the quality of the bone (for example hyperparathyroidism, hyperthyreoidismus and osteomalacie) will be excluded from the study. B) patients suffering from Morbus Paget (osteodystrophia deformans) will be excluded from the study.\n* Patient has conditions that tend to place increased loads on implants such as weight, chargot joint, muscular deficiencies and activity level, which are incompatible with a satisfactory long-term result: A) patients with a BMI \\> 40 will be excluded from the study B) patients participating in high-impact sports like baseball, basketball, football, handball, hockey, karate, racquet-ball, running, soccer, water skiing or similar impact sports will be excluded from the study.\n* Patient is over the age of 75.\n* Skeletal immaturity: patients must be at least 18 years at the time of the operation.\n* Patient has an active, local infection that would lead to increased bone resorption.\n* Mental or neurological conditions that tend to pre-empt the patient's ability or willingness to restrict activities.\n* Known sensitivity to materials of the implant.\n* Patient is pregnant or plans to be come pregnant during the course of the study.\n* Patient is a prisoner."}, 'identificationModule': {'nctId': 'NCT02471703', 'acronym': 'SMF-S&E', 'briefTitle': 'Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem A Prospective, Consecutive Series, Multi-center Clinical Study', 'orgStudyIdInfo': {'id': '2011SMFH132_R11007-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SMF mini-stem hip replacement recipient', 'description': 'Received the device via total hip arthroplasty', 'interventionNames': ['Device: Total hip arthroplasty']}], 'interventions': [{'name': 'Total hip arthroplasty', 'type': 'DEVICE', 'otherNames': ['Total hip replacement'], 'description': 'Total hip arthroplasty', 'armGroupLabels': ['SMF mini-stem hip replacement recipient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Berchem', 'country': 'Belgium', 'facility': 'ZNA Middleheim', 'geoPoint': {'lat': 51.19021, 'lon': 4.43264}}, {'zip': 'M5C1R6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '5701', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Maisonneuve Rosemont, Hmr', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "CHUQ-L'Hôtel-Dieu de Québec", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '22024', 'city': 'Brakel', 'country': 'Germany', 'facility': 'St. Vincenz Hospital', 'geoPoint': {'lat': 51.7175, 'lon': 9.18596}}, {'zip': '33098', 'city': 'Paderborn', 'country': 'Germany', 'facility': 'Brüderkrankenhaus St. Josef', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}], 'overallOfficials': [{'name': 'Sobia Parveen', 'role': 'STUDY_CHAIR', 'affiliation': 'Smith & Nephew, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}