Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-27 @ 6:49 AM
Study NCT ID:
NCT03233620
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-27', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of contemporary knee arthroplasty in working-age patients', 'timeFrame': '2 years', 'description': 'PROMs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee arthroplasty', 'working-age', 'patient related outcome measures'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '34353317', 'type': 'DERIVED', 'citation': 'Leppanen S, Niemelainen M, Huhtala H, Eskelinen A. Mild knee osteoarthritis predicts dissatisfaction after total knee arthroplasty: a prospective study of 186 patients aged 65 years or less with 2-year follow-up. BMC Musculoskelet Disord. 2021 Aug 5;22(1):657. doi: 10.1186/s12891-021-04543-8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study was to assess the effectiveness of contemporary knee arthroplasty in working-age patients (\\< 65 years) by conducting a prospective cohort study with 2-year follow up. Outcomes were measured comprehensively using various patient-reported outcome measures (PROMs) to provide information on the effect of knee arthroplasty on pain, satisfaction, physical activity, activities of daily living, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 65 or less and\n* Scheduled for either TKA or unicondylar knee arthroplasty (UKA)\n\nExclusion Criteria:\n\n* rheumatoid arthritis or other inflammatory diseases\n* unwilling to provide informed consent\n* physical, mental, or neurological conditions that could comprise the patient´s ability and compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson's disease, multiple sclerosis (MS), etc.)\n* known sensitivity to materials in the devices."}, 'identificationModule': {'nctId': 'NCT03233620', 'briefTitle': 'Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients', 'organization': {'class': 'OTHER', 'fullName': 'Coxa, Hospital for Joint Replacement'}, 'officialTitle': 'Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients: a Prospective Study With 2-year Follow-up', 'orgStudyIdInfo': {'id': 'R11178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'working age patients', 'description': 'Prospective cohort of 250 patients.', 'interventionNames': ['Other: Knee arthroplasty']}], 'interventions': [{'name': 'Knee arthroplasty', 'type': 'OTHER', 'description': 'Effectiveness of knee arthroplasty surgery.', 'armGroupLabels': ['working age patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coxa, Hospital for Joint Replacement', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}