Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-12 @ 12:41 AM
Study NCT ID:
NCT02175160
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2014-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictability of the Ability to Perform an Emergency Stop
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-01', 'studyFirstSubmitDate': '2014-06-11', 'studyFirstSubmitQcDate': '2014-06-23', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of knee functionality and braking performance', 'timeFrame': 'Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation', 'description': 'Evaluation of degree of correlation of braking performance (total brake response time) and clinical testing of knee functionality in patients with right knee osteoarthritis or total knee arthroplasty.\n\nOne time point of evaluation for each participant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Driver reaction time'], 'conditions': ['Osteoarthritis', 'Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '10795670', 'type': 'RESULT', 'citation': 'Hau R, Csongvay S, Bartlett J. Driving reaction time after right knee arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2000;8(2):89-92. doi: 10.1007/s001670050192.'}]}, 'descriptionModule': {'briefSummary': 'Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. This study aims at evaluating different possibilities how such performance might be predicted. Patients with knee osteoarthritis and patients who have received total knee arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-85 y\n* valid driving license\n* male and female\n* right or left knee Osteoarthritis, Total knee arthroplasty right or left knee\n* capability to walk with or without a walking stick\n\nExclusion Criteria:\n\n* myocardial infarction/Apoplexia \\< 6 months\n* Total knee arthroplasty \\<5 weeks\n* New York Heart Association 3/4\n* lacking drivers' license\n* peripheric sensomotor deficit \\<3/5 British Medical Research Council\n* new fracture of the lower extremity or spine\n* systemic or metastasised Cancer\n* drug intake with centrally acting substances known to affect reaction time (Opioids, e.g. Tramadol, oxycodone, morphine, Tilidin)"}, 'identificationModule': {'nctId': 'NCT02175160', 'briefTitle': 'Predictability of the Ability to Perform an Emergency Stop', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Predictability of the Ability to Perform an Emergency Stop in Knee Osteoarthritis and Patients With Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '619/2013BO2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Braking and functionality with right knee osteoarthritis', 'description': 'Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis', 'interventionNames': ['Other: Braking and functionality']}, {'type': 'EXPERIMENTAL', 'label': 'Braking and functionality with right knee arthroplasty', 'description': 'Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right total knee arthroplasty', 'interventionNames': ['Other: Braking and functionality']}], 'interventions': [{'name': 'Braking and functionality', 'type': 'OTHER', 'armGroupLabels': ['Braking and functionality with right knee arthroplasty', 'Braking and functionality with right knee osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Hospital Tuebingen, Department of Orthopaedics', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Ulf K Hofmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}