Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictability of the Ability to Perform an Emergency Stop

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175160
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Total Knee Arthroplasty Other: Braking and functionality Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictability of the Ability to Perform an Emergency Stop in Knee Osteoarthritis and Patients With Total Knee Arthroplasty
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Braking and functionality with right knee osteoarthritis
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis
Other: Braking and functionality
Experimental: Braking and functionality with right knee arthroplasty
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right total knee arthroplasty
Other: Braking and functionality



Primary Outcome Measures :
  1. Correlation of knee functionality and braking performance [ Time Frame: Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation ]

    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.

    One time point of evaluation for each participant.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-85 y
  • valid driving license
  • male and female
  • right or left knee Osteoarthritis, Total knee arthroplasty right or left knee
  • capability to walk with or without a walking stick

Exclusion Criteria:

  • myocardial infarction/Apoplexia < 6 months
  • Total knee arthroplasty <5 weeks
  • New York Heart Association 3/4
  • lacking drivers' license
  • peripheric sensomotor deficit <3/5 British Medical Research Council
  • new fracture of the lower extremity or spine
  • systemic or metastasised Cancer
  • drug intake with centrally acting substances known to affect reaction time (Opioids, e.g. Tramadol, oxycodone, morphine, Tilidin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175160


Locations
Layout table for location information
Germany
University Hospital Tuebingen, Department of Orthopaedics
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Layout table for investigator information
Principal Investigator: Ulf K Hofmann, MD University Hospital Tuebingen
Publications of Results:
Layout table for additonal information
Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02175160    
Other Study ID Numbers: 619/2013BO2
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: June 2014
Keywords provided by University Hospital Tuebingen:
Driver reaction time
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Emergencies
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Disease Attributes
Pathologic Processes