Predictability of the Ability to Perform an Emergency Stop

Study Overview
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Brief Summary
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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.

Official Title
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Predictability of the Ability to Perform an Emergency Stop in Knee Osteoarthritis and Patients With Total Knee Arthroplasty

Conditions
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Osteoarthritis, Total Knee Arthroplasty

Intervention / Treatment
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* Other: Braking and functionality


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Braking and functionality with right knee osteoarthritis<br>Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis | Other: Braking and functionality<br> <br> |
| Experimental: Braking and functionality with right knee arthroplasty<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of knee functionality and braking performance | 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. | Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Driver reaction time