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Predictability of the Ability to Perform an Emergency Stop

U

University Hospital Tuebingen

Status

Completed

Conditions

Osteoarthritis
Total Knee Arthroplasty

Treatments

Other: Braking and functionality

Study type

Interventional

Funder types

Other

Identifiers

NCT02175160
619/2013BO2

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Braking and functionality with right knee osteoarthritis
Experimental group
Description:
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis
Treatment:
Other: Braking and functionality
Braking and functionality with right knee arthroplasty
Experimental group
Description:
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right total knee arthroplasty
Treatment:
Other: Braking and functionality

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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