Predictability of the Ability to Perform an Emergency Stop

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty; Osteoarthritis
• Interventions: Other: Braking and functionality

• Registration Number: NCT02175160
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-26
• Study Start: 2014-07
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Braking and functionality with right knee arthroplasty	Braking and functionality	Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right total knee arthroplasty
Braking and functionality with right knee osteoarthritis	Braking and functionality	Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis

Primary Outcome Measures

Name	Time	Method
Correlation of knee functionality and braking performance	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.

Trial Locations

Locations (1)

University Hospital Tuebingen, Department of Orthopaedics; 🇩🇪 Tuebingen, Germany