Predictability of the Ability to Perform an Emergency Stop
Primary Purpose
Osteoarthritis, Total Knee Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Braking and functionality
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoarthritis focused on measuring Driver reaction time
Eligibility 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)
Sites / Locations
- University Hospital Tuebingen, Department of Orthopaedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Braking and functionality with right knee osteoarthritis
Braking and functionality with right knee arthroplasty
Arm Description
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right total knee arthroplasty
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02175160
First Posted
June 11, 2014
Last Updated
February 1, 2016
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT02175160
Brief Title
Predictability of the Ability to Perform an Emergency Stop
Official Title
Predictability of the Ability to Perform an Emergency Stop in Knee Osteoarthritis and Patients With Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Total Knee Arthroplasty
Keywords
Driver reaction time
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Braking and functionality with right knee osteoarthritis
Arm Type
Experimental
Arm Description
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis
Arm Title
Braking and functionality with right knee arthroplasty
Arm Type
Experimental
Arm Description
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right total knee arthroplasty
Intervention Type
Other
Intervention Name(s)
Braking and functionality
Primary Outcome Measure Information:
Title
Correlation of knee functionality and braking performance
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.
One time point of evaluation for each participant.
Time Frame
Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf K Hofmann, MD
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tuebingen, Department of Orthopaedics
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
10795670
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.
Results Reference
result
Learn more about this trial
Predictability of the Ability to Perform an Emergency Stop
We'll reach out to this number within 24 hrs