search
Back to results

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
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis focused on measuring Driver reaction time

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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)

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

First Posted
June 11, 2014
Last Updated
February 1, 2016
Sponsor
University Hospital Tuebingen
search

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