Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip
Primary Purpose
Osteoarthritis, Total Hip 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
Eligibility Criteria
Inclusion Criteria:
- 18-85 y
- valid driving license
- male and female
- Hip Osteoarthritis, Total hip arthroplasty
- capability to walk with or without a walking stick
Exclusion Criteria:
- myocardial infarction/Apoplexia < 6 months
- Total hip 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, Til
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 hip osteoarthritis
Braking and functionality with hip arthroplasty
Arm Description
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with hip osteoarthritis
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with total hip arthroplasty
Outcomes
Primary Outcome Measures
Correlation of an index of manual reaction time combined with functional hip tests and braking performance
Evaluation of degree of correlation of braking performance (total brake response time) and clinical testing of hip functionality in patients with hip osteoarthritis or total hip arthroplasty. The measure is a composite measure of multiple different tests. If a sufficient correlation between the composite measure and braking performance is observed a regression model will be developed.
One time point of evaluation for each participant.
Secondary Outcome Measures
Full Information
NCT ID
NCT02308813
First Posted
October 27, 2014
Last Updated
February 1, 2016
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT02308813
Brief Title
Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip
Official Title
Predictability of Braking Performance in Patients With Degenerative Disease of the Hip Joint or With Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 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 hip osteoarthritis and patients who have received total hip 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 Hip Arthroplasty
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Braking and functionality with hip osteoarthritis
Arm Type
Experimental
Arm Description
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with hip osteoarthritis
Arm Title
Braking and functionality with hip arthroplasty
Arm Type
Experimental
Arm Description
Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with total hip arthroplasty
Intervention Type
Other
Intervention Name(s)
Braking and functionality
Primary Outcome Measure Information:
Title
Correlation of an index of manual reaction time combined with functional hip tests and braking performance
Description
Evaluation of degree of correlation of braking performance (total brake response time) and clinical testing of hip functionality in patients with hip osteoarthritis or total hip arthroplasty. The measure is a composite measure of multiple different tests. If a sufficient correlation between the composite measure and braking performance is observed a regression model will be developed.
One time point of evaluation for each participant.
Time Frame
Osteoarthritis group: cross sectional at consultation, Total hip arthroplasty group: cross-sectional - from 5 weeks postoperatively until 400 months 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
Hip Osteoarthritis, Total hip arthroplasty
capability to walk with or without a walking stick
Exclusion Criteria:
myocardial infarction/Apoplexia < 6 months
Total hip 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, Til
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
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Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip
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