Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Total Hip Arthroplasty

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tuebingen, Department of Orthopaedics

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Braking and functionality

Other

Primary outcomes

Correlation of an index of manual reaction time combined with functional hip tests and braking performance

Time frame: Osteoarthritis group: cross sectional at consultation, Total hip arthroplasty group: cross-sectional - from 5 weeks postoperatively until 400 months postoperatively, at consultation

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.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Predictability of Braking Performance in Patients With Degenerative Disease of the Hip Joint or With Total Hip Arthroplasty

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Dec 4, 2014
Registry last updated: Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed