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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02308813
Enrollment
100
Registered
2014-12-04
Start date
2014-10-31
Completion date
2015-06-30
Last updated
2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Total Hip Arthroplasty

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.

Interventions

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of an index of manual reaction time combined with functional hip tests and braking performanceOsteoarthritis group: cross sectional at consultation, Total hip arthroplasty group: cross-sectional - from 5 weeks postoperatively until 400 months postoperatively, at consultationEvaluation 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026