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

Not Applicable

Completed

• Conditions: Osteoarthritis; Total Hip Arthroplasty
• Interventions: Other: Braking and functionality

• Registration Number: NCT02308813
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-27
• Status Verified: 2014-11
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Braking and functionality with hip osteoarthritis	Braking and functionality	Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with hip osteoarthritis
Braking and functionality with hip arthroplasty	Braking and functionality	Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with total hip arthroplasty

Primary Outcome Measures

Name	Time	Method
Correlation of an index of manual reaction time combined with functional hip tests and braking performance	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.

Trial Locations

Locations (1)

University Hospital Tuebingen, Department of Orthopaedics; 🇩🇪 Tuebingen, Germany