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CompletedNCT02308813Updated Feb 2, 2016

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

An interventional study of Braking and functionality in Osteoarthritis and Total Hip Arthroplasty, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-02.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Osteoarthritis
  • Total Hip Arthroplasty

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Braking and functionality with hip osteoarthritis

    Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with hip osteoarthritis

    Other: Braking and functionality

  • Experimental
    Braking and functionality with hip arthroplasty

    Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with total hip arthroplasty

    Other: Braking and functionality

Interventions

  • OtherBraking and functionality
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What researchers measure

Primary outcomes

  1. 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.

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

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Study locations

1 site
  • University Hospital Tuebingen, Department of Orthopaedics
    Tuebingen, 72076, Germany
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References and documents

Publications

  • 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. PubMed 10795670 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02308813
Lead sponsor
University Hospital Tuebingen
Responsible party
Sponsor
First posted
Dec 4, 2014
Start date
Oct 2014
Primary completion
May 2015
Completion
Jun 2015
Last update
Feb 2, 2016

Study contacts

Ulf K Hofmann, MD
principal investigator · University Hospital Tuebingen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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