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Clinical Trials/NCT02308813
NCT02308813CompletedNot Applicable

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

University Hospital Tuebingen1 site in 1 country100 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Correlation of an index of manual reaction time combined with functional hip tests and braking performance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Arms & Interventions

Braking and functionality with hip osteoarthritis

Experimental

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

Intervention: Braking and functionality (Other)

Braking and functionality with hip arthroplasty

Experimental

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

Intervention: Braking and functionality (Other)

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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