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Clinical Trials/NCT02175160
NCT02175160CompletedNot Applicable

Predictability of the Ability to Perform an Emergency Stop in Knee Osteoarthritis and Patients With Total Knee Arthroplasty

University Hospital Tuebingen1 site in 1 country60 target enrollmentStarted: July 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Correlation of knee functionality 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 knee osteoarthritis and patients who have received total knee 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
  • •right or left knee Osteoarthritis, Total knee arthroplasty right or left knee
  • •capability to walk with or without a walking stick

Exclusion Criteria

  • •myocardial infarction/Apoplexia < 6 months
  • •Total knee 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, Tilidin)

Arms & Interventions

Braking and functionality with right knee osteoarthritis

Experimental

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

Intervention: Braking and functionality (Other)

Braking and functionality with right knee arthroplasty

Experimental

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

Intervention: Braking and functionality (Other)

Outcomes

Primary Outcomes

Correlation of knee functionality and braking performance

Time Frame: Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation

Evaluation of degree of correlation of braking performance (total brake response time) and clinical testing of knee functionality in patients with right knee osteoarthritis or total knee arthroplasty. 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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