NCT02175160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 2, 2016

Status Verified

June 1, 2014

Enrollment Period

10 months

First QC Date

June 11, 2014

Last Update Submit

February 1, 2016

Conditions

OsteoarthritisTotal Knee Arthroplasty

Keywords

Driver reaction time

Outcome Measures

Primary Outcomes (1)

  • Correlation of knee functionality and braking performance

    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.

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

Study Arms (2)

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

Other: Braking and functionality

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

Other: Braking and functionality

Interventions

Braking and functionalityOTHER
Braking and functionality with right knee arthroplastyBraking and functionality with right knee osteoarthritis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen, Department of Orthopaedics

Tübingen, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 10795670RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ulf K Hofmann, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 26, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

February 2, 2016

Record last verified: 2014-06

Locations

DE(1)