Predictability of the Ability to Perform an Emergency Stop

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175160
• Other study ID #: 619/2013BO2
• Status: Completed
• Phase: N/A
• First received: June 11, 2014
• Last updated: February 1, 2016
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18-85 y

• 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)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Osteoarthritis
• Total Knee Arthroplasty

Intervention

Other:
• Braking and functionality

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen, Department of Orthopaedics	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes